Articles

Posts Tagged Cancer

Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

(more…)

Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (30) →

“Integrative” oncology: Trojan horse, quackademic medicine, or both?

One of the main topics that we’ve covered here on this blog over the last couple of years is the relatively rapid, seemingly relentless infiltration of pseudoscience into what should be bastions of science-based medicine (SBM), namely medical schools and academic medical centers promoted by academics who should, but apparently don’t, know better. From the very beginning, we’ve written numerous posts about this infiltration and how it has been facilitated by a variety of factors, including changes in the culture of medical academia and our own culture in general, not to mention a dedicated cadre of ideologues such as the Bravewell Collaboration, whose purpose is to blur the lines between science and pseudoscience and promote the “integration” of quackery into science-based medicine. Certainly promoters of what Dr. Robert W. Donnell termed “quackademic medicine” wouldn’t put it that way, but I would. Indeed, promoters of quackademic medicine scored a major victory last month, when a credulous piece of tripe about acupuncture passing as a review article managed to find its way into the New England Journal Medicine, a misstep that was promptly skewered by Mark Crislip, Steve Novella, and myself. It’s rare for more than two of us to write about the same topic, but it was earned by a mistake as dire as the editors of the NEJM allowing rank pseudoscience to sully its normally science-based pages.

Today, I want to riff a bit on one aspect of this phenomenon. As a cancer surgeon, I’ve dedicated myself to treating patients with cancer and then subspecialized even further, dedicating myself to the surgical treatment of breast cancer. Consequently, the interface of so-called “complementary and alternative medicine” (CAM) in the treatment of cancer both interests and appalls me. The reason for my horror at the application of CAM to cancer patients, as you might expect, is that cancer is a disease that is highly feared and can be highly deadly, depending upon the specific kind of cancer. Cancer patients deserve nothing less than the best science-based evidence that we have to offer, free of pseudoscience. Yet in even the most highly respected cancer centers, such as M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center, there are departments or divisions of what is increasingly called “integrative oncology.” The claim behind “integrative oncology” is that it is “integrating the best of science-based and ‘alternative’ medicine,” but in reality all too often it is “integrating” quackery with science-based medicine. I have yet to hear an explanation of how “integrating” pseudoscience or nonscience into science-based oncology benefits cancer patients, but, then, that’s probably just the nasty old reductionist in me. Let’s find out.
(more…)

Posted in: Acupuncture, Cancer, Homeopathy, Naturopathy

Leave a Comment (29) →

Red Meat: Is It Hazardous to Health?

Red meat consumption has been linked to diabetes, cardiovascular disease, and several types of cancer (breast, colorectal, stomach, bladder, prostate, and lymphoma). There are plausible mechanisms: meat is a source of carcinogens, iron that may increase oxidative damage, and saturated fat. But correlation and plausibility are not enough to establish causation. Is red meat really dangerous? If so, how great is the risk? A couple of recent studies have tried to shed light on these questions, but they have raised more questions than they have answered.

A Systematic Review and Meta-Analysis

A new study in Circulation, “Red and Processed Meat Consumption and Risk of Incident Coronary Heart Disease, Stroke, and Diabetes Mellitus. A Systematic Review and Meta-Analysis,” by Micha, Wallace and Mozaffarian, is a systematic review of the literature. It analyzed 17 prospective cohort studies and 3 case-control studies, with a total of 1.2 million subjects. As far as I can judge, it appears to be a well-done systematic review with excellent methodology and multiple precautions. They even looked for things like publication bias (which they did not find).

They found that the consumption of processed meats, but not red meats, is associated with a higher incidence of coronary heart disease and diabetes. (Processed meats include bacon, sausage, ham, hot dogs, salami, luncheon meat and other cured meats.) The increased risk per 50 gram serving of processed meats per day was 42% for heart disease and 19% for diabetes. Unprocessed red meats were not associated with CHD and were associated with a nonsignificant trend towards higher risk of diabetes. They found no association with stroke, but this was based only on 3 studies.
(more…)

Posted in: Cancer, Nutrition

Leave a Comment (38) →

The latest chapter in the seemingly never-ending saga of dichloroacetate as a cancer treatment

The road from an idea to a useful drug is a long one, and in cancer it is often particularly long. One reason is that to be able to tell whether a given treatment is effective against cancer often takes several years at a minimum, in order to determine if patients receiving the new treatment are surviving their disease longer than those who are not. Surrogate endpoints are usually not enough. Tumor shrinkage in response to a drug often does not correlate with prolongation of survival, although the converse (i.e., lack of tumor shrinkage in response to a new drug) does strongly correlate with failure of a treatment to prolong survival. In other words, effects observed on surrogate endpoints are not enough to judge whether a cancer therapy is working or not.

Three years ago, predating the existence of this blog by nearly a year, I became aware of a story that involved many of the issues in bringing a compound from the laboratory to the clinic. The case was unusual in that is is very rare to see the scientific process by which new drugs progress through the stages of cancer research, from concept to testing in cell culture to testing in animals to testing in humans challenged so strongly by patients themselves. The reason that this normally doesn’t occur is that new cancer treatments are almost always the product of either university-conducted research, pharmaceutical company-conducted research, or partnerships between the two. This case was markedly different in that it involved a chemical that was not only easy to synthesize, but cheap and long out of patent. Even more intriguing, it targeted a metabolic abnormality found in many cancer cells, an abnormality first described nearly 80 years before by Otto Warburg in 1928. This latter aspect of the drug gave it every appearance of a “rediscovery” of old wisdom that big pharma had ignored for 80 years, and that only added to its mystique.

The chemical was dichloroacetate (DCA), and three years ago it created a world-wide sensation. Last week, it created a sensation again, as breathless news reports once again overhyped its promise. Since I’ve been following the story since early 2007, I appear to be in as good a position as anyone to tell the story thus far and put the new findings into context. To begin that process, let’s head back to January 2007.
(more…)

Posted in: Cancer, Clinical Trials, Health Fraud

Leave a Comment (48) →

The 2008-2009 Report of the President’s Cancer Panel: Mostly good, some bad, and a little ugly

Mark Crislip is always a hard act to follow, particularly when he’s firing on all cylinders, as he was last Friday. Although I can sometimes match him (and, on rare occasions, even surpass him) for amusing snark, this time around I’m going to remain mostly serious because that’s what the subject matter requires. I’ve said it before and I’ll say it again: I’m a bit of an odd bird in the world of cancer in that I’m both a surgeon and I run a lab. Sadly, there just aren’t very many surgeons doing basic and translational research these days, thanks to declining NIH funding, increasing clinical burden necessitated by declining reimbursements, and the increasing complexity of laboratory-based research. That’s not to say that there aren’t some surgeons out there doing excellent laboratory research, but sometimes I feel as though I’m part of an endangered species, particularly years like this when grants are running out and I need to renew my funding or secure new funding, the consequence of failure being the dissolution of my laboratory. It’s a tough world out there in biomedical research.

As tough as biomedical research is in cancer, to my mind far tougher is research trying to tease out the relationship between environmental exposures and cancer risk. If you want complicated, that’s complicated. For one thing, obtaining epidemiological data is incredibly labor- and cost-intensive, and rarely are the data clear cut. There’s always ambiguity, not to mention numerous confounding factors that conspire to exaggerate on the one hand or hide on the other hand correlations between environmental exposures and cancer. As a result, studies are often conflicting, and making sense of the morass of often contradictory studies can tax even the most skillful scientists and epidemiologists. Communicating the science and epidemiology linking environment and cancer to the public is even harder. What the lay person often sees is that one day a study is in the news telling him that X causes cancer and then a month later another study says that X doesn’t cause cancer. Is it any wonder that people are often confused over what is and is not dangerous? Add to this a distinct inability on the part of most people, even highly educated people, to weigh small risks against one another (an inability that has led to phenomena such as the anti-vaccine movement), and the task of trying to decide what is dangerous, what is not, how policy is formulated based on this science, and how to communicate the science and the policy derived from it to the public is truly Herculean.
(more…)

Posted in: Cancer, Politics and Regulation, Public Health

Leave a Comment (29) →

The complexity of cancer: A science-based view

Last week I participated in a panel discussion at NECSS with John Snyder, Kimball Atwood, and Steve Novella, who reported on the conference last Monday. What I mentioned to some of the attendees is that I had managed to combine NECSS with a yearly ritual that I seldom miss, namely the yearly meeting of the American Association for Cancer Research (AACR) meeting. There are two huge cancer meetings every year, AACR and the annual meeting of the American Society for Clinical Oncology (ASCO). AACR is the meeting dedicated to basic and translational research; ASCO, as the word “clinical” in its name implies, is devoted mainly to clinical research. Personally, being a translational researcher myself and a surgeon, I tend to prefer the AACR meeting over ASCO, not because ASCO isn’t valuable, but mainly because ASCO tends to be devoted mostly to medical oncology and chemotherapy, which are not what I do as a surgeon. Each meeting draws between 10,000 to 15,000 or even more clinicians and researchers dedicated to the eradication of cancer.

Having taken the Acela train from the NECSS meeting in New York straight to Washington, DC for the AACR meeting, I couldn’t help but think a bit about the juxtaposition of our discussion of the infiltration of quackademic medicine into medical academia with the hard core science being discussed at AACR. One session in particular at AACR highlighted what is one of the most significant differences between science-based medicine and the various forms of “alternative” medicine that we discuss here on SBM on such a regular basis. That difference, quite simply put, is the difference between the simple and the complex. “Alternative” medicine supporters often scoff at practitioners of science-based oncology, asking why we don’t have a “cure for cancer” yet—as if cancer were a single disease!—or why we haven’t made much more progress since President Richard Nixon declared “war on cancer” back in 1971. One part of the answer is that cancer is incredibly complicated. Not only is it not a single disease, but each variety of cancer is in and of itself incredibly complicated as well. To steal from Douglas Adams, cancer is complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think algebra is complicated, but that’s just peanuts to cancer.
(more…)

Posted in: Cancer

Leave a Comment (44) →

Chemotherapy versus death from cancer

Editor’s Note: Having pivoted immediately (and dizzyingly) from attending NECSS and participating with John Snyder, Kimball Atwood, and Steve Novella in a panel on the infiltration of quackery into academia to heading down to Washington, DC for the AACR meeting, I’ve neglected my SBM duties a bit this week. After a packed day of talks at the AACR meeting followed by spending an evening with a friend whom I haven’t seen for a long time (complete with a trip to The Brickskeller), there’s–gasp!–no new material today. Because for some reason a decision was apparently made to cut our panel very short in order to get the conference back on schedule, we were unable to answer anywhere near as many questions from the audience as we had originally hoped, I was thinking of doing a post trying to answer a couple of the questions asked by audience members who came up to me after the panel terminated prematurely, because one of them was a particularly dicey situation. Maybe later this week. In the meantime, here’s something that I wrote about a year ago, which I tweaked a bit. It’s a very serious topic, but I think it appropriate because it discusses exactly what science-based medicine tries to prevent using evidence and what “alternative medicine” claims it can prevent based on no evidence.

I’ve written before about the Daniel Hauser case, a 13 year old boy who last year refused chemotherapy for his Hodgkin’s lymphoma, necessitating the involvement of the legal system. Cases like that of Daniel Hauser reprsent supreme “teachable” moments that–fortunately–don’t come along that often. The antivaccine movement, for instance, will be with us always (or at least, I fear, as long as I still walk this earth and beyond), but cases like that of Daniel Hauser tend to pop up only once every couple of years or even less. As tragic as they are, they always bring up so many issues that I have a hard time leaving them alone.

This time around, I wanted to touch on an issue that has come up frequently in the discussions of this case, and that’s the issue of chemotherapy. Specifically, it’s the issue of how horrible chemotherapy can be. Again, make no mistake about it, chemotherapy can be rough. Very rough. But what is often forgotten is that it can also be life-saving, particularly in the case of hematologic malignancies, where it is the primary therapy. What is also often forgotten or intentionally ignored by promoters of unscientific medicine is that doctors don’t use chemotherapy because they have some perverted love of “torturing” patients, because they’re in the pockets of big pharma and looking for cash, or because they are too lazy to find another way. They do it because, at least right now, it’s the best therapy science-based medicine has to offer, and in the case of Hodgkin’s lymphoma, for example, it’s life-saving. You can be sure that if a less harsh way were found to achieve the same results, physicians would jump all over it. Indeed, a major focuse of oncology research these days is to find less brutal regimens and improve the quality of life of cancer patients while still giving them the best shot at survival.
(more…)

Posted in: Cancer, Pharmaceuticals

Leave a Comment (68) →

Biologie Totale and other bastard offspring of Ryke Geerd Hamer’s German New Medicine

A few months ago, I wrote about a particularly nasty form of cancer quackery known as the “German New Medicine” or Die Germanische Neue Medizin in German. As you may recall, the German New Medicine is based on the nonsensical idea that cancer arises from an internal emotional conflict. This conflict then results in what is called the “Dirk Hamer Syndrome” (DHS) or “Dirk Hamer focus” in the brain, named after Dr. Ryke Geerd Hamer‘s son Dirk, who was tragically shot in his sleep by Vittorio Emanuel, the last crown prince of Italy. After a prolonged course requiring multiple operations, Dirk succumbed to his wounds and died. Three years later, Dr. Hamer developed testicular cancer, and, in a perfect case of post hoc ergo propter hoc, Hamer decided that it was the psychic shock of his son’s death that had caused his cancer. Thus was born Die Germanische Neue Medizin, which, according to Hamer, promises a 95% or more chance of curing any cancer, no matter how advanced. Never mind that Hamer apparently underwent a combination of surgery and other “conventional therapies for his testicular cancer. Also never mind that these “Dirk Hamer Focus” to which Hamer pointed on CT scans of the brain appeared, more than anything else, to be artifacts of the imaging process and nothing real.

As I described in my previous post in October, the German New Medicine is a seriously dangerous form of cancer quackery that is not only worthless but in many cases blames the patient for having developed cancer. Evidence can be found in this video, where a proponent of German New Medicine gives as examples of psychic stress a “cancer blow” that comes from menopause, in which loss of estrogen supposedly leads women to feel that they “aren’t the woman they used to be” and that that conflict is manifest in the bone or an athlete’s anger because of an injury that screws up his ability to perform leading to an osteosarcoma of extremity.

Unfortunately, cancer quackery frequently evolves under the selective pressure of competition with other cancer quackeries and based on the unique environments in which various forms of quackery come to land. Since I first wrote my post about Die Germanische Neue Medizin, I’ve been meaning to address one of its offshoots. The particular offshoot that I plan to address is, in essence, the French cousin of Die Germanische Neue Medizin, and it’s called Biologie Totale, or Total Biology (Claude Sabbah’s official site is here, but it’s all in French). I first became aware of Biologie Totale about a year and a half ago through this news story:
(more…)

Posted in: Cancer, Health Fraud

Leave a Comment (22) →

Faith Healing

Faith healing is based on belief and is about as far as you can get from science-based medicine, but it is not exempt from science. If it really worked, science would be able to document its cures and would be the only reliable way to validate its effectiveness. Miraculous cures continue to be reported on a regular basis: what are we to make of them? In the Healing Rooms Ministry of Bethel Church in Redding, California, people regularly claim to be healed of cancer, broken bones, multiple sclerosis and many other ailments. Page after page of testimonials of cures are listed on their website. Are these cures real? If not, what is going on?

Amanda Winters, a journalist doing a series of articles on Bethel Church, interviewed me for a scientific view of these faith healings. She asked me some very incisive questions and understood my answers. She wrote what I thought was a balanced article, quoting me fairly and at more length than reporters usually allow.

Her article features a patient who believed his flat feet would be healed (bones would crack and form an arch). Healers poked him, blew a shofar at his feet, and covered him with a blanket when he collapsed on the floor. When he got up, his feet were unchanged. But

his faith was not shaken, he said, because he felt so loved and maybe the physical healing was secondary to the spiritual experience he had. (more…)

Posted in: Faith Healing & Spirituality

Leave a Comment (25) →

Radiation from medical imaging and cancer risk

ResearchBlogging.orgScience-based medicine consists of a balancing of risks and benefits for various interventions. This is sometimes a difficult topic for the lay public to understand, and sometimes physicians even forget it. My anecdotal experience suggests that probably surgeons are usually more aware of this basic fact because our interventions generally involve taking sharp objects to people’s bodies and using steel to remove or rearrange parts of people’s anatomy for (hopefully) therapeutic effect. Ditto oncologists, who prescribe highly toxic substances to treat cancer, the idea being that these substances are more toxic to the cancer than they are to the patient. Often they are only marginally more toxic to the cancer than to the patient. However, if there’s one area where even physicians tend to forget that there is potential risk involved, it’s the area of diagnostic tests, in particular radiological diagnostic tests, such as X-rays, fluoroscopy, computed tomography (CT) scans, and the variety of ever more powerful diagnostic studies that have proliferated over since CT scans first entered medical practice in the 1970s. Since then, the crude images that the first CT scans produced have evolved, thanks to technology and ever greater computing power, to breathtaking three dimensional-views of the internal organs. Indeed, just since I finished medical school back in the late 1980s, I’m continually amazed at what these new imaging modalities can accomplish.

The downside of these imaging modalities is that most of them require the use of X-rays to produce their images. True, over the last 15 years or so MRI, which uses very strong magnetic fields and radiofrequency radiation rather than ionizing radiation to produce its images, has become increasingly prevalent. MRI is great because it produces more contrast between different kinds of soft tissue than CT scans do. However, CT tends to be superior for examining calcified organs, such as bone. (The breast surgeon in me notes that breast MRI is pretty much useless for detecting microcalcifications, an important possible indicator for cancer.) Also, MRI scans require a prolonged period of laying still in a very tight tube, which is a problem for patients with any degree of claustrophobia, although “open” MRIs are becoming increasingly available. More importantly for the quality of images, because they require a patient to lie more still than a CT, MRIs tend to be prone to more motion artifacts, which is perhaps why CT is more frequently used to image the abdomen other than large solid organs such as the liver. The point is that, although MRI is becoming more prevalent, CT scans aren’t going away any time soon. They have different strengths and weaknesses as imaging modalities and are therefore best suited for different, albeit overlapping, sets of indications.
(more…)

Posted in: Cancer, Public Health

Leave a Comment (37) →
Page 7 of 9 «...56789