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The New England Journal of Medicine Disappoints

On July 31 of this year, a collective groan could be heard emanating from critics of pseudomedicine. The causative factors (which is medical bombast for “the cause”) were two book reviews published in the usually staid New England Journal of Medicine (NEJM):

Integrative Oncology: Incorporating Complementary Medicine into Conventional Cancer Care

Edited by Lorenzo Cohen and Maurie Markman. 216 pp., illustrated. Totowa, NJ, Humana Press, 2008. $79.95. ISBN 978-1-58829-869-0.
Reviewed by Donald I. Abrams

Alternative Medicine? A History

By Roberta Bivins. 238 pp., illustrated. New York, Oxford University Press, 2008. $35. ISBN 978-0-19-921887-5.
Reviewed by Teresa L. Schraeder

The Wooification of Medical Journals

I’ll review the reviews, but first let’s consider why their presence in the NEJM is so disturbing. The NEJM is the most widely read and cited medical journal in the world. Among American journals, the top three are usually reckoned to be the NEJM, the Journal of the American Medical Association (JAMA) and, at least for internists, the Annals of Internal Medicine (Ann Int Med). The extent to which each journal has sacrificed its integrity for the promotion of the recent wave of pseudomedicine has varied among the three: the NEJM rarely and, for the most part, unwittingly; JAMA famously in 1998 and occasionally since; and the Ann Int Med repeatedly and embarrassingly, most notably with a series of puff pieces on “CAM” that spanned several years and violated the Annals’ own policies regarding funding disclosures by authors and editors.

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Posted in: Book & movie reviews, Cancer, Medical Academia

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High dose vitamin C and cancer: Has Linus Pauling been vindicated?

ResearchBlogging.orgTHE ZOMBIE RISES AGAIN

Vitamin C as a treatment for cancer is back in the news again.

I’m not surprised. This is one therapy favored by advocates of “alternative” medicine that keeps popping up periodically (seemingly every couple of years or so). This latest bit of news has turned up almost right on time after the last time there was a push for rehabilitating vitamin C as a cancer cure a couple of years ago. Back in the spring of 2006, there were two studies published (more on them later) which were touted by the “complementary and alternative medicine” (CAM) crowd as evidence that Linus Pauling was supposedly vindicated. A little less than two weeks ago, an animal study was published suggesting that high-dose intravenous vitamin C had antitumor activity in mouse models. A couple of weeks prior, there had also been published a phase I clinical trial that showed that megadoses of IV ascorbate were safe and well-tolerated in cancer patients if they were appropriately screened for renal disease. Given the latest studies of this particular modality against cancer, it seemed like an opportune time for me to examine this new evidence and ask the question: Has Linus Pauling been vindicated?

I’ll cut to the chase. The short answer is: Not really, with the qualification that it depends on what you mean by “vindicated.” The long answer follows.
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Posted in: Basic Science, Cancer, Clinical Trials, Nutrition, Science and the Media

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The Orange Man

The first thing that struck me about him was that he was orange.

It was not a shade of orange I had ever ever encountered before in a patient. It was a yellowish orange, an almost artificial-looking color. At first I wondered if he was suffering from liver failure with jaundice, but this orange was just not the right shade of yellow for jaundice, and his sclerae were not yellow. I also considered whether he was suffering from renal failure, but the orange color of his skin didn’t quite match the rather coppery color that some patients suffering from longstanding renal failure necessitating dialysis sometimes acquire. I was puzzled. His chart said that he was being admitted for surgery for rectal cancer. So I sent the intern in to get the story, do the history and physical, and get him all plugged in for his bowel prep. Believe it or not, there was actually a time when it was not all that uncommon for patients to come into the hospital the night before major abdominal surgery in order to undergo a preoperative bowel prep, rather than being forced by their insurance companies to undergo the torture of drinking four liters of the purgative known as Go-Lytely–a misnomer, if ever there was one!–at home and spending the next several hours having to rush periodically to the toilet, waiting in vain for the liquid exploding out of their hind end to run clear.
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Posted in: Cancer, Clinical Trials, Science and Medicine, Surgical Procedures

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Cell phones and cancer again, or: Oh, no! My cell phone’s going to give me cancer!

Before I start into the meat of this post, I feel the need to emphasize, as strongly as I can, four things:

  1. I do not receive any funding from the telecommunications industry in general, or wireless phone companies in particular. None at all. In other words, I’m not in the pocket of “big mobile” any more than I am in the pocket of big pharma.
  2. I don’t own any stock in telecommunications companies, other than as parts of mutual funds in which my retirement funds are invested that purchase shares in many, many different companies, some of which may or may not be telecommunications companies. (I should probably go and look at the list.)
  3. None of my friends or family work for cell phone companies.
  4. I don’t have a dog in this hunt. I really don’t.

I say this because these are the most common accusations I hear whenever I venture into this particular topic area, and I thought I’d just clear that up right away in order (hopefully) to preempt any similar comments after this post. Indeed, one of the favorite retorts to anyone who criticizes fearmongering about cell phones is to try to insinuate that that person is only doing so because he or she is in the pocket of industry, and I’ve been at the receiving end of such claims. Unfortunately, I’m sure someone will probably show his or her lack of reading comprehension and post one of those very criticisms of me. It’s almost inevitable. Even though posting such disclaimers never works against the “pharma shill” gambit when I write about vaccines or dubious cancer cures, nonetheless hope springs eternal.

Now that that obligatory unpleasantness is out of the way, let me move on to say that I’m very puzzled about something that happened last week.

I know that being puzzled isn’t particularly unusual for me. Indeed, I’m frequently puzzled about a great many things. I can’t figure out how, for example, anyone with the slightest bit of reason or critical thinking ability can believe that homeopathy is anything other than water treated with, in essence, magical spells accompanied by shaking or do anything other than laugh when informed what homeopathy really is and how it supposedly “works.” I can’t figure out how anyone can look at the mass of interlocking evidence from multiple different scientific specialties supporting evolution and reject still reject one of the most powerful scientific theories ever to spring from the human mind, deciding instead that creationism or its bastard offspring, “intelligent design” creationism is anything more than pure religion or rank religion-inspired pseudoscience. I can’t figure out why American Idol or Survivor is so amazingly popular.

And I can’t figure out why on earth the University of Pittsburgh Cancer Center released this warning about cell phones last week:

PITTSBURGH July 24, 2008, 07:13 am ET · The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer.

The warning from Dr. Ronald B. Herberman, director of the University of Pittsburgh Cancer Institute, is contrary to numerous studies that don’t find a link between cancer and cell phone use, and a public lack of worry by the U.S. Food and Drug Administration.

Herberman is basing his alarm on early unpublished data. He says it takes too long to get answers from science and he believes people should take action now — especially when it comes to children.

“Really at the heart of my concern is that we shouldn’t wait for a definitive study to come out, but err on the side of being safe rather than sorry later,” Herberman said.

Dr. Herberman is a highly respected cancer center director whom I’ve in general thought well of, and the University of Pittsburgh Cancer Institute is a highly respected cancer center. I know a few people there, and in the past I’ve worked closely with two surgeons who trained there. One in particular remains my collaborator, even though I’ve moved on from the institution where we were once partners.

That’s why I can’t help but wonder just what on earth Dr. Herberman was smoking when he decided to issue this warning, given my general respect for the University of Pittsburgh to the point where I once even tried to land a faculty position there. His announcement strikes me as being rash in the extreme, especially given that its text even admits outright that the published data at present do not appear to support a link between cell phone use and brain tumors. Consequently, I conclude that this is alarmism that, I suspect, even a prominent blogger known to be somewhat receptive to the claim that cell phones cause brain tumors (Revere) would have a hard time supporting, because it goes far beyond the published evidence and is based on “early unpublished data.” Scaring the nation based on “early unpublished data” that can’t be examined by the entire medical and scientific community is generally not a good idea. That’s why I’ve been asking over the last few days: Why on earth did Dr. Herberman do it?
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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The FDA Cracks Down on Fake Cancer Cures

The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:

“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”

The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.

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Posted in: Cancer, Health Fraud, Politics and Regulation

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The media versus the frontiers of medicine and surgery

A couple of months ago, one of my esteemed co-bloggers, Wally Sampson, wrote an excellent article about borderlines in research in conventional medicine. Such borderlines are particularly common in my area of expertise (cancer, which is also Dr. Sampson’s area of expertise) because there are so many cancers for which we do not as yet have reliably curative therapies. Patients faced with unresectable pancreatic cancer (as, for example, Patrick Swayze and the President of the American Medical Association have been diagnosed with) or metastatic solid cancers against which medicine generally has mostly palliative treatments, it is very tempting to take a “what have we got to lose?” attitude and pursue increasingly aggressive therapies that may actually shorten what little life a patient has left, all too often making that little bit of life more miserable than it had to be. As Dr. Sampson described in great detail, this sort of push to the borderlines and beyond led to the widespread acceptance during the 1990s of bone marrow transplantation as a treatment for advanced or inflammatory breast cancer based on uncontrolled studies that suggested a benefit. Later studies demonstrated no survival benefit (and possibly even a detriment), and that, or so it would seem, was that.

Except it wasn’t. Indeed, the other point that Dr. Sampson made was how the press covers these sorts of issues. He discussed a story that appeared in the San Francisco Chronicle about a young woman with advanced breast cancer who underwent stem cell transplantation for stage IV breast cancer at M.D. Anderson Cancer Center and was embroiled in a fight with Kaiser Permanente, her insurer, which refused to cover the treatment because it was deemed experimental and was at the time covering the cost of radiation therapy but refusing to cover the costs of extra followup scans required by the M.D. Anderson protocol. The article, not surprisingly, covered the story from the angle of the brave young cancer victim being further victimized by a greedy insurance company. And Evanthia Pappas is no doubt brave, and no one could read about her plight without rooting for her to beat the odds. The problem is that no consideration was given to just how unlikely this incredibly expensive treatment was to benefit her and whether it was even ethical to be doing such a study in which the patient bore over $200,000 of the cost for a treatment that was indeed experimental and being studied in an uncontrolled clinical trial. There are some very thorny medical, ethical, and financial issues there indeed.

Perhaps the reason Dr. Sampson’s post resonated with me was because it reminded me of a story that was extensively discussed last year, so much so that I saved the link to it. The story (Cancer Patients, Lost in a Maze of Uneven Care) appeared on the front page of the New York Times last summer. The article in question starts out by telling a truly sad story about a 35 year-old woman who, after giving birth, was diagnosed with Stage IV colon cancer as the human interest “hook” with which to represent what is described as a systemic problem with cancer care in this country:
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Posted in: Cancer, Medical Ethics, Science and Medicine, Science and the Media, Surgical Procedures

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The early detection of cancer and improved survival: More complicated than most people think

“Early detection of cancer saves lives.”

How many times have you heard this statement or something resembling it? It’s a common assumption (indeed, a seemingly common sense assumption) that detecting cancer early is always a good thing. Why wouldn’t it always be a good thing, after all? For many cancers, such as breast cancer and colon cancer, there’s little doubt tha early detection at the very least makes the job of treating the cancer easier. Also, the cancer is detected at an earlier stage almost by definition. But does earlier detection save lives? This question, as you might expect, depends upon the tumor, its biology, and the quality and cost of the screening modality used to detect the cancer. Indeed, it turns out that the question of whether early detection saves lives is a much more complicated question to answer than you probably think, a question that even many doctors have trouble with. It’s also a question that can be argued too far in the other direction. In other words, in the same way that boosters of early detection of various cancers may sometimes oversell the benefits of early detection, there is a contingent that takes a somewhat nihilistic view of the value of screening and argues that it doesn’t save lives.

A corrollary of the latter point is that some boosters of so-called “alternative” medicine take the complexity of evaluating the effect of early screening on cancer mortality and the known trend towards diagnosing earlier and earlier stage tumors as saying that our treatments for cancer are mostly worthless and that the only reason we are apparently doing better against cancer is because of early diagnosis of lesions that would never progress. Here is a typical such comment from a frequent commenter whose hyperbolic style will likely be immediately recognizable to regular readers here:

Most cancer goes away, or never progresses, even with NO medical treatment. Most people who get cancer never know it. At least in the past, before early diagnosis they never knew it.

Now many people are diagnosed and treated, and they never get sick or die from cancer. But this would have also been the case if they were never diagnosed or treated.

Maybe early diagnosis and treatment do save the lives of a small percentage of all who are treated. Maybe not. We don’t know.

As is so often the case with such simplistic black and white statements, there is a grain of truth buried under the absolutist statement but it’s buried so deep that it’s well-nigh unrecognizable. Because we see this sort of statement frequently, I thought it would be worthwhile to discuss some of the issues that make the reduction of mortality from cancer so difficult to achieve through screening. I will do this in two parts, although the next part may not necessarily appear next week
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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The Ethics of “CAM” Trials: Gonzo (Part VI)

Part V of this Blog argued that the NCCAM-sponsored trial of the “Gonzalez regimen” for cancer of the pancreas is unethical by numerous criteria.† To provide an illustration, it quoted a case history of one of the trial’s subjects, who had died in 2002.¹ It had been written by the subject’s friend, mathematician Susan Gurney. A similar story was told on ABC 20/20 in 2000, albeit not about a trial subject. Each of these cases demonstrates the wide breadth of Gonzalez’s quackery, as did his brush with the New York medical board during the 1990s.

This entry addresses some aspects of how those in charge of the trial failed in their duty to protect human subjects. By implication, it suggests what is necessary to prevent similar travesties in the future. It also addresses, to the small extent that the information exists, what appear to be the final ethical violations: first, that the trial will never be completed, thus having “expose[d] subjects to risks or inconvenience to no purpose.” Second, that Columbia University and the responsible investigators have no intention of explaining why.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Science and Medicine

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The North Carolina Board of Medical Examiners, Dr. Rashid Buttar, and protecting the public from practitioners of non-science-based medicine

One of the most contentious and difficult aspects of trying to improve medical care in this country is enforcing a minimal “standard of care.” Optimally, this standard of care should be based on science- and evidence-based medicine and act swiftly when a practitioner practices medicine that doesn’t meet even a minimal requirement for scientific studies and clinical trials to support it. At the same time, going too far in the other direction risks stifling innovation and the ability to individualize treatments to a patient’s unique situation–or even to use treatments that have only scientific plausibility going for them as a last-ditch effort to help a patient. Also, areas of medicine that are still unsettled and controversial could be especially difficult to adjudicate. Unfortunately, with medicine being regulated at the state level, there are 50 state medical boards, each with different laws governing licensure requirements and standards for disciplining wayward physicians, our current system doesn’t even do a very good job of protecting the public from physicians who practice obvious quackery. The reasons are myriad. Most medical boards are overburdened and underfunded. Consequently, until complaints are made and there is actual evidence of patient harm, they are often slow to act. Also, in my experience, they tend to prefer to go after physicians who misbehave in particularly egregious ways: alcoholic physicians or physicians suffering from other forms of substance abuse; physicians who sexually abuse patients; or physicians who are “prescription mills” for narcotics. These sorts of cases are often much more clear-cut, but most importantly they don’t force boards to make value judgments on the competence and practice of physicians to nearly the extent that prosecuting purveyors of unscientific medicine does.

Dr. Rashid Buttar: Autism and cancer

The reason I’ve been thinking about this issue again is because last Friday it was announced that one of the most dubious of dubious physicians of which I have ever become aware, Dr. Rashid Buttar of North Carolina, was, after many years of practice, finally disciplined by the North Carolina Board of Medical Examiners. Basically, the Board restricted his practice so that he could no longer treat children or cancer patients (more on why those two particular restrictions were imposed below). Once hailed as a hero by antivaccinationists and even once having testified to the Subcommittee on Wellness & Human Rights on autism issues, he is now disgraced.

Dr. Buttar runs a clinic called the Center for Advanced Medicine and Clinical Research, which features on its front page this quote:

“All truth passes through 3 phases: First, it is ridiculed. Second, it is violently opposed, and Third, it is accepted as self-evident.”- Arthur Schopenhauer, 1788-1860.

I can’t resist mentioning that any time I see this particular quote, I know that I’m almost certainly dealing with someone who is far on the fringe, because what one first has to realize about the quote is that non-”truth” never makes it past phase one or two–and rightly so. Right off the bat, we can see that Dr. Buttar has a greatly inflated view of his own importance.
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Posted in: Cancer, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Vaccines

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Barriers to practicing science-based surgery

ResearchBlogging.orgMuch to the relief of regular readers, I will now change topics from those of the last two weeks. Although fun and amusing (except to those who fall for them), continuing with such material for too long risks sending this blog too far in a direction that no one would want. So, instead, this week it’s time to get serious again.

A few weeks ago, I wrote about factors that lead to the premature adoption of surgical technologies and procedures or the “bandwagon” or “fad” effect among surgeons. By “premature,” I am referring to widespread adoption “in the trenches,” so to speak, of a procedure before good quality evidence from science and clinical trials show it to be superior in some way to previously used procedures, either in terms of efficacy, cost, time to recover, or other measurable parameters. As I pointed out before, laparoscopic cholecystectomy definitely fell into that category. The popularity of the procedure spread like wildfire in the early 1990s before there was any good quality data supporting its superiority to the “old-fashioned” gold standard procedure of open cholecystectomy. Another example, although not nearly as dramatic because the number of patients for whom the procedure would be appropriate is much smaller, is transanal endoscopic microsurgery. However, the difficulties in practicing science- and evidence-based medicine don’t just include fads and bandwagon effects. The example of laparoscopic cholecystectomy notwithstanding (which was largely driven by marketing and patient demand), surgical culture is deeply conservative in that it can be very reluctant to change practice even there is very strong evidence saying that they should.
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Posted in: Basic Science, Cancer, Surgical Procedures

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