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Yes We Can! We Can Abolish the NCCAM! Part II

Pseudoscience and Dishonesty, continued: “Reliable Information”?

In the previous post, we examined misrepresentations by the late National Center for Complementary and Alternative Medicine (NCCAM) Director Stephen Straus and Margaret Chesney, written in 2006 as a rebuttal to a critical article by Donald Marcus and Arthur Grollman in Science magazine. Here, we continue. According to Straus and Chesney:

Before the establishment of NCCAM, there was no central source of CAM information. NCCAM brings evidence-based information on CAM to the public, practitioners, and researchers. NCCAM disseminates research findings and provides reliable information about commonly used CAM practices through numerous channels, including…its award-winning Web site… NCCAM’s communications program deals with a field that is controversial, that has many critics, and that reaches a public that wants reliable information.

Before the establishment of the NCCAM, there was an excellent source of reliable information about “CAM”: Quackwatch. It continues to be the most comprehensive source of such information.

The NCCAM itself does not provide “reliable information about commonly used ‘CAM’ practices.” Rather, it bends over backward—in some instances making categorically false statements—to portray absurd, dangerous, implausible, or disproved practices as safer and more promising than they are.

Examples follow, but first please consider an implicit yet abundant and compelling piece of evidence that has left several of us (1, 2, 3) scratching our heads since the NCCAM began: each year the Center bestows numerous grants for the purpose of teaching “CAM” (not “CAM research”) to health professionals or for “integrating CAM” into various programs, or for establishing “integrative medicine” centers. For examples, look here. Isn’t this putting the cart before the horse? How can this be viewed as anything other than promoting “CAM”? Consider that Straus and Chesney also wrote:

In the early years of NCCAM, there was a sense of urgency to scientifically assess a range of CAM therapies that had been in long use by the public in the absence of proof of safety or efficacy.

In the subsequent 8 years, there has not been a burgeoning list of “CAM therapies” that have been proven safe and effective. The number of treatments that would qualify for that list, or for a comparable list before the creation of the NCCAM is, if you’ll excuse the rudeness of reliable information,…zero. In other words, the NCCAM admits that the treatments that characterize its “CAM integration” projects have not been shown safe and effective.

But back to a few explicit examples of unreliable information.

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Natural versus “natural” in CAMworld

“When I use a word,” Humpty Dumpty said in rather a scornful tone, “it means just what I choose it to mean — neither more nor less.”

“The question is,” said Alice, “whether you can make words mean so many different things.”

“The question is,” said Humpty Dumpty, “which is to be master— that’s all.”

From: Through the Looking Glass, and
What Alice Found There
by Lewis Carroll

“How can I help seeing what is in front of my eyes? Two and two are four.”

“Sometimes, Winston. Sometimes they are five. Sometimes they are three. Sometimes they are all of them at once. You must try harder. It is not easy to become sane.”

From: Nineteen Eighty-Four by George Orwell

One of the most powerful weapons in the armamentarium of advocates of the unscientific and implausible medical practices that fall under the rubric of “complementary and alternative medicine” (CAM) or, even worse, “integrative medicine” (IM), both of which seek to seamlessly “integrate” pseudoscience with science to the point that people start to be unable to tell which is which in order to “complement” effective medicine with placebo-based medicine, is their skill manupulating language. Wally Sampson has harped on this time and time again on this blog, particularly in his masterful fictional (but all too true-sounding) response to the question, “Why would medical schools associate with quackery?” Kimball Atwood has even turned the–shall we say?–”plasticity” with which CAM/IM advocates manipulate language to their advantage into humorous and all-too-infrequently recurring Friday feature. All of us have complained about how CAM/IM advocates have coopted diet and exercise as being somehow “alternative” and are now using that as the “foot in the door” to introduce pseudoscientific quackery like reiki and homeopathy into not just medical schools but to try to persuade the incoming Obama Administration to fund quackery on equal terms with scientific medicine as part of a “reform” designed to “promote health.”

Much of the success, both previous and current, of CAM/IM advocates depends upon language. Just like Humpty-Dumpty, to ideologues like Deepak Chopra, words mean just what they choose them to mean, and, just like the view forced on Winston Smith at the Ministry of Love, two plus two are sometimes five, no matter how much we know they are four. All it takes is viewing science as “just another narrative,” as postmodernist supporters of CAM/IM would like. Once that happens, there is nothing to stop one from viewing CAM/IM as being a “narrative” just as valid as that of science-based medicine. It’s the way “quackery” has been transformed into “unconventional,” later into “alternative,” and most recently “integrative” medicine. It’s all designed to play on the natural American desire to be “fair” and the media’s desire for “balance,” even though it is not fair to give pseudoscience a patina of scientific respectability that it does not deserve or use “balance” to present quackery as though it has equal standing with scientific medicine.

If there is one word that has been corrupted by the CAM/IM movement more than any other, my vote would go the world “natural.” Of course, it’s not just the CAM/IM movement that has molded this word to mean whatever meaning is required for whatever purpose is desired. For decades, the advertising industry has done the same. However, the CAM/IM movement takes it to a new level, or “kicks it up a notch,” as a certain TV chef likes to say.

I came across a perfect example of this in the form of a man named Tony Isaacs.
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Posted in: Cancer, Clinical Trials, Science and Medicine

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Our own slippery grounds

When we were forming the National Council against Health Fraud I wondered aloud to the president, Bill Jarvis, what we would do if society solved the chiropractic problem. Bill laughed and said there would never be an end to quackery claims.

How right he was. But why? Many express surprise that at this time of remarkable intellectual and scientific advance, so many people choose to believe in irrational medical claims. The answer I am used to is the one that explains the difference between the attraction of subjective versus the dryness of the objective; between reflex and conditioned responses and rational thought, and between immediate emotionally gratifying, low-level mid-brain reactions and slow-reacting, cool, higher level intellectual thought. These comparisons are all valid but in trying to answer the question, we can miss the constancy of human nature biology, the dimension of time flow, the changing nature of evidence, and as yet unemphasized, the changes and evolution of measurement.…

Before Evidence Based Medicine (EBM) was devised, and the randomized clinical trial (RCT) accepted as the so-called gold standard, our evidential decisions turned on balances or ratios of science/nonsense, rationality/irrationality, reality/delusion, and an estimate of plausibility/implausibility. We can see now that the concept of EBM introduced a new set of standards to our equations balances – proof by RCT and their derivatives, systematic reviews (SRs). The demand for proof by RCT and and SR relegated the previous standards, the unbalanced ratio concept, to the level of anecdote and “uncontrolled observation.” We had to start over again with a new standard.
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Posted in: Basic Science, Clinical Trials, Health Fraud, Science and Medicine

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Psychological support and breast cancer – again

Does the degree of efficacy is depend on the time at which it is measured? Apparently so. The case of psychological support and breast cancer longevity again.

After an original 1989 report of positive effects on metastatic breast cancer, by 2006- 7 the majority of RCTs on such effects had settled the issue in the negative. This was only after 20 years of repeated research grants and RCTs based on hunches and feelings that somehow emotional support really affected the course of cancer. Investigations continued despite analyses showing the few original positive studies had been so flawed in design or defective in reported details, that they should have been dismissed and perhaps excluded from systematic reviews. (Spiegel D, Bloom JR, Kraemer H, Gottheil E. Psychological support for cancer patients, Lancet ,1989 Dec 16;2(8677):1447., Fawzy FI, Fawzy NW, et al. Malignant melanoma. Effects of an early structured psychiatric intervention, coping, and affective state on recurrence an survival 6 years later. Arch Gen Psychiatry. 1993 Sep;50(9):681-9.)

But to advocates, conflicting results served as motive to prove the claims by repeating the studies for 20 years, “doing them right this time.” As of mid-2008, consensus was the issue was still “negative.” Now another study, claimed to be positive, makes the news.

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Posted in: Cancer, Clinical Trials, Science and Medicine, Science and the Media

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Do over one in five breast cancers detected by mammography alone really spontaneously regress?

ResearchBlogging.orgIt figures.

Last Wednesday, right before the four-day Thanksgiving holiday weekend, as I was far more interested in preparing to have family over the next day than in what was going on in the medical news or the blogs, the results of a most fascinating study hit the news. In Medscape, the title of the news report was Mammography Study Suggests Some Breast Cancer May Spontaneously Regress; on WebMD, the story ran under the title Can Breast Cancer Disappear?; on Medical News Today, Mammograms May Identify Cancers That Would Otherwise Just Regress by Drs. Per-Henrik Zahl, Jan Maehlen, and H. Gilbert Welch. Not surprisingly, the study found its way out of the medical news and into mainstream media outlets as well, given how provocative the findings seemingly are. From the Medscape report on this study:

A mammography study from Norway has come up with the controversial proposal that one fifth of breast cancer detected on screening may spontaneously regress. But there is no easy way to verify whether this is the case, say experts.

The study was published in the November 24 issue of the Archives of Internal Medicine. It found that the cumulative incidence of invasive breast cancer in a cohort of women, aged 50 to 64 years, who received 3 mammograms over 6 years was 22% higher than in a control group of age-matched women who received only 1 mammogram at the end of a 6-year period.

In their review of possible explanations for the difference in the breast cancer rates between the 2 groups — which had similar risk factors for breast cancer — the researchers write that the “natural course for some screen-detected breast cancers may be to spontaneously regress.”

“I anticipate that many clinicians will react negatively to the possibility of spontaneous regression, said coauthor Jan Maehlen, MD, PhD, professor of pathology at the Ulleval University Hospital, in Oslo, Norway, in an interview with Medscape Oncology.

Before I discuss the study itself, let me briefly discuss why clinicians may have a bit of a problem with the implications of this study, if they accurately reflect the biology of breast cancer.
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Science and the Media

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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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NCCAM: the not-even-wrong agency

The National Center for Complementary and Alternative Medicine (NCCAM) is a government agency tasked with (among other things), “[exploring] complementary and alternative healing practices in the context of rigorous science.” In this space we have talked about NCCAM quite a bit, but I have to admit that I don’t think about them very much. The other day, though, I was reading though JAMA and I came across a study funded by the agency. The study, which showed that Ginkgo does not prevent Alzheimer’s-type dementia, was pretty good, so I cruised on over to NCCAM’s website to see what else they’ve been up to.

A quick glance at NCCAM’s front page:

    “Ginkgo Evaluation of Memory (GEM) Study Fails To Show Benefit in Preventing Dementia in the Elderly”
    “CAM and Hepatitis C: A Focus on Herbal Supplements ‘No CAM treatment has yet been proven effective for treating hepatitis C or its complications.’”
    “Selenium and Vitamin E in Prostate Cancer Prevention Study, ‘selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer.’”

It seems that NCCAM is finding out something we already strongly suspected:  improbable medical claims are usually wrong.  Since that’s not how they see things,  and since I don’t believe that there is such a thing as alternative medicine, I was curious how they defined CAM.

CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Conventional medicine is medicine as practiced by holders of M.D. (medical doctor) or D.O. (doctor of osteopathy) degrees and by their allied health professionals, such as physical therapists, psychologists, and registered nurses. Some health care providers practice both CAM and conventional medicine. While some scientific evidence exists regarding some CAM therapies, for most there are key questions that are yet to be answered through well-designed scientific studies–questions such as whether these therapies are safe and whether they work for the diseases or medical conditions for which they are used.

The list of what is considered to be CAM changes continually, as those therapies that are proven to be safe and effective become adopted into conventional health care and as new approaches to health care emerge. emphasis mine, ed.

The list of NCCAM studies appears to fall into three broad categories.

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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine

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On the dangers of using valid placebo controls in clinical trials of acupuncture

ResearchBlogging.orgI don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to do with whether or not acupuncture did or did not have efficacy treating disease or other conditions. That was clearly a holdover from the pre-scientific medicine times in which most beliefs about the causes of disease involved either the wrath of the gods or vitalism, the latter of which is, when you come right down to it, the philosophical basis upon which many “complementary and alternative” (CAM) modalities are based, especially the so-called “energy healing” modalities, such as reiki, therapeutic touch, and, of course, acupuncture.

However, because unlike so many other “energy healing” methods, acupuncture involved an actual physical action upon the body, namely the insertion of thin needles into the skin to specified depths, it did not seem to me entirely unreasonable that there might be some sort of physiological effect that might produce a therapeutic result. At least, that’s what I used to think until I actually started paying attention to the scientific literature on acupuncture. That’s when I started to realize that “there’s no ‘there’ there,” if you know what I mean. Horribly designed studies with either no controls or utterly inadequate controls tend to be the norm in the acupuncture “literature” (if you can call it that). Moreover, acupuncture was touted as having value for conditions and procedures for which there is no plausible (or even mildly plausible) physiological mechanism by which it could be reasonably postulated to have an effect. Arthritis, allergies, headache, back pain, gastroesophageal reflux disease (GERD), Parkinson’s disease, post-operative nausea, hot flashes in breast cancer patients caused by the anti-estrogen drugs they have to take, infertility, it doesn’t matter. Seemingly acupuncture can do it all; it’s the Swiss Army knife of CAM therapies. Moreover, the “explanations” given to explain “how acupuncture works” seemed increasingly less plausible to me. Most of these explanations involve counterirritation or the release of opioids, and I’ve had an increasingly hard time believing that, even if these mechanisms are at play, they could have anything other than nonspecific effects, with no mechanism to explain how acupuncture could possibly do all things attributed to it. One rule of medical skepticism is that you should be very skeptical of modalities that are touted to be useful for a wide variety of medical conditions that have very different pathophysiology. Indeed, a funny thing happens when rigorous placebo controls are introduced, and that’s sometimes the placebo control does better than the “true” acupuncture; i.e., the evidence for acupuncture, taken in its totality, is completely compatible with placebo effect.

As Harriet Hall put it in her excellent analysis of a study purporting to show that acupuncture is useful for GERD:

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

One area that acupuncturists keep needling away at is infertility. Somehow, in the CAM community it’s become conventional wisdom that acupuncture can somehow increase the chance of success for couples undergoing in vitro fertilization (IVF). Indeed, early this year I wrote about a meta-analysis that concluded that acupuncture did actually increase the success rate of IVF and why it did not show what its authors thought it showed. Tooth fairy science, indeed.

Now comes yet another study being publicized in the media that examines once again the question of whether sticking needles into women before they undergo IVF can increase their chances of conceiving. I could not help but be extremely amused by the title given to the ScienceDaily story about it: Placebo Acupuncture Is Associated With Higher Pregnancy Rate After IVF Than Real Acupuncture. You have to love a headline like that, and opening paragraphs like this:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

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Vitamin Cocktail with a Meme Twist (Supplement my gimlet with a dash of dissonance)

A trail of recent reports is trying to tell us something. But are we listening, and are “they” listening? If so, does it mean the same to “them” as it does to us?

The report trail is telling us that multiple vitamins fail as preventatives against cardiovascular disease, cancer, or even for anything other than for dietary vitamin deficiency. And that is what we were saying in the first place – forty and more years ago.

Here is a partial list of these recent reports –  followed by an odd turn

Vitamins E and C were ineffective in preventing `cardiovascular disease in men. Sesso HD, Buring JE, Christen WG et al. JAMA, 2008;300 (Physicians’ Health Study II, mong 14,641 male physicians. [...] The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.

B Vitamins (B12, B6, folate) May Not Reduce Cardiovascular Events For Coronary Artery Disease Patients Ebbing M, et al, JAMA 2008, Aug 20 — In a large clinical trial involving patients with coronary artery disease, use of B vitamins B6, B12, folate was not effective for preventing death or cardiovascular events. Patients were randomly assigned to one of four groups receiving a daily oral dose of one of the following treatments: folic acid, 0.8mg, plus vitamin B12 , 0.4mg, plus vitamin B6 , 40mg (n= 772); folic acid plus vitamin B12 (n = 772); vitamin B6 alone (n = 772); or placebo (n = 780).The study was stopped early because of concerns among the participants about preliminary results from another similar Norwegian study suggesting no benefits from the treatment and an increased risk of cancer from the B vitamins. Daily supplementation combination that included folic acid and vitamin B6 and B12 had no significant effect on the overall risk of cancer, including breast cancer, among women at high risk of cardiovascular disease. Zhang M et al, JAMA 2008 Nov. 5.

Certain Vitamin Supplements May Increase Lung Cancer Risk, Especially In Smokers. November 11, 2008, from American Thoracic Society. March of the American Thoracic Society’s American Journal of Respiratory and Critical Care Medicine.

Selenium and vitamin E supplements, taken either alone or together, did not prevent prostate cancer; these results came from initial, independent review of study data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute. (publication  Feb. 1 in the Journal of Clinical Oncology.)

These reports, along with those showing inefficacy of vitamin E in CV prevention and others, all in recent months, dovetail on more reported over the past decade. Now for the dissonance. A popular Web portal posted a brief questionnaire following one of last week’s reports. It asked readers to answer if they took vitamins regularly, infrequently, or not at all.
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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Nutrition, Politics and Regulation

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Statins Are Better on JUPITER

Over 26 million Americans are taking statin drugs. Some people think they should be available over-the-counter without a prescription, and it has even been facetiously suggested that they should be added to our drinking water. The protective effect of statins in cardiovascular disease and in high-risk patients with high cholesterol levels is well established. But what about people with no heart disease and normal cholesterol levels – can they benefit too?

The New England Journal of Medicine has pre-released an important new study on statins online prior to its planned publication date of November 20, 2008. It is certain to stir up a lot of controversy, and the International Network of Cholesterol Skeptics will not be happy, because it contradicts some of their favorite arguments. They have claimed that statins do more harm than good, that reducing cholesterol levels is harmful to health, that the benefits of statins and/or cholesterol lowering do not extend to women and the elderly, and that studies showing benefits of statins are meaningless because they do not show reduction of overall mortality. This study indicates otherwise. (more…)

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