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On the “individualization” of treatments in “alternative medicine”

One of the claims most frequently made by “alternative medicine” advocates regarding why alt-med is supposedly superior (or at least equal) to “conventional” medicine and should not be dismissed, regardless of how scientifically improbable any individual alt-med modality may be, is that the treatments are, if you believe many of the practitioners touting them, highly “individualized.” In other words, the “entire patient” is taken into account with what is frequently referred to as a “holistic approach” that looks at “every aspect” of the patient, with the result that every patient requires a different treatment, sometimes even for the exact same disease of very close to the same severity. Indeed, as I have described before, a variant of this claim, often laden with meaningless pseudoscientific babble about “emergent systems,” is sometimes used to claim that the standard methods of science- and evidence-based medicine are not appropriate to studying the efficacy of alternative medicine. Of course, this is, in nearly all cases, simply an excuse to dismiss scientific studies that fail to find efficacy for various “alt-med” modalities, but, even so, it is a claim that irritates me to no end, because it is so clearly nonsense. As Harriet Hall pointed out, alt-med “practitioners” frequently ascribe One True Cause to All Disease, which is about as far from “individualization” as you can get, when you come right down to it. More on that later.

A couple of years ago, before I became involved with this blog, I was surprised to learn that even some advocates of alt-med have their doubts that “individualization” is such a great strength. I had never realized that this might be the case until I came across a post by naturopath Travis Elliott, who runs a pro-alt-med blog, Dr. Travis Elliott and the Two-Sided Coin, entitled The Single Most Frustrating Thing About (Most) Alternative Medicine. In this article, Elliott referred to a case written up by a fellow naturopath, who used an anecdote about the evaluation and treatment plan by a naturopath of a pregnant woman with nausea to show what is supposedly the “unique power of our medicine.” Unexpectedly (to me at least at the time), Elliott did not quite see it that way:
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Posted in: Clinical Trials, Energy Medicine, Homeopathy, Science and Medicine

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The life cycle of translational research

ResearchBlogging.orgI’m a translational researcher. To those of you who aren’t familiar with what that means, it means (I hope) that I study potential therapies in the lab and try to translate them into actual therapies that will cure patients of breast cancer — or, at the very least, improve their odds of survival or prolong survival when cure is not possible. Translational research is extremely important; indeed, it is the life blood of science-based medicine, with basic science producing the discoveries and clinical research the applications of these discoveries. When it works, it’s the way that science leads medicine to advance. However, sometimes I think that it’s a bit oversold. For one thing, it’s not easy, and it’s not always obvious what basic science findings can be translated into useful therapies, be it for cancer (my specialty) or any other disease. For another thing, it takes a long time. The problem is that the hype about how much we as a nation invest in translational research all too often leads to a not unreasonable expectation that there will be a rapid return on that investment. Such an expectation is often not realized, at least not as fast and frequently as we would like, and the reason has little to do with the quality of the science being funded. It has arguably more to do with how long it takes for a basic science observation to follow the long and winding road to producing a viable therapy. But how long is that long and winding road?

A lot longer than many, even many scientists, realize. At least, that’s the case if a paper from about a year ago by John Ioannidis in Science is any indication. The article appeared in the Policy Forum in the September 5 issue and is entitled Life Cycle of Translational Research for Medical Interventions. As you may recall, Dr. Ioannidis made a name for himself a couple of years ago by publishing a pair of articles provocatively entitled Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False, which Steve Novella blogged about a couple of years ago.

Dr. Ioannidis lays it out right in the first paragraph:
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Posted in: Clinical Trials, Science and Medicine

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Acupuncture, the P-Value Fallacy, and Honesty

Credibility alert: the following post contains assertions and speculations by yours truly that are subject to, er, different interpretations by those who actually know what the hell they’re talking about when it comes to statistics. With hat in hand, I thank reader BKsea for calling attention to some of them. I have changed some of the wording—competently, I hope—so as not to poison the minds of less wary readers, but my original faux pas are immortalized in BKsea’s comment.

Lies, Damned Lies, and…

A few days ago my colleague, Dr. Harriet Hall, posted an article about acupuncture treatment for chronic prostatitis/chronic pelvic pain syndrome. She discussed a study that had been performed in Malaysia and reported in the American Journal of Medicine. According to the investigators,

After 10 weeks of treatment, acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms. Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture.

The primary endpoint was to be “a 6-point decrease in NIH-CSPI total score from baseline to week 10.” At week 10, 32 of 44 subjects (73%) in the acupuncture group had experienced such a decrease, compared to 21 of 45 subjects (47%) in the sham acupuncture group. Although the authors didn’t report these statistics per se, a simple “two-proportion Z-test” (Minitab) yields the following:

Sample X   N   Sample p

1            32  44   0.727273

2           21  45   0.466667

Difference = p (1) – p (2)

Estimate for difference: 0.260606

95% CI for difference: (0.0642303, 0.456982)

Test for difference = 0 (vs not = 0): Z = 2.60 P-Value = 0.009

Fisher’s exact test: P-Value = 0.017

Wow! A P-value of 0.009! That’s some serious statistical significance. Even Fisher’s more conservative “exact test” is substantially less than the 0.05 that we’ve come to associate with “rejecting the null hypothesis,” which in this case is that there was no difference in the proportion of subjects who had experienced a 6-point decrease in NIH-CSPI scores at 10 weeks. Surely there is a big difference between getting “real” acupuncture and getting sham acupuncture if you’ve got chronic prostatitis/chronic pelvic pain syndrome, and this study proves it!

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Posted in: Acupuncture, Clinical Trials, Science and Medicine

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Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women?

A while back I wrote about rethinking how we screen for breast cancer using mammography. Basically, the USPSTF, an independent panel of physicians and health experts that makes nonbinding recommendations for the government on various health issues, reevaluated the evidence for routine screening mammography and concluded that for women at normal risk for breast cancer, mammography before age 50 should not be recommended routinely and should be ordered on an individualized basis, and that routine formalized breast self-examination (BSE) should also not be routinely recommended. In addition, for women over 50, it was recommended that they undergo mammography every other year, rather than every year. These recommendations were based on a review of the literature, including newer studies.

To say that these new recommendations caused a firestorm in the breast cancer world is an understatement. The USPSTF was accused of misogyny; opponents of health care reform leapt on them as evidence that President Obama really is preparing “death panels”; and HHS secretary Kathleen Sebelius couldn’t run away from the guidelines fast enough. Meanwhile, a society I belong to (the American Society of Breast Surgeons) issued a press release accusing the USPSTF of sending us back to the “pre-mammography” days when, presumably women only found breast cancer after it had grown to huge size (just like Europe and Canada, I guess, given that the recommendations for screening there closely mirrors those recommended by the USPSTF). Meanwhile, in the most blatant example of protecting its turf I’ve seen in a very long time, the American College of Radiology went full mental jacket with a press release that was as biased as it was insulting. Meanwhile some physicians even likened the recommendations to going back to being like Africa, Southeast Asia and China as far as breast screening goes in that he actually speculated that he’d now become very busy treating advanced, neglected breast cancers. Unfortunately, as Val pointed out, the communication of the USPSTF guidelines to the public was almost a perfect case study in how not to do it. Even though the science was in general sound and the USPSTF recommendations were in essence close to identical to what other industrialized nations do, they were communicated in just such a way as to produce maximum misunderstanding and misuse for political purposes.

Despite all the hysterical and in some cases disingenuous attacks on the new guidelines, there is one criticism that actually resonates with me because I work at a cancer center in a very urban environment with a large population of African-American women. Last week I heard on NPR this story:
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Public Health

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

ResearchBlogging.orgIt’s been about a year and a half since I’ve written about this topic; so I thought I’d better update the disclaimer that I wrote at the beginning:

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.
  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.

There. That’s better. Hopefully that will, as it did last time, serve as a shield against the “shill” argument, which is among the frequent accusations I hear whenever I venture into this particular topic area. So, as I did back in 2008, I just thought I’d clear that up right away in order (hopefully) to preempt any similar comments after this post. Unfortunately, as I have known for a long time, 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, either here or elsewhere. Posting such disclaimers never seems to work against the “pharma shill” gambit when I write about vaccines or dubious cancer cures. Even so, even after nearly ten years involved in skepticism and promoting science-based medicine, hope still springs eternal.

There are two reasons that I think the issue of mobile phones and cancer needs an update on our blog: First, it has been a year and a half since I last wrote about it. At that time I castigated Dr. Ronald B. Herberman, who at that time was director of the University of Pittsburgh Cancer Institute for what I viewed as fear mongering over cell phones and cancer based on at best flimsy evidence. Second, there have been two fairly high profile studies looking at whether there is a link between mobile phone use and cancer. One of these our fearless leader Steve Novella has already discussed, but there was another one that he didn’t see because it didn’t get quite as much publicity, possibly because the corresponding author is based in Korea. I will take this opportunity to discuss them both.
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Posted in: Cancer, Clinical Trials, Public Health

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Yet another nail in the coffin of the myth that the MMR vaccine causes autism

Arguably, the genesis of the most recent iteration of the anti-vaccine movement dates back to 1998, when a remarkably incompetent researcher named Andrew Wakefield published a trial lawyer-funded “study” in the Lancet that purported to find a link between “autistic enterocolitis” and measles vaccination with the measles-mumps-rubella (MMR) trivalent vaccine. In the wake of that publication was born a scare over the MMR that persists to this day, 11 years later. Although peer reviewers forced the actual contents of the paper to be more circumspect, in the press Wakefield promoted the idea that the MMR vaccine either predisposes, causes, or triggers autistic regressions. Even though over the next several years, investigations by investigative journalist Brian Deer revealed that not only was Wakefield’s research funded by trial lawyers looking to sue vaccine manufacturers for “vaccine injury” when he did his research (for which he is now being charged by the U.K.’s General Medical Council with scientific misconduct), but during the Autism Omnibus trial testimony by a world-renowed expert in PCR technology showed that he was incompetent. Even worse for Wakefield, in February 2009 Brian Deer published a news expose based on strong evidence that Wakefield may very well have falsified data for his Lancet paper.

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.
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Posted in: Clinical Trials, Vaccines

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Neti pots – Ancient Ayurvedic Treatment Validated by Scientific Evidence

Nasal irrigation with salt water is recommended by 87% of family doctors as an adjunctive treatment to relieve the symptoms of nasal congestion and sinusitis. The simplest method is to hold salt water in your cupped hand, block one nostril while you inhale the water into the other nostril, then blow your nose. The high-tech version is to use a Neti pot, a little jug with a spout. You pour the salt solution from the Neti pot into one nostril and it drains out the other nostril. The technique is described here.  Neti pot

The Neti pot originated in India in Ayurvedic medicine. Neti is Sanskrit for “nasal cleansing.” Other related ancient techniques that have not been adopted by scientific medicine include using a string instead of water and a yoga technique where you close one nostril, pour the solution into the other nostril and allow it to run out of the mouth. 

Nasal irrigation provides short-term symptomatic relief and may improve nasal mucociliary clearance. It removes mucus not only from the nose but also from the maxillary and ethmoid sinuses.   (more…)

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Cancer prevention: The forgotten stepchild of cancer research?

The New York Times has been periodically running a series about the “40 years’ war” on cancer, with most articles by Gina Kolata. I’ve touched on this series before, liking some parts of it, while others not so much. In particular, I criticized an article one article that I thought to be so misguided about how the NIH grant system leads researchers to “play it safe” and how we could cure cancer if we could just fund “riskier” research that I had to write an extended screed about the misconceptions in the article. The latest installment, Medicines to Deter Some Cancers Are Not Taken, also by Kolata, is much better in that it discusses a problem at the heart of cancer, namely that we have developed drugs that can decrease the risk of specific cancers but they are not as widely used as they could be.

The first part of the article contrasts a seeming incongruity:

Many Americans do not think twice about taking medicines to prevent heart disease and stroke. But cancer is different. Much of what Americans do in the name of warding off cancer has not been shown to matter, and some things are actually harmful. Yet the few medicines proved to deter cancer are widely ignored.

Take prostate cancer, the second-most commonly diagnosed cancer in the United States, surpassed only by easily treated skin cancers. More than 192,000 cases of it will be diagnosed this year, and more than 27,000 men will die from it.

And, it turns out, there is a way to prevent many cases of prostate cancer. A large and rigorous study found that a generic drug, finasteride, costing about $2 a day, could prevent as many as 50,000 cases each year. Another study found that finasteride’s close cousin, dutasteride, about $3.50 a day, has the same effect.

This is indeed a contrast. Think about it. Millions of Americans take statins, for instance, to lower their cholesterol and thereby try to prevent the complications of elevated cholesterol, such as heart disease, vascular disease, and strokes. Yet, for at least two common cancers, there are proven effective drugs that will lower the risk of cancer considerably with a side effect profile at least as favorable as that of statins.
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Posted in: Cancer, Clinical Trials, Herbs & Supplements, Nutrition, Politics and Regulation

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Conflicts of interest in science-based medicine

The topic of conflicts of interest among medical researchers has recently bubbled up to the public consciousness more than usual. The catalyst for this most recent round of criticism by the press and navel-gazing by researchers is the investigation of Senator Charles Grassley (R-IA) of nine psychiatric researchers, one of which held $6 million in stock in a company formed to bring a drug for depression to market, but had allegedly concealed this, even though he was an investigator on an NIH grant to study the drug he was developing. From my perspective, there is more than a little politics going on in this story, given that for the last decade federal law, specifically the Bayh-Dole Act, and policy have actually encouraged investigators and universities to co-develop drugs and treatments with industry, but it does bring into focus the issue of conflicts of interest, in particular undisclosed conflicts of interest. There are two articles of note that recently appeared in the scientific literature discussing this issue, one in Science in July (about the Grassley investigation) and an editorial in the Journal of Psychiatry and Neuroscience by Simon N. Young, PhD, the Co-Editor-in-Chief of the journal and faculty at McGill University. I was more interested in the latter article because it takes a much braoder view of the issue. Science-based medicine (SBM) depends upon the integrity of the science being done to justify treatments; so it’s useful to discuss how conflicts of interest intersect medical research.

In most public discussions of conflicts of interest (COIs), Young notes, the primary focus is on payments by pharmaceutical companies to investigators. Make no mistake, this is a big issue, but COIs are not just payments from drug companies. Indeed, I’ve written about just such COIs that have arguably impacted patient care negatively right her on this very blog, for example seeding trials (in which clinical trials are designed by the marketing division of pharmaceutical companies), a case of fraud that appeared to have been motivated by COIs. What needs to be understood is that every single scientific and medical investigators have COIs of one sort or another, and many are not financial. That’s why I like Young’s introduction to what COIs are:
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation, Vaccines

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A Case Study In Aggressive Quackery Marketing

With some degree of sadness I recently “outed” a former co-resident of mine who has turned to the dark side and begun putting money-making before truth and science. Without any clear evidence of benefit beyond placebo, platelet-rich plasma (PRP) is now being marketed aggressively as a cure-all for sports injuries. And at about $300 per injection (the NYT reports $2000/treatment), there’s plenty of money to be made.

Like the fake “stem cell” clinics in Russia (where, according to Sanjay Gupta’s recent book, Chasing Life, a person’s fat cells are harvested, washed, and re-injected into their blood stream), PRP also involves injection of autologous body fluids. Essentially, a small amount of blood is drawn from the patient, centrifuged, and the plasma supernatant is then injected directly into tendons and/or joints. After a series of 3 injections (one/month), most sports injuries are “cured.” Of course, most injuries would heal themselves in three months anyway. (more…)

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