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Is the Ebola Crisis a Reason to Skip RCTs?

Ebola virus

 

In a recent “Perspective” article in The New England Journal of Medicine, three physicians (Drs. Cox, Borio, and Temple) make a strong case for not letting the rush to save Ebola patients tempt us to deviate from good science and skip the randomized controlled trial (RCT). Their arguments cut to the essence of the scientific approach to medicine, and they deserve careful consideration.

Ebola is uniquely scary

Ebola is the kind of threat that really gets our attention. The virus was first identified in 1976, and prior to 2013 there were several small outbreaks in Africa with death rates as high as 90%. This time the death rates are lower, but the numbers are much greater. It has spread to several African countries, and a few cases have even reached the US and Europe due to infected travelers and health care workers. We face a risk that Ebola may become endemic, smoldering along as a constant presence in Africa.

There is no known effective treatment. Fear of Ebola has sparked bizarre conspiracy theories and claims of “natural” cures and prevention kits from homeopaths, alternative medicine advocates like Mercola, and purveyors of remedies like colloidal silver and essential oils. These have been covered on SBM here, here, and here. (more…)

Posted in: Clinical Trials, Science and Medicine

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Acupuncture for Withdrawal Symptoms in Critically Ill Infants

weebleswobble

Like acupuncture, Weebles wobble, but they don’t fall down.

The practice of medicine, particularly our pharmaceutical and surgical interventions, involves a constant struggle between risk and benefit. If the physiology or anatomy of the human body is altered, even with the best of intentions, there is always a potential downside. There are certainly instances where the risk to benefit ratio is extremely favorable or unfavorable and the right recommendation is obvious, and unfortunately there are times when it isn’t entirely obvious what the next step should be. But there has been a trend of steady progress in regards to improved safety and efficacy over the past several decades.

The treatment of pain has of late been one of those areas where the picture is becoming a bit less cloudy. We are learning more and more about the potential negative outcomes related to the long term use of opioid medications, such as physical dependence, addiction and even chronic pain. The way that these drugs have been prescribed in many patients has caused more harm than expected, and in some instances more hurt than help. Doctors generally strive to alleviate pain and suffering but, once again, good intentions don’t decrease risk.

In the neonatal and young infant population, the management of pain has had a rocky history. I’ve written about pediatric pain in the past, in particular the potential difficulties in managing acute pain. I won’t go into detail (read my prior post), but we have truly come a long way since the days of performing major surgery on newborns without any analgesia at all. There are areas where we need to do better, however. Children are still less likely than adults to be adequately treated for pain.

But things have improved. And as more children receive appropriate management for pain, the side effects of that management must increasingly be dealt with by healthcare professionals, the patients and their families. One of the issues that is typically observed and managed in neonatal and pediatric intensive care units is physical dependence and the subsequent occurrence of withdrawal symptoms.
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Posted in: Clinical Trials

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Stem cells versus Gordie Howe’s stroke, part 2

Gordie-Howe

Another Christmas has come and gone, surprisingly fast, as always. I had thought that it might make a good “last of 2014″ post—well, last of 2014 for me, anyway; Harriet and Steve, at least, will be posting before 2014 ends—to do an end of year list of the best and worst of the year. Unfortunately, there remains a pressing issue that doesn’t permit that, some unfinished business, if you will. I’m referring to a story I commented on last week, specifically the credulously-reported story of how 86-year-old hockey legend Gordie Howe is doing a lot better after having undergone an experimental stem cell therapy for his recent stroke. As you might recall at the time, I saw a lot of holes in the story. It turns out that over the last week there have been developments that allow me to fill in some of those holes. Unfortunately, other holes still remain.

First, a brief recap is in order (You can click here for a more detailed timeline). Gordie Howe suffered a massive stroke on October 26, leaving him hemiplegic and with serious speech impairment. Since then, judging from various media reports, he has been slowly improving, although not without significant setbacks. We also know that Howe suffers from significant dementia. Out of the blue, a press release issued on December 19 by the Howe family announced that on December 8 and 9, Gordie Howe “underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2.” His response was described as “truly miraculous,” although, as I pointed out in my post, it’s not clear exactly what “miraculous” meant, given conflicting contemporaneous news accounts before the Howe family press release, particularly his hospitalization from December 1 to 3 for a suspected stroke that turned out to be dehydration.

I noted a number of problems with the story, the first of which is that Howe was clearly not eligible for the clinical trial offered by Stemedica, a company in San Diego that manufactured the stem cells used. Another glaring issue was my inability to locate any description of an actual clinical trial for stroke offered by Novastem. I could find no such trial listed in ClinicalTrials.gov, and you, our intrepid readers, searched the registry maintained by the Mexican Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and were not able to find any registered clinical trials for stroke being carried out by Clínica Santa Clarita, the clinic Novastem operates. What you, our intrepid readers, did find were trials of stem cells for:

I did the search again over the weekend, and there were no further trials that I could find.
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Posted in: Clinical Trials, Medical Ethics, Science and the Media

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Stem cells versus Gordie Howe’s stroke

GordieHowe1

Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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Study of “Acupressure” for Constipation

constipationA recent study in the Journal of General Internal Medicine evaluated a treatment for constipation. It tested whether training patients to massage the perineum (the area between the vagina or scrotum and the anus) would improve their reported bowel function and quality of life at 4 weeks after training. They found that it did. It’s a simple, innocuous treatment that may be worth trying, but why, oh why, did they have to call it “acupressure”? That irritated me. Should it have? Why should it matter? Isn’t a rose by any other name still a rose? Is this a meaningless semantic quibble and hypersensitivity on my part, or am I right to see it as yet another example of quackademia’s attempts to infiltrate science-based medicine? I’ll explain my thinking and let you decide for yourself. (more…)

Posted in: Acupuncture, Clinical Trials, Traditional Chinese Medicine

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Selling “integrative oncology” as a monograph in JNCI

pancreatic-cancer-diagnostics-l

Sometimes, it’s hard not to get the feeling that my fellow bloggers at Science-Based Medicine and I are trying to hold back the tide in terms the infiltration of pseudoscience and quackery into conventional medicine, a term I like to refer to as quackademic medicine. In most cases, this infiltration occurs under the rubric of “complementary and alternative medicine” (CAM), which these days is increasingly referred to as “integrative medicine,” the better to banish any impression of inferior status implied by the name “CAM” and replace it with the implication of a happy, harmonious “integration” of the “best of both worlds.” (As I like to point out, analogies to another “best of both worlds” are hard to resist.) Of course, as my good buddy Mark Crislip has put it, the passionate protestations of CAM advocates otherwise notwithstanding, integrating cow pie with apple pie doesn’t make the cow pie better. Rather, it makes the apple pie worse.

In any case, over the last three months, Steve Novella and I published a solid commentary in Trends in Molecular Medicine decrying the testing in randomized clinical trials of, in essence, magic, while I managed to score a commentary in Nature Reviews Cancer criticizing “integrative oncology.” Pretty good, right? What do I see this month in the Journal of the National Cancer Institute (or JNCI, as we like to call it)? An entire monograph devoted to a the topic, “The Role of Integrative Oncology for Cancer Survivorship”, touting integrative oncology, of course. And where did I find out about this monograph? I found out about it from Josephine Briggs, the director of the National Center for Complementary and Alternative Medicine (NCCAM) herself, on the NCCAM blog in a post entitled “The Evidence Base for Integrative Approaches to Cancer Care“, in which she touts her perspective piece in the JNCI issue entitled “Building the Evidence Base for Integrative Approaches to Care of Cancer Survivors.” In an introductory article, Jun J. Mao and Lorenzo Cohen of the Department of Family Medicine and Community Health, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania and the University of Texas M.D. Anderson Cancer Center, respectively, line up this monograph thusly:
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Posted in: Cancer, Clinical Trials, Medical Academia

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Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Be less curious about people and more curious about ideas.
– Marie Curie’s advice to journalists

langer cbs this

Harvard psychologist Ellen Langer was on CBS This Morning News explaining plans for a psychosocial intervention study with women with Stage IV metastatic breast cancer. The project would attempt to shrink women’s tumors by shifting their mental perspective back to before they were diagnosed.
Seeing her on TV unsettled me because I had just supplied a journalist with quotes for his article in the New York Times about Langer. I hadn’t been following her recently. Instead I focused on her now-famous study from the 70s. Langer had claimed that giving nursing home residents a plant for which they were responsible cut their mortality by half (the nursing home residents, not the plant), compared to residents whose plants were attended by staff. The paper continues to get uncritical coverage in the media and in introductory psychology texts.

I looked up the Timesarticle after seeing CBS This Morning News, and it accurately quoted me:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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Retconning the story of traditional Chinese medicine

Retcon

Retcon (shortened form of RETroactive CONtinuity; first made popular in the comic book world):

  1. (original meaning) Adding information to the back story of a fictional character or world, without invalidating that which had gone before.
  2. (more common usage) Adding or altering information regarding the back story of a fictional character or world, regardless of whether the change contradicts what was said before.

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Posted in: Clinical Trials, History, Medical Academia, Traditional Chinese Medicine

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Conspiracy theories and Ebola virus transmission

Yesterday, I spiffed up a post that some of you might have seen, describing how a particular medical conspiracy theory has dire consequences in terms of promoting non-science-based medical policy. Specifically, I referred to how the myth that there are all sorts of “cures” for deadly and even terminal diseases that are being kept from you by an overweening fascistic FDA’s insistence on its approval process is an important driving force behind ill-advised “right to try” legislation that’s passed in four states and likely to pass in Arizona by referendum tomorrow. I’m not exaggerating, either. If you have the stomach to delve into the deeper, darker recesses of alternative medicine and conspiracy theory websites, you’ll find words far worse than that used to describe the FDA, such as this little gem from everyone’s favorite über-quack Mike Adams basically portraying the FDA as Adolf Hitler. Even more “mainstream” advocates, such as Reason.com’s Ronald Bailey and Nick Gillespie, are not above using a version of this myth stripped of the worst of its conspiracy mongering for public consumption, claiming that the FDA is killing you.

Unfortunately, this sort of medical conspiracy theory is very common. Like all conspiracy theories, medical conspiracy theories tend to involve “someone” hiding something from the public. I like to refer to this as the fallacy of “secret knowledge.” That “someone” hiding the “secret knowledge” is usually the government, big pharma, or other ill-defined nefarious forces. The “secret knowledge” being hidden comes invariably in one of two flavors. Either “they” are hiding cures for all sorts of diseases that conventional medicine can’t cure, or “they” are hiding evidence of harm due to something in medicine. Although examples of the former are common, such as the “hidden cure for cancer,” it is examples of the latter that seem to be even more common, in particular the myth that vaccines cause autism and all sorts of diseases and conditions, that genetically modified organisms (GMOs) are dangerous, or that radiation from cell phones causes cancer. In these latter examples, invariably the motivation is either financial (big pharma profits), ideological (control, although descriptions of how hiding this knowledge results in control are often sketchy at best), or even some seriously out there claims, such as the sometimes invoked story about how mass vaccination programs are about “population control” or even “depopulation.” Either way, “The Truth” needs to be hidden from the population, lest they panic and revolt.
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Posted in: Basic Science, Clinical Trials, Public Health

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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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