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Archive for Clinical Trials

Chiropractors, Blind Pigs, and Acorns

Sometimes you need to help the blind pig.

Sometimes you need to help the blind pig.

When people are at the end of their life they like to pass on their life lessons. One thing I have never had a patient say is “Doc, I sure wish I had spent more time at work.”

I try and keep that in mind, but then there are those work commitments that are hard to avoid. I need to have a talk with Drs. Gorski and Novella. No one should have write a blog entry any week their team is in the play-offs. The Blazers were not meant to win more than 25 games, much less be the 5th seed in the West with a chance to make the conference finals. I know. Trailblazers fans are not always grounded in reality. But we are up on the Clippers 3–2 and heading home to close out the series tonight. For the record I wrote the preceding sentence during the game 5 tip-off. I really should not have to do any work this week. Basketball is simply more important.

Take this case report. Anywhere else.

Case reports are a tradition in medicine. Usually they are unique or unusual cases, diseases you are likely to see but once in a career, if that. There are all sorts of medical curiosities that need to be reported. I have a blog over at Medscape devoted to Infectious Disease case reports.

Some case reports, however, inspire eye rolls and sniggers. Why are these even reported? (more…)

Posted in: Chiropractic, Clinical Trials, Humor

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Acupuncture does not work for menopause: A tale of two acupuncture studies

Women looking for relief from hot flashes will be disappointed if they think acupuncture will help them.

Women looking for relief from hot flashes will be disappointed if they think acupuncture will help them.

Arguably, one of the most popular forms of so-called “complementary and alternative medicine” (CAM) being “integrated” with real medicine by those who label their specialty “integrative medicine” is acupuncture. It’s particularly popular in academic medical centers as a subject of what I like to refer to as “quackademic medicine“; that is, the study of pseudoscience and quackery as though it were real medicine. Consider this. It’s very difficult to find academic medical centers that will proclaim that they offer, for example, The One Quackery To Rule Them All (homeopathy). True, a lot of integrative medicine programs at academic medical centers do offer homeopathy. They just don’t do it directly or mention it on their websites. Instead, they offer naturopathy, and, as I’ve discussed several times, homeopathy is an integral—nay, required—part of naturopathy. (After graduation from naturopathy school, freshly minted naturopaths are even tested on homeopathy when they take the NPLEX, the naturopathic licensing examination.) Personally, I find this unwillingness of academic medical centers that offer naturopathy to admit to offering homeopathy somewhat promising, as it tells me that even at quackademic medical centers there are still CAM modalities too quacky for them to want to be openly associated with. That optimism rapidly fades when I contemplate what a hodge-podge of quackery naturopathy is and how many academic integrative medicine programs offer it.

If you believe acupuncturists, acupuncture can be used to treat almost anything. Anyone with a reasonable grasp of critical thinking should recognize that a claim that an intervention, whatever it is, can treat many unrelated disorders is a huge red flag that that intervention is almost certainly not science-based and is probably quackery. So it is with acupuncture; yet, that hasn’t stopped the doyens of integrative medicine at the most respected medical schools from being seduced by the mysticism of acupuncture and studying it. I can’t entirely blame them. I must admit, there was a time when even I thought that there might be something to acupuncture. After all, unlike so many other CAM interventions, acupuncture involved doing something physical, inserting actual needles into the body. However, as I critically examined more and more acupuncture studies, I eventually came to agree with David Colquhoun and Steve Novella that acupuncture is nothing more than a “theatrical placebo.”
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Posted in: Acupuncture, Cancer, Clinical Trials, Traditional Chinese Medicine

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Chiropractic- Ignoring the Precautionary Principle Since 1895

My reaction to reading the paper discussed herein, were I a handsome Spaniard.

My reaction to reading the paper discussed herein, were I a handsome Spaniard.

Bleh. I turned from a short trip to the city of angles with a bad man cold that just isn’t going away. Those who do primary care all tell me that whatever is going around lasts 2-3 weeks. Great. I am not sick enough to get out of work but I am not well enough to have any enthusiasm to do anything. I look at the key board and sigh. I just want to binge watch something mindless.

I know Harriet covered “Systematic Review and Meta-analysis of Chiropractic Care and Cervical Artery Dissection: No Evidence for Causation” last week. But it is one thing to read the evaluation of a paper and quite another to evaluate a paper on your own. It is the latter process where you, and by you I mean me, actually learn something. I write mostly for my edification, not yours. Sorry. It is all about me. I will likely read Harriet’s post this weekend.

The issue at hand is whether chiropractic manipulation can cause a stroke. (more…)

Posted in: Chiropractic, Clinical Trials, Critical Thinking

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Statins for everyone? Not so fast.

In rosuvastatin we trust?

In rosuvastatin should we trust?

People love the idea of preventive medicine. Preventing a disease, before it occurs, seems intuitively obvious. But when it comes to taking medicine to prevent a disease before it occurs, people tend to be much less comfortable. Not only are there the concerns about the “medicalization” of healthy people, there are good questions about benefits, risks, and costs. Cardiovascular disease will kill many of us, so there’s been decades of research studying how to prevent that first heart attack or stroke. But even if you’re born with good genes and do everything possible to prevent heart disease (e.g., don’t smoke, exercise regularly, eat a healthy diet, moderate your alcohol, and keep your weight down) you’re still at risk of heart disease. And if you have one or more risk factors for disease, your lifetime risk goes up dramatically. Once you’ve had your first heart attack or stroke, the effectiveness of medical therapy is clear. Drug therapy with medication like the “statins” class of cholesterol-lowering drugs reduces deaths from cardiovascular disease. Given their unambiguous effectiveness, and the high likelihood that many of us will eventually have cardiovascular disease of some sort, the idea of “pre-treating” otherwise-healthy people with drug therapy to possibly prevent that first event has been held out as a potential public health strategy. There’s new evidence that tests this hypothesis, and the results are surprising. (more…)

Posted in: Clinical Trials, Public Health

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NCCIH Strategic Plan 2016-2021, or: Let’s try to do some real science for a change

NCCIH
It’s no secret that we at Science-Based Medicine (SBM) are not particularly fond of the National Center for Complementary and Integrative Health (NCCIH). Formerly known as the National Center for Complementary and Alternative Medicine (NCCAM) and before that the Office of Alternative Medicine, NCCIH has been the foremost government agency funding research into quackery for the last 24 years, and, of course, that’s the reason we at SBM have been harshly critical of NCCIH since SBM’s inception. Basically, NCCIH not only funds studies of dubious “alternative” therapies, but it also promotes quackery by funding “fellowships” at various institutions to teach “integrative medicine,” or, as we like to call it, “integrating” quackery with real medicine.

Indeed, back in 2009, when President Barack Obama first took office, Steve Novella and I both suggested that the time was ripe for NCCIH to be defunded and its functions allowed to revert back to the already existing Institutes and Centers of the National Institutes of Health. We were under no illusions that this would happen, given that NCCIH always had a powerful protector in the man who was arguably more responsible for creating NCCIH and guarding it against all attempts at defunding or, even worse, forcing it to do more rigorous science, woo-loving Senator Tom Harkin (D-IA). Harkin is no longer in the Senate, having retired at the end of 2014, but NCCIH is still with us, and the nature of government makes it very much that, unless someone with power is willing to expend serious political capital to eliminate it, NCCIH will be with us always, no matter how much it tries to change its name to eliminate anything implying pseudoscience.

So those of us who recognize that NCCIH was created to promote the “integration” of “outside of the mainstream” or “unconventional” treatments (the vast majority of which are quackery) into real medicine have to learn to live with NCCIH and, as much as it might gall us, to try make lemonade out of the lemon by prodding it to doing some actual rigorous science on “complementary and alternative medicine” that have at least a modicum of biological plausibility and avoid wasting taxpayer money on fairy dust treatments whose precepts either violate the laws of physics (e.g., reiki, homeopathy, and other “energy” medicine) or depend on nonexistent anatomy or physiology (e.g., reflexology, craniosacral, traditional Chinese medicine tongue diagnosis).

This brings me to something I saw on the NCCIH Director’s Blog late last week, a post by the director Josephine Briggs, Requesting Comments on NCCIH’s Draft Strategic Plan. Patriotic US citizen and advocate of SBM that I am, how could I turn down such a request? Kimball Atwood didn’t shirk from such a request back when Dr. Briggs was asking for comments on the NCCAM 2011-2015 strategic plan, nor did I.

In fact, you, too, can comment as well. The deadline is April 15.
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Posted in: Basic Science, Clinical Trials, Politics and Regulation

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The hijacking of evidence-based medicine

One of our heroes at SBM: John Ioannidis.

One of our heroes at SBM: John Ioannidis.

It’s no secret that I’m a fan of John Ioannidis. So, I daresay, are pretty much all of the editors and regular contributors to this blog. (If you don’t believe me, just type Ioannidis’ name into the blog search box and see how many posts you find.) Over the last couple of decades, Ioannidis has arguably done more to reveal the shortcomings of the medical research enterprise that undergirds our treatments, revealing the weaknesses in the evidence base and how easily clinical trials can mislead, than any other researcher. Indeed, after reading what is Ioannidis’ most famous article, “Why Most Published Research Findings Are False“, back in 2005, I was hooked. I even used it for our surgical oncology journal club at the cancer center where I was faculty back then. This was long before I appreciated the difference between science-based medicine (SBM) and evidence-based medicine (EBM). So it was with much interest that I read an article by him published last week and framed as an open letter to David Sackett, the father of evidence-based medicine, entitled “Evidence-based medicine has been hijacked: a report to David Sackett.” Ioannidis is also quoted in a follow-up interview with Retraction Watch.

Before I get to Ioannidis’ latest, I can’t help but point out that, not surprisingly, quacks and proponents of pseudoscientific and unscientific medicine often latch on to Ioannidis’ work to support their quackery and pseudoscience. They’ve been doing it for years. Certainly, they’re already latching on to this article as vindication of their beliefs. After all, their reasoning—if you can call it that—seems to boil down to: If “conventional” medicine is built on such shaky science, then their pseudoscience isn’t wrong after all, given that the same scientific enterprise upon which conventional medicine is based produces the findings that reject their dubious claims and treatments. Of course, whenever I hear this line of argument, I’m reminded of Ben Goldacre’s famous adage, seen in one form on Twitter here:

The adage can be generalized to all EBM and SBM as well. Just because big pharma misbehaves, EBM has flaws, and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy, acupuncture, or energy medicine works.

Still, when Ioannidis publishes an article with a title provocatively declaring that EBM has been “hijacked,” we at SBM take notice. (more…)

Posted in: Basic Science, Clinical Trials, Medical Academia, Pharmaceuticals, Politics and Regulation

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American Journal of Public Health article touts “potential public health benefits” of homeopathy

Homeopathy: It's just water.

Homeopathy: It’s just water.

An article in the April, 2016 issue of the American Journal of Public Health caught my eye: “Homeopathy Use by US Adults: Results of a National Survey.” I was pleased to see that homeopathy use is actually quite low. The 2012 National Health Survey found that only 2.1% of U.S. adults used homeopathy in the last 12 months, although that was a 15% increase over 2007. Users were mostly young, white, well-educated women, the typical CAM consumer.

Even fewer saw a homeopathic practitioner (only 19% of all users), although those who did perceived a greater benefit from homeopathic remedies. This difference, speculate the authors, could be due to several factors, one of which is

a more individualized and effective homeopathic prescription by the provider.

What? Are the authors suggesting that the series of off-the-wall questions asked by homeopaths leads to a prescription of an “effective” homeopathic remedy?

They certainly seem to be. Who are these authors, anyway?

They are Michelle L. Dossett, MD, PhD, MPH, Roger B. Davis, ScD, Ted J. Kaptchuk, and Gloria Y. Yeh, MD, MPH. All are, or were, with the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center. All are also connected with Harvard and work, in various ways, in “integrative medicine” research. The article was funded, in part, by the National Center for Complementary and Integrative Health, and in part by Harvard. (more…)

Posted in: Clinical Trials, Homeopathy, Medical Academia, Public Health, Vaccines

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Acupuncture for Coronary Artery Disease

Pictured: Really, really bad idea, on all levels.

Pictured: Really, really bad idea, on all levels; literal, metaphorical, pedagogical, tautological, hemodynamic, pathological, basically all the -ics, -cals, and -als.

I have spent the last 35 years mostly in acute care medicine. Spending my day in the hospital gives me the bias that we are fragile creatures who can die unexpectedly and easily. Much of the time we pull patients through, but I have a great respect for acute diseases. Over the years I have seen too many people wake up feeling good and dead by dinner time

There is a reason the phrase is “as serious as a heart attack”. Heart attacks and heart arrhythmias can kill. About 5% of patients admitted to the hospital with a heart attack die. And 250,000 have sudden death each year, never making it to the hospital, succumbing to their ventricular fibrillation precipitated by acute coronary ischemia. Ted Cruz notwithstanding, you need a functioning heart to live.

Scary stuff. So when I read Pubmed articles like “Effects of Acupuncture at the Yintang and the Chengjiang Acupoints on Cardiac Arrhythmias and Neurocardiogenic Syncope in Emergency First Aid“, I wonder what is going on in the minds of some people. (more…)

Posted in: Acupuncture, Clinical Trials

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Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]

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Posted in: Clinical Trials, Ethics, Legal, Pharmaceuticals, Politics and Regulation

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Are the recommended childhood vaccine schedules evidence-based?

The vaccine schedule: Safe and efficacious.

The vaccine schedule: Safe and efficacious.

We write about vaccines a lot here at SBM, and for a very good reason. Of all the medical interventions devised by the brains of humans, arguably vaccines have saved more lives and prevented more disability than any other medical treatment. When it comes to infectious disease, vaccination is the ultimate in preventive medicine, at least for diseases for which vaccines can be developed. We also know that when vaccination rates fall, it opens the door for diseases once controlled to come roaring back. We saw this phenomenon with the measles a year ago in the Disneyland measles outbreak. We’ve seen it around the country, with measles outbreaks occurring in areas where a lot of antivaccine and vaccine-averse parents live. Perhaps the most spectacular example occurred in the UK, where prior to Andrew Wakefield’s fraudulent case series in The Lancet that was used to link the MMR vaccine to autism, measles was under control; it came roaring back as MMR uptake plummeted in the wake of the publicity his research engendered. By 2008, ten years after Wakefield’s case series was published, measles was again endemic in the UK. Measles outbreaks flourished. Although MMR uptake is improving again in the UK, there remains a reservoir of unvaccinated children aged 10-16 who can transmit the virus.

Thanks, Andy.

Fortunately, Wakefield has been relegated to sharing the stage with crop circle chasers, New World Order conspiracy theorists, sovereign citizen cranks, and other antivaccine cranks like Sherry Tenpenny. Unfortunately, the damage that he has done lives on and has metastasized all over the developed world. Given the persistence of the antivaccine movement, which fuels concerns about vaccines in parents who are not themselves antivaccine but are predisposed to the antivaccine message because they distrust government and/or big pharma or have a world view that overvalues “naturalness,” I was quite interested in an article that appeared in The BMJ last week. Basically, it asked the question “Is the timing of recommended childhood vaccines evidence based?
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Posted in: Clinical Trials, Epidemiology, Public Health, Vaccines

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