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Another way ibuprofen can kill us?

Does ibuprofen really raise your risk of heart failure by 83%? No.

Does ibuprofen really raise your risk of heart failure by 83%? No.

Do you ever take ibuprofen? Naproxen? Cold medication with an anti-inflammatory ingredient? The non-steroidal anti-inflammatory drugs (NSAIDs) are among our most well-loved medications. We start giving them in infancy, for fever, and continue use through to adulthood for everyday aches and pains. But it’s our later stages of life when we really ramp up the use, and daily consumption becomes common for conditions like arthritis. While they may be easily accessible and included as ingredients in thousands of consumer products, NSAIDs have a long list of potentially serious side effects. Not only can they cause stomach ulcers and bleeding by damaging the lining of the gastrointestinal tract, they can also increase the risk of fatal cardiovascular disease. Now there’s new research that looks at the relationship between NSAIDs and heart failure, a condition where the heart cannot pump adequately and appropriately. The study, “Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study” resulted in some fairly dramatic, alarming headlines:
daily mirror headline NSAIDS ibuprofen heart failure

Headlines like this suggest that NSAIDs are killing us indiscriminately, which may make you wonder how so many of us manage to have lived this long. And while The Daily Mirror got the facts wrong, they quoted from a well-conducted study. There is a real risk of heart failure from NSAIDs. But context is everything. (more…)

Posted in: Science and Medicine

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FDA Warns About Homeopathic Teething Products

homeopathic-teething-croppedThe FDA recently put out a consumer warning about homeopathic teething gels and pills. The warning states:

The FDA recommends that consumers stop using these products and dispose of any in their possession.

The warning is not because all homeopathic products are inherently useless. As we have discussed here often, the basic principles of homeopathy are pure pseudoscience. The practice of diluting substances so that almost no or no active ingredient remains means that most homeopathic products are just sugar pills. Further, clinical studies show that homeopathic products don’t work. There isn’t a single homeopathic product that has been shown to be effective for a single condition with rigorous clinical trials.

The FDA acknowledges this, writing in their warning:

Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.

(more…)

Posted in: Homeopathy

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Plavinol and Other Natural Remedies for Diabetes: “Condimentary Medicine”?

Is this an effective medicine or a condiment?

Is this an effective medicine or a condiment?

We don’t yet have a cure for diabetes, but we have insulin; it controls the disease and allows Type 1 diabetics to lead a relatively normal life instead of suffering and quickly dying as they all did in the pre-insulin era. We know to counsel Type 2 diabetics about weight loss, diet, and exercise; and when those measures are not enough, we have prescription medications that work very well to control symptoms and help prevent complications.

For some people, that’s not good enough. They want to find “natural” remedies to supplement or replace conventional treatments. In a recent article on SBM, Scott Gavura quoted a pharmacy customer who said “I don’t want to take any drugs. Do you have something natural I can use to cut my blood sugar?” Scott went on to cover the questionable evidence for cinnamon in that article. Many other “natural” remedies have been proposed. Here’s an alphabetical list: acetyl L-carnitine, aloe, alpha-lipoic acid, banaba leaf (not banana!), basil, berberine, bilberry, biotin, bitter melon, cinnamon, chromium, coQ10, crepe myrtle, fenugreek, fish oil, fructo-oligosaccharides, green tea, ginseng, glucomannan, gymnema, hibiscus, Indian kino tree extract, magnesium, mistletoe, olive leaf, onion, psyllium, purslane, resveratrol, starch blockers, thiamine, vanadium, and vitamins. I compiled that list from just three websites; I’m sure there are many more natural remedies that I missed. These natural remedies have been recommended on the basis of rather shaky preliminary evidence that they lower blood sugar, usually by only a small amount. Even the CAM-friendly National Center for Complementary and Integrative Health (NCCIH) concluded:

There is not enough scientific evidence to suggest that any dietary supplements can help prevent or manage type 2 diabetes.

They also warn that “Some dietary supplements may have side effects, including interacting with your diabetes treatment or increasing your risk of kidney problems.” (more…)

Posted in: Herbs & Supplements

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When science- and evidence-based guidelines conflict with patient wishes: What’s a doc to do?

Evidence-based medicine triad

There’s a misconception that I frequently hear about evidence-based medicine (EBM), which can equally apply to science-based medicine (SBM). Actually, there are several, but they are related. These misconceptions include the idea that EBM/SBM guidelines are a straightjacket, that they are “cookbook medicine,” and that EBM/SBM should be the be-all and end-all of how to practice clinical medicine. New readers might not be familiar with the difference between EBM and SBM, and here is not the place to explain the difference in detail because this post isn’t primarily about that difference. However, for interested readers, a fuller explanation can be found here, here, here, and here. The CliffsNote version is that EBM fetishizes the randomized clinical trial above all other forms of medical investigation, a system that makes sense if the treatments being tested in RCTs have a reasonably high prior probability of translating to human therapies based on basic science mechanisms, experimental evidence in cell culture, and animal experiments. Using Bayesian considerations, when the prior probability is very low (as is the case for, for example, homeopathy), there will be a lot of false positive trials. Such is how EBM was blindsided by the pseudoscience of “complementary and alternative medicine” (CAM) or, as it is called now, “integrative medicine.”

However, for purposes of this post, SBM and EBM can be considered more or less equivalent, because we are not going to be discussing CAM, but rather widely accepted treatment guidelines based on science, both basic and clinical trial science. I merely mention this difference for completeness and for new readers who might not be familiar with the topics routinely discussed here. For purposes of this post, I’m talking evidence-based guidelines from major medical societies. More specifically, I want to address the disconnect between what patients often want and what our current guidelines state. It’s not just patients either, but doctors; however, for purposes of this post I’m going to focus more on patients. It’s a topic I’ve addressed before, in particular when it comes to breast cancer, where I’ve discussed changes in the mammography screening guidelines and Choosing Wisely guidelines for breast cancer. There are many other examples that I haven’t discussed. (more…)

Posted in: Cancer, Diagnostic tests & procedures

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Infectious Diseases and Cancer

coley

Dr. William Coley. Not a brain surgeon.

With apologies to my colleagues, but infectious diseases really is the most interesting specialty in medicine. There are innumerable interesting associations and interactions of infectious diseases in medicine, history, art, science, and, well, life, the universe and everything. ID is so 42.

A recent email led me to wander the numerous interactions between infections and cancer.

There are the cancers that are caused by infection. HPV and cervical and throat cancer. EBV and lymphoma. HHV8 and Kaposi’s Sarcoma. I certainly hope I am not reincarnated as a Tasmanian Devil. (more…)

Posted in: Basic Science, Cancer, Clinical Trials, Epidemiology, Science and Medicine, Vaccines

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Personal Care Products Safety Act: Facelift for FDA Regulation or Lipstick on a Pig?

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

Ad from the 1930s, when cosmetics regulation was last addressed by Congress.

The U.S. cosmetics industry, the largest in the world, is expected to reach $62 billion in revenues in 2016. Yet, despite the fact that its products are regularly applied to, and absorbed by, the body’s largest organ (the skin) and even ingested in small amounts, the cosmetics industry is largely self-regulating.

There are over 57,000 different chemicals used in cosmetics. According to one research report, on average, women use 12 personal care products every day, exposing themselves to 168 chemical ingredients. Men use about half that, but still expose themselves to 85 unique chemicals a day. Many of these may be perfectly safe, we just don’t know which ones because most have not been tested for safety.

Increasing concerns about everything from contact dermatitis to carcinogens led Senators Dianne Feinstein (D-California) and Susan Collins (R-Maine) to introduce the Personal Care Products Safety Act, giving the FDA greater regulatory oversight of the cosmetics industry. The Senate Committee on Health, Education, Labor & Pensions held a hearing, “Exploring Current Practices in Cosmetic Development & Safety” last Thursday. A similar bill has been introduced in the House of Representatives. At least one other House bill was introduced in 2013 attempting to strengthen FDA regulatory authority over cosmetics, but it went nowhere. (more…)

Posted in: Cancer, Legal, Politics and Regulation

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Ultraviolet Blood Treatment Revisited

A man undergoing blood irradiation therapy.

A man undergoing blood irradiation therapy.

If there is one thing this election cycle has demonstrated it’s that, when ideology or emotions are involved, people can be entirely immune to facts. The narrative takes control, reinforced by motivated reasoning and confirmation bias.

Even worse, people tend to think they are actually informed, and are confident in their opinions, even when they are grossly misinformed. Regular contributors here frequently receive e-mails from people who truly believe they have it all figured out – modern medicine is a con and we are all shills, while alternative gurus speak the Truth. The confident reality distortion is amazing to behold.

A total lack of ethics and regulation

Let’s take one stunning example from the world of alternative medicine – ultraviolet blood treatment. Britt Hermes, who has contributed to SBM before, is an ex-naturopath who wrote recently about a medical device called the UVLrx. This is a device that is inserted into a vein like a catheter, and then emits UV light directly to the blood.

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Posted in: Health Fraud, Medical devices, Naturopathy

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Studying Chiropractic with Imaging: Another Dead Salmon?

The Activator: a spring-loaded thumper. Is this "chiropractic"? Does it really balance the alignment of the lumbar spine and sacrum?

The Activator: a spring-loaded thumper. Is this “chiropractic”? Does it really “balance the alignment of the lumbar spine and sacrum”?

Researchers in Japan have done a study evaluating the effects of chiropractic treatment using MRI and PET scans. It was published in the 2009 report of the Cyclotron and Radioisotope Center (CYRIC) of Tokohu University.

Their rationale for doing the study

Ray Hyman‘s categorical imperative is “Do not try to explain something until you are sure there is something to be explained.” These researchers believe there is something to be explained. They think chiropractic has proven clinical benefits and they are trying to find the underlying physiological mechanisms. They think they have found something with their advanced imaging procedures, but the dead salmon study and Satel and Lilienfeld’s book Brainwashed have taught us that neuroimaging studies can be misleading and must be interpreted with great caution.
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Posted in: Chiropractic

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The stem cell hard sell, Stemedica edition

The stem cell hard sell returns.

The stem cell hard sell returns.

I first became more interested in dubious stem cell clinics nearly two years ago, when I learned that hockey legend Gordie Howe was undergoing stem cell therapy in Mexico to treat his stroke. Prominent in stories about Howe were two companies: Stemedica Cell Technologies, a San Diego company marketing stem cell treatments for all manner of ailments, and Novastem a partner company in Mexico that uses Stemedica products. Also prominent in the stories was Clínica Santa Clarita, the Tijuana-based clinic where Howe received his stem cell infusion. As far as I was able to glean, it’s a clinic to which Novastem supplies Stemedica stem cells. Basically, what happened is that Stemedica CEO Dr. Maynard Howe (no relation to Gordie Howe’s family) and VP Dave McGuigan contacted the Howe family late 2014, after having seen news stories about how poorly Gordie Howe was doing, to offer Howe its stem cell therapy.

Unfortunately, Gordie Howe was not eligible for Stemedica’s US-based clinical trial of its stem cell product for stroke because it had not yet been over six months since his last neurologic event and he was not yet neurologically stable. So Maynard Howe and McGuigan steered the Howe family to Novastem, one of Stemedica’s international partners. As a result, under the auspices of a highly dubious “clinical trial” conducted by physicians utterly unqualified to run a decent clinical trial under Mexican regulations that basically allowed “approved” clinics to do anything they want with stem cells, (whose details I discussed at the time), Gordie Howe received Stemedica stem cell infusions at Clínica Santa Clarita.

Because of Gordie Howe’s celebrity and the admiration Howe and McGuigan had for him, Novastem even waived the normal $30,000 per infusion charged to typical patients. From my viewpoint, they used Gordie Howe as a marketing tool, with the waived $30,000 an investment in publicity. Unfortunately Gordie Howe’s son Murray Howe, who happens to be a radiologist, was all too happy to go along, expressing an extreme sense of obliviousness and entitlement in response to questions about whether Clinica Santa Maria treated his father Gordie for free, responding, “You betcha. They were thrilled and honored to treat a legend. Would you charge Gordie Howe for treating him? None of his doctors ever do. I certainly am not going to criticize them for being generous.” Let’s just put it this way. I doubt that Gordie Howe’s other physicians refrained from charging Medicare and whatever insurance Howe had at the time for their services or collecting their copays.
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Posted in: Clinical Trials, Politics and Regulation, Science and the Media

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American Academy of Pediatrics Calls for End to Pediatric Codeine Use…Again

So, pretty please...with sugar on top. Stop prescribing codeine to kids.

So, pretty please…with sugar on top. Stop prescribing codeine for children.

The safe and effective management of subjective symptoms in the pediatric population, in particular pain, has always been difficult. Young patients, even premature infants at the limit of viability, experience pain, a fact that sadly was not widely accepted until the late last century. But even with full recognition of pain as a potential concern in all pediatric patients, undertreatment of pain remains a system wide issue.

Pediatric pain management is especially challenging for a variety of reasons. Overall there are fewer pediatric friendly pharmaceutical options to choose from and limited data on available pain medications for children, leaving pediatric providers fitting square pegs in the round hole of adult medicine. Further complicating the situation is the fact that kids can have significantly different absorption and metabolism of drugs compared to adults. Finally, young children are more likely to be undertreated because of the reluctance to prescribe, or to consent to the use of, opioid medications by providers and caregivers respectively.

As if things weren’t difficult enough, the AAP Section on Anesthesiology and Pain Medicine has published a clinical report in the September Pediatrics that aims to remind providers that it is “time to say no” to one of the our most popular pain medications: codeine. Sadly, the authors are not raising new concerns. Instead, they are once again pointing out serious problems with this drug, problems we have known about for over a decade that have resulted in deaths and inadequately treated pain.
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Posted in: Science and Medicine

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