Articles

FDA efforts to improve compounded drug safety upsets naturopaths

herbs-nd1
Favorite naturopathic treatments comprise pumping patients full of dubious mixtures by injection, including IV drips. Naturopaths also employ topicals (salves, ointments and creams), rectal, and vaginal suppositories, and oral medications, such as bio-identical hormone replacement therapy, all made from “natural” substances.

According to the American Association of Naturopathic Physicians (AANP)

these nutritional, herbal and homeopathic remedies are compounded to meet unique patient needs and are not typically available from the large drug manufacturers that don’t make small batches of such specialized products.

Not to mention the fact that it is highly doubtful these questionable remedies could make it through the FDA drug approval process, which requires proven safety and efficacy.

The FDA’s recent steps to improve drug compounding safety is a welcome curb on these practices. Draft Guidance issued in April addresses both compounding for office use and by prescription. (“Office use” refers to creating a supply of a compounded drug to be used by a health care practitioner as needed, as opposed to compounding a drug per a specific prescription for an individual patient.) In June, the FDA also issued an Interim Policy on substances that can be used in compounding a drug. We’ll discuss how these affect naturopathic practice in a moment. (more…)

Posted in: Guidelines, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation

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New Study Questions fMRI Validity

fmri
One way to describe our overall editorial stance at SBM is that we are criticizing medical science in a constructive way because we would like to see higher standards more generally applied. Science is complex, medical science especially so because it deals with people who are complex and unique. Getting it right is hard and so we need to take a very careful and thoughtful approach. There are countless ways to get it wrong.

One way to get it wrong is to put too much faith in a new technology or scientific approach when there has not been enough time to adequately validate that approach. It’s tempting to think that the new idea or technology is going to revolutionize science or medicine, but history has taught us to be cautious. For instance, antioxidants, it turns out, are not going to cure a long list of diseases.

One recent technology that is very exciting, but insiders recognize is very problematic, is perhaps even more problematic than we thought –functional MRI scans (fMRI). A new study suggests that the statistical software used to analyse the raw data from fMRIs might be significantly flawed, producing a flood of false positive results.

An fMRI primer

MRI scanning uses powerful magnets to image soft tissue in the body. The magnets (1.5-3 Tesla, typically) align the spin of hydrogen atoms in water molecules with the magnetic field. The time it takes for the atoms to align and then relax depends on the characteristics of the tissue. The MRI scan therefore sees subtle differences in tissue (density, water content) and uses this information to construct detailed images. (more…)

Posted in: Neuroscience/Mental Health

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Vegan Betrayal: The Myths vs. the Realities of a Plants-Only Diet

If vegans really followed these guidelines, they could get adequate nutrition; but all to often they don't.

If vegans really followed these guidelines, they could get adequate nutrition; but all too often they don’t.

 

NOTE: The original version of this book review was criticized for not making it clear when I was simply reporting the book’s content and when I was expressing support for one of its arguments. I have revised it to make it more clear. The additions are marked by brackets.

 

Vegetarians come in several flavors. Ovo-vegetarians eat eggs, lacto-vegetarians eat dairy products but not eggs, ovo-lacto-vegetarians eat both eggs and dairy products. Pescatarians eat fish but no other animals. Vegans eat nothing derived from animals. Vegans have claimed that a plants-only diet offers a multitude of health benefits, is better for the environment, and is the only ethical choice. While some of them respect the dietary choices of others, some of them proselytize with religious-like fervor and are working to get their diet adopted by all of humanity. In her new book, Vegan Betrayal: Love, Lies, And Hunger In A Plants-Only World, Mara Kahn questions those beliefs, pointing out that no human population has ever endured on a plants-only diet; that while some studies have shown short-term health benefits, long-term follow-up is missing; that long-term vegans frequently experience “failure to thrive,” go off their diet, and feel better when they return to eating meat; and that veganism might actually harm the environment and might not even save animal lives overall.

The book is really three books interleaved into one:

  • The story of her own experiences as a vegan.
  • An evidence-supported analysis of veganism and vegetarianism
  • Some rather woo-woo ideas about finding a unique diet for each individual

I can highly recommend the first two, but I deplore the third. (more…)

Posted in: Book & movie reviews, Nutrition

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Forget stem cell tourism: Stem cell clinics in the US are plentiful

Snake Oil Salesman & Wagon
I had planned on writing about something else this week, but late last week another story caught my eye, because it served as a perfect follow-up to what I wrote about last week. To recap, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to function more normally in life. Mr. Gass was both driven enough, credulous enough, and wealthy enough to spend $300,000 pursuing stem cell tourism in China, Mexico, and Argentina over the course of four years. The result is that he now has a tumor growing in his spinal column, as reported in The New England Journal of Medicine (NEJM) and The New York Times (NYT). Genetic analysis has demonstrated that the cells in this tumor mass did not come from Jim Gass, and the mass has left him paralyzed from the neck down, except for his right arm, incontinent, and with severe chronic back pain. Worse, although radiation temporarily stopped the tumor from growing, apparently it’s growing again, and no one seems to know how to stop it. Given that the traits that make stem cells so desirable as a regenerative treatment, their plasticity and immortality (ability to divide indefinitely), are shared with cancer, scientists doing legitimate stem cell research have always tried to take precautions to stop just this sort of thing from happening in clinical trials. Clearly, “stem cell tourist” clinics, which intentionally operate in countries where the regulatory environment is—shall we say?—less than rigorous are nowhere near as cautious, as they charge tens of thousands of dollars a pop for stem cell treatments that might or might not actually have real stem cells in them.

At the time I wrote that article, I emphasized primarily clinics outside of the US, where shady operators locate in order to be able to operate largely unhindered by local governments. You’d think that such a thing couldn’t possibly be going on in the US. You’d be wrong. Last week, Paul Knoepfler, a stem cell scientist who has previously contributed to Science-Based Medicine, teamed up with Leigh Turner to publish a paper in Cell Stem Cell estimating the number of stem cell clinics in the US. The number they came up with astonished me. (more…)

Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Horses, Zebras, and the Availability Heuristic

It was a chevrotain.

It was a chevrotain. (Josh More, Flickr)

During a particularly difficult shift early in my career, I spent the better part of two hours at the bedside with a patient’s family discussing the unexpected discovery of a large tumor in their child’s brain. The implications of the finding were grave, and the family was understandably devastated. I was just a few years out of residency and this was the first time I had made such a life altering diagnosis by myself, and it was by far the hardest news I had ever had to break to a family. Needless to say it was an experience that I will never forget, and one that has influenced my approach to medicine ever since.

The diagnosis was a surprise to everyone. There were of course red flags that appropriately led to the ordering of an MRI, but I really didn’t expect it to find anything. It wasn’t based on the fear of a lawsuit or the discomfort with uncertainty, influences that dictate the practice of medicine far too often, with the latter being considerably more of a problem (in my opinion). There was enough to support embarking on an encephalic expedition, but nothing so blatant as to really raise my suspicions.  My guard was down and my emotional response to the situation was intense. Later, after care of the patient had been transferred to the pediatric oncology service, my introspective nature took over.

The sound of approaching hoofbeats

In medical school, there is an old adage often passed down to learners by seasoned physicians that serves to rein in an overly broad differential diagnosis, particularly when it includes increasingly unlikely etiologies. When one hears the sound of approaching hoofbeats, the inexperienced students are cautioned, one should expect to see horses rather than zebras. The world of medicine rarely mimics an episode of House, M.D. (more…)

Posted in: Science and Medicine

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A systematic review about nothing

Water
There is dubious content in PubMed that you won’t find unless you look for it, or stumble across it inadvertently. It’s the entire field of alternative medicine which is abstracted and complied along with the actual medical literature. In this world, the impossible is accepted as fact, and journal articles focus on the medical equivalent of counting angels on pinheads. I’ve been trying to avoid blogging about alternative medicine practices like homeopathy lately because the practice itself is a scientific dead end. There is no emerging evidence or interesting research to describe, because there is no science to build on. But research on homeopathy is interesting if one wants to understand how placebo effects can appear to be real. Importantly, research and clinical trials of homeopathy allow us to see the underlying (baseline) challenges, flaws, and biases in evaluating real medicine more clearly. Today I want to review a newly-published systematic review of, adverse effects attributed to homeopathy. The casual reader might not see the multiple problems with this type of research. But once you understand the basis of homeopathy, the conclusion that one can draw is quite different from that of the author’s. And if inert sugar pills can appear to have medicinal effects, and even adverse effects, then we can better adjust for these biases when we’re studying actual medicine. (more…)

Posted in: Clinical Trials, Homeopathy

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Australia’s New Antiscience Party

HAPIn a perfect world, high quality science would inform politics and policy. Science cannot determine policy by itself because there are also value judgments and trade-offs that need to be negotiated. At the least, however, policy should be consistent with the best available science.

We, of course, don’t live in a perfect world. Too often politics and ideology seem to inform, or corrupt, science. It is so much easier to just cherry pick the science that seems to confirm what you already believe, than to go through the process of changing your beliefs to accommodate the evidence. The stronger the ideology, the greater the motivated reasoning used to defend it, without apparent practical limit. For core ideologies that are part of someone’s identity, there does not appear to be any amount of evidence that will change their beliefs.

Anti-scientific motivated reasoning is often codified in specific organizations, institutions, or professions. Political parties are essentially organized ideologies, and when that ideology is predominantly pseudoscientific, you have organized pseudoscience. (more…)

Posted in: Politics and Regulation

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The THRIVE Experience: Masterful Marketing, Short on Substance

One of the few things that aren't in THRIVE products

One of the few things that aren’t in THRIVE products

My daughter told me about the latest health fad among her group of acquaintances. She knows people who are spending $300 a month on the THRIVE program and claiming miraculous results. With a skeptic for a mother, my daughter knew enough to question the claims and do her own research; she was not impressed. She concluded that THRIVE was essentially selling caffeine and vitamins at exorbitant prices.

Claims on the website

THRIVE is offered by Le-Vel Brands, LLC. A slick video on the website asks:

Are you ready to hear about the hottest weight loss, nutrition and fitness plan sweeping North America? It’s called the THRIVE 8-week experience. The only premium lifestyle transformation plan. People from all walks of life are accomplishing their physical goals with THRIVE, and many are also accomplishing their financial goals by choosing to promote the experience.

  • Weight management
  • Joint support
  • Pain management
  • Antioxidant support
  • Cognitive performance
  • Lean muscle support
  • Anti-aging
  • Digestive and immune support
  • Calms general discomfort

“You’re going to live, look, and feel Ultra Premium like never before.”

Testimonials: yes. Hype: yes. Evidence: no. (more…)

Posted in: Herbs & Supplements

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What’s the harm? Stem cell tourism edition

What's the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There's the harm.

What’s the harm? Stroke victim Jim Gass went from requiring a cane and leg brace to walk to being confined to a wheelchair, thanks to dubious stem cell treatments. There’s the harm.

It’s been over two weeks now since hockey legend Gordie Howe died at the age of 88. Detroit, as I’ve pointed out elsewhere, is a serious hockey town, as hockey-crazy as any town in Canada (just look at the fancy new hockey arena named after crappy pizza being built downtown only a mile from where I work), and it worshiped Gordie Howe for as long as I can remember growing up here.

The reason I mentioned this is because in late 2014, Howe suffered a series of debilitating strokes that brought him close to death. He survived, but with major neurologic deficits. As a result of Gordie Howe’s fame, representatives of a company known as Stemedica who were also fans of Gordie Howe and whose company is developing stem cell treatments for a variety of illnesses, approached the family and persuaded them to take Gordie Howe to the Novastem Clinic in Tijuana, a clinic that to me appeared to exist mainly as a means for patients not eligible for Stemedica’s clinical trials in the US to receive Stemedica’s stem cells outside of a clinical trial, cash on the barrelhead, no questions asked. In a rather ethically dubious move that could only be viewed as paying for publicity (which it got in abundance), Stemedica administered its stem cells to Gordie Howe for free. If you’re not Gordie Howe, however, it’ll cost you about $32,000.

As is the case for most anecdotes like this, Gordie Howe did improve. That is not surprising, because, as Steve Novella, who is a neurologist and thus takes care of stroke patients as part of his practice, told me at the time, the natural history of stroke is neurologic recovery that eventually plateaus several months after the stroke. This occurs as the inflammation from the initial stroke abates and as much regeneration as the body can muster occurs. Also, as I noted before, Howe had a hemorrhagic stroke, which is more dangerous and likely to kill early but, if the victim survives, he is more likely to experience better functional recovery than in the case of the much more common ischemic stroke, in which a blood clot clogs a blood vessel, resulting in the death of brain tissue supplied by that vessel. In any case, as I described in a three part series of posts (part one, part two, part three), it’s impossible to know whether the stem cell infusion that Howe underwent had anything whatsoever with his partial recovery that allowed him to make a few public appearances in 2015 and 2016.

Unfortunately, the offer by Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies to treat Gordie Howe at Novastem worked brilliantly. Gordie Howe quickly became the poster child for dubious stem cell therapies. Local and national news aired credulous, feel-good human interest stories about his seemingly miraculous recovery, while Keith Olbermann practically served as a pitch man for Stemedica and didn’t take kindly at all to any criticism of his—shall we say?—enthusiastic coverage. The predominant angle taken in stories about Gordie Howe was he had undergone Stemedica’s stem cell therapy and, as result, enjoyed a “miraculous recovery” from his stroke. The vast majority of news coverage also tended to present the magic of stem cell therapies credulously, as all benefit and no risk, as a qualitative analysis published last year clearly showed, finding that the “efficacy of stem cell treatments is often assumed in news coverage and readers’ comments” and that media coverage “that presents uncritical perspectives on unproven stem cell therapies may create patient expectations, may have an affect [sic] on policy discussions, and help to feed the marketing of unproven therapies.”

No kidding.

Why, you might ask, am I reminding you of Gordie Howe’s use of stem cells to treat his strokes? Simple, it became part of a marketing blitz, credulously swallowed whole by Keith Olbermann and many reporters, for unproven stem cell therapies, which have been portrayed as very promising (which is likely true, although that promise hasn’t yet been proven or realized) and harmless, which is definitely not true, as evidenced by the story of Jim Gass, as published last week in The New England Journal of Medicine, The New York Times, The Boston Globe, and a variety of other media. Before I discuss Mr. Gass in more detail, however, let’s recap a bit about stem cells. (more…)

Posted in: Clinical Trials, Ethics, Health Fraud, Science and the Media

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Book Review Lagniappe

bookworm
Lagniappe, a word often heard in New Orleans, refers to a bonus or extra gift, like the thirteenth donut in a baker’s dozen. You may have noticed that I write a lot of book reviews. I read far more books than I review, and I have always loved to read about the experiences of doctors and the interesting patients and intriguing illnesses they have encountered. I thought I would write an extra post this week to share some titles that SBM readers might also enjoy.

I value these books for several reasons. They are entertaining. They prove that doctors are not all evil Big Pharma shills just in it for the money. They let readers vicariously experience what it is like to be a doctor in a particular specialty or setting. They highlight the joys of helping patients, as well as the many frustrations doctors struggle with. They put a human face on the practice of medicine. (more…)

Posted in: Book & movie reviews

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