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Integrative medicine, naturopathy, and David Katz’s “more fluid concept of evidence”

The Integrative Medicine Wheel

The Integrative Medicine Wheel

Dr. David Katz is undoubtedly a heavy hitter in the brave new world of “integrative medicine,” a specialty that seeks to “integrate” pseudoscience with science, nonsense, with sense, and quackery with real medicine. In fairness, that’s not the way physicians like Dr. Katz see it. Rather, they see it as “integrating” the “best of both worlds” to the benefit of patients. However, as we’ve documented extensively here, on our personal blogs, and even in the biomedical literature (plug, plug), what “integrative” medicine means in practice is indeed what I characterized, the infiltration of woo into medicine. This infiltration seems to have started mainly in academia—hence the term “quackademic medicine” and “quackademia”—with the steady infiltration of nonsense into medical schools and academic medical centers, but has since metastasized to the world of community hospitals. This “integration” (or, as I like to refer to it, “infiltration”) has become so pronounced that a few years ago The Atlantic published an article entitled “The Triumph of New Age Medicine“, and just last December the Journal of the National Cancer Institute (JNCI) published a monograph full of articles touting “integrative oncology,” including guidelines recommended by the Society of Integrative Oncology (SIO) for the “integrative” treatment of breast cancer symptoms.

I mention Dr. Katz for two reasons. First, he’s taken another broadside at us at Science-Based Medicine in blog entry at The Huffington Postwhere else?—entitled “Holism, Holes and Poles” that I’ve been meaning to address for a while. But before I address Dr. Katz’s most recent complaint against science-based medicine (SBM), it’s necessary to step back and look at some history.
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Posted in: Clinical Trials, Homeopathy, Medical Academia, Naturopathy

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FDA and Homeopathy: Part Two.

A

Edward De Vere.  Sort-of.

Friends, FDA, countrymen, lend me your ears;

I come to bury Homeopathy, not to praise it.

The evil that homeopaths do lives after them;

The good is oft interred with their bones;

So let it be with Homeopathy. The noble Ullman

Hath told you homeopathy was effective:

If it were so, it was a grievous fault,

And grievously hath Homeopathy answer’d it.

Here, under leave of Ullman and the rest–

For Ullman is an honourable man;

So are they all, all honourable men–

Come I to speak in Homeopathy’s funeral.

It was my nostrum, faithless and worthless to me:

But Ullman says it was effective;

And Ullman is an honourable man.

He hath brought many provings home to HPUS

Whose prescriptions did the general coffers fill:

Did this in Homeopathy seem effective?

When that the ill have died, Homeopathy hath wept:

Efficacy should be made of sterner stuff:

Yet Ullman says it was effective;

And Ullman is an honourable man.

You all did see that on the Cochrane

I thrice presented Homeopathy a meta-analysis,

Which he did thrice refuse: was this efficacy?

Yet Ullman says it was effective;

And, sure, he is an honourable man.

I speak not to disprove what Ullman spoke,

But here I am to speak what I do know.

Edward De Vere, 17th Earl of Oxford. Sort of.

We only have a vague idea as to what other bloggers are going to write about. Yesterday Jann wrote on the same topic (and Scott the week before), which I will read tomorrow after my post goes up. Why would I want my post to be informed by another’s well-reasoned and thoughtful essay? I have a reputation after all. So here is my response to the FDA. (more…)

Posted in: Homeopathy, Legal

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How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
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Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

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Update on the Tobinick Lawsuit

Gavel-court-legal-law-lawsuit

Last year Edward Tobinick sued the Society for Science-Based Medicine, SGU Productions (the producers of the Skeptics’ Guide to the Universe podcast), Yale University, and me personally for libel and (of all things) false advertising. I am frequently asked how the suit is going so here is an update.

Background

The lawsuit involved an article I wrote on Science-Based Medicine on May 8, 2013. Dr. Tobinick’s practice involves giving perispinal etanercept to treat sciatica, Alzheimer’s disease, traumatic brain injury (TBI), and chronic deficits following stroke. He claims that he can reverse the symptoms of these various conditions within minutes. He uses highly emotional videos and anecdotal evidence to promote his treatments.

Further, he has medical use patents on these and other treatments and charges other physicians a substantial fee for training and a royalty simply for treating patients with his methods. Medical use patents are considered by the AMA and other medical organizations to be unethical and are banned in 80 countries (but not the US).

My original article was highly critical of Tobinick’s practice. I emphasized the fact that he is making dramatic clinical claims, which he himself characterizes as revolutionary, without ever having conducted a single double-blind placebo controlled trial. In my opinion none of these uses of etanercept are supported by adequate clinical evidence. In fact, there are no published double-blind placebo-controlled trials of etanercept for post-stroke symptoms or TBI. There are some studies for sciatica, but a 2013 systematic review concluded:

There was insufficient evidence to recommend these agents when treating sciatica, but sufficient evidence to suggest that larger RCTs are needed.

There is a single pilot study of etanercept for Alzheimer’s – a phase II trial with 41 subjects total. That’s it – this is hardly sufficient evidence on which to revolutionize the treatment of multiple complex neurological disorders. In fact, during the hearing, his own expert testified that we are “not there yet.”

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Posted in: Legal

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Psychology and Psychotherapy: How Much Is Evidence-Based?

psychology gone wrong
Despite all those Polish jokes, Poland has its share of good scientists and critical thinkers. A superb new book illustrates that fact in spades:

Psychology Gone Wrong: The Dark Side of Science and Therapy, by Tomasz Witkowski and Maciej Zatonski, Witkowski is a psychologist, science writer, and founder of the Polish Skeptics Club; Zatonski is a surgeon and researcher known for debunking unscientific therapies and claims in clinical medicine. Together, they turn a spotlight on research and treatment in the field of psychology. They uncover distressing flaws, show that many commonly accepted psychological principles are based on myths, argue that psychotherapy is a business and a kind of prostitution rather than an effective evidence-based medical treatment, and question whether psychotherapy should even exist, since in most cases it offers no advantage over talking to a friend about one’s problems, and in some cases can cause harm. (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health, Science and Medicine

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Angelina Jolie, surgical strategies for cancer prevention, and genetics denialism (revisited)

Angelina Jolie

Angelina Jolie

Sometimes, weird things happen when I’m at meetings. For example, I just got home from the Society of Surgical Oncology (SSO) meeting in Houston over the weekend. Now, one thing I like about this meeting is that, unlike so many other meetings these days—cough, cough, ASCO, I’m looking at you—at the SSO there wasn’t a single talk I could find about “complementary and alternative medicine” (CAM) or, as its proponents like to call it now, “integrative medicine.” It’s also a great chance to get caught up on new science and clinical guidelines in cancer surgery, as well as to see people I tend only to see at these meetings.

However, I must admit that by the last day I tend to be “meeting-ed” out and sometimes my attention wanders. Unfortunately, there are ample ways to indulge that attention deficit. Actually, it’s my iPhone. And it’s Twitter. So it was an odd coincidence that right after a talk by Dr. Deanna Attai about whether surgical oncologists can or should offer genetic counseling services to their patients, when I somehow let myself get into an exchange with Sayer Ji, the “natural health expert” responsible for GreenMedInfo, over BRCA1 mutations and the risk of breast and ovarian cancer, in other words, exactly the sort of thing that Dr. Attai had just discussed. For example:

After a bit of back-and-forth, I got fed up:

This minor Twitter exchange came about because of Angelina Jolie’s announcement in a New York Times op-ed last week entitled “Diary of a Surgery” that she had had her ovaries removed to prevent ovarian cancer due to her being a carrier of a high-risk mutation in BRCA1. As you might recall, I wrote about Jolie’s case two years ago, when she first announced in a NYT op-ed entitled “My Medical Choice” that she had undergone a bilateral mastectomy with reconstruction to decrease her BRCA1-related risk of breast cancer. Although I had discussed the story before, I thought it worth doing again here in a bit more detail. (more…)

Posted in: Basic Science, Cancer, Surgical Procedures

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NECSS and SfSBM: A weekend of science and skepticism

Screen Shot 2015-01-09 at 1.35.26 PM

A day of Science-Based Medicine, a weekend of science and skepticism

NECSS, the North-East Conference on Science and Skepticism, is upon us. Included in the program will be a day of Science-Based Medicine.

Full Conference schedule here with Bill Nye as the Keynote speaker.

SfSBM speakers will be Harriet Hall, Jann Bellamy, David Gorski, Steve Novella and Mark Crislip.

SfSBM speakers will also participate in panels on the 11th and 12th.

NECSS will be held April 9th–12th, 2015, in New York City at the Fashion Institute of Technology.

Description: NECSS welcomes over 400 attendees to New York City for a celebration of science and critical thinking. Through individual presentations, panel discussions, and performances, attendees are informed and inspired by leading scientists, educators, activists, and performers – each bringing their own perspective and passion to the goal of fostering a more rational world.

The SfSBM program will be Friday, April 10 and you can attend one or more of the days. $95 for one day or $195 for the entire conference.  The target audience of the SfSBM presentations will be the general population.

SfSBM Program

09:00 – 10:00 60 minutes Registration/Will Call
10:00 – 10:10 10 minutes OPENING: Steve Novella and David Gorski
10:10 – 10:45 35 minutes: Steve Novella. SBM – Going Beyond Evidence-Based Medicine.
10:45 – 11:20 35 minutes: Harriet Hall. Chiropractic: Not All It’s Cracked Up To Be.
11:20 – 11:55 35 minutes: David Gorski. Integrative Medicine: Integrating Cow Pie with Apple Pie
11:55 – 12:30 35 minutes: Mark Crislip. How Acupuncture ‘Works’
12:30 – 02:00 90 minutes LUNCH
02:00 – 02:35 35 minutes Speaker 4: Jann Bellamy. Political Pseudoscience
02:35 – 03:35 60 minutes Panel  Placebo Effect and More
03:35 – 03:50 15 minutes BREAK
03:50 – 04:35 45 minutes Q&A from Twitter & Audience
04:35 – 05:20 45 minutes SBM Jeopardy
05:20 – 05:30 10 minutes CLOSING
05:30 – 06:00 30 minutes SBM Business Meeting

For more information and to register, go to NECSS or this registration page.

The Society for Science-Based Medicine is a co-sponsor of NECSS and paid SfSBM members can get a 15% discount using the code SFSBM2015.

Also at NECSS

 SGU Skeptical Extravaganza with guest star Bill Nye

 April 10, 2015 @ 7:30PM

Haft Auditorium, 227 W. 27th St., NY, NY 10001

Cost: $25 general public / $15 NECSS attendees

Website: www.necss.org/extravaganza

Special guest Bill Nye joins multi-talented musician George Hrab and the award-winning Skeptics’ Guide to the Universe podcast for a two-hour stage show celebrating science, skepticism, and everything geeky (including the ever-popular quiz show). Best of all, tickets are open to the general public; conference registration is not required to attend!

Posted in: Announcements

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Separating Fact from Fiction in the Not-So-Normal Newborn Nursery: Chiropractic and Craniosynostosis

cranialsutures

Pediatricians, particularly those who spend a significant amount of time caring for newborns, see a lot of babies with unusually-shaped heads. Although to be fair, the fact that the overwhelming majority of vaginally-delivered babies, and quite a few born via Caesarean section, will have a transient and abnormal shape to their heads makes it, well, not unusual. In fact, I rarely make it out of the room without some discussion and reassurance regarding the lumps and bumps of a new arrival’s head.

The potentially lumpy and misshapen head of the newborn occurs for a variety of reasons, some common and some extremely rare. It often is related to the development of the bones of the skull but can also involve the surrounding tissues of the scalp. A vaginal delivery, and some difficult Caesarean births, subject a baby’s head to a lot of pressure. This pressure frequently results in swelling of the scalp that can be quite impressive, but tends to resolve in a day or two.

This same pressure can also cause bleeding, perhaps because of an insufficient amount of vitamin K available to optimally activate clotting, that collects under the top layer of one or more of the bones of the skull. These cephalohematomas can also be impressive and may take weeks to completely resolve. Rarely the trapped blood becomes calcified and requires surgical correction to remove the otherwise-permanent lump and restore a normal contour to the head.

Newborns very frequently have a molded skull. Depending on the timing and severity of the pressure experienced during delivery, the shape and size of the uterus and positioning of the baby in the womb, the newborn can emerge with a variety of head shapes. The most common one that I see is a cone. If you’re thinking of a classic Saturday Night Live sketch right now, you’ve got the correct mental image.

Babies who are breech also have a distinct pattern of molding which involves a flattened and elongated top of the head because of pressure against the uterine wall. Abnormal positioning in the womb can also result in asymmetric molding of the head and facial structures like the jaw, nose and ear. Fortunately these pressure-induced and positional deformities usually resolve without intervention, often within a few days, but some are serious enough to require intervention and even surgical correction.

Why are the cranial bones of newborns so easily molded by the pressure of birth? This is a question I answer frequently for new parents and inexperienced medical students. The answer will segue us into the primary topic of this post, but before I discuss craniosynostosis, and the sadly unsurprising claims of some in the chiropractic community, a review of normal cranial anatomy is in order. (more…)

Posted in: Science and Medicine

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Should the FDA crack down on homeopathic “remedies”?

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:

oral-asthma-spray

Photo Credit Ryan Meylon

 

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following: (more…)

Posted in: Homeopathy, Politics and Regulation

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What Is Brain Death?

Of course, any story illustrating the issues surrounding brain death is going to be a sad and tragic tale. In December of 2013, Jahi McMath suffered bleeding complications following a tonsillectomy and tissue removal for sleep apnea. This resulted in a cardiac arrest with an apparent prolonged period of lack of blood flow to the brain. While her heart function was brought back, Jahi suffered severe brain anoxia (damage due to lack of oxygen) and was declared brain dead on December 12, 2013.

Jahi’s tragic story is not over, however, because her family refused to accept the diagnosis of brain death. They took legal action to keep the hospital from pulling life support, and eventually worked out a compromise where the family was able to remove Jahi to their own care. At present Jahi is apparently being cared for in an apartment in New Jersey, on a ventilator and fed through a feeding tube.

There is often some confusion as to what brain death actually is. The term is unfortunately often used to refer to a persistent vegetative state or other severe impairment of consciousness, but this is not accurate. Brain death refers to a complete lack of function of the brain, including basic reflexes in the brain stem. There is a specific protocol for declaring a person brain dead, requiring detailed examination by at least two attending physicians to document the complete absence of any brain function. If the slightest pupillary reflex is present, then the patient cannot be declared brain dead. The criteria also include provisions that there are no medications in the person’s system that can suppress neurological function and their core body temperature is sufficiently high (being too cold can also suppress neurological function).

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Posted in: Neuroscience/Mental Health

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