More employers are turning to direct primary care

Part of a series. Comprehensive primary care for employees means better employee health, greater productivity, less absenteeism and lower costs for both employee and employer. That is why some companies are making health care a company-wide strategic imperative rather than just a tactic as part of human resource cost management. Some are developing full service […]

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So doctor, who’s your boss?

As a relatively young physician, I always enjoy my conversations with the older members of our profession, who’ve seen so much change over the last few decades. I’m fascinated with their stories about how different the medical world was when they were residents, how treatments were so novel, and how they used solid clinical skills […]

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Why physician assistants are critical as health systems evolve

I have a long history with family medicine as my father was an early pioneer – heading up the family medicine program at Chicago’s Cook County Hospital in the 1970s. Even back then my dad was using physician assistants (PAs) — many of them former military medics in the Vietnam War era — who were […]

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Why #ILookLikeASurgeon resonates so powerfully

“A good surgeon has the eye of an eagle, the heart of a lion, and the hand of a woman …” – 15th century English proverb #ILookLikeASurgeon, a hashtag on Twitter and the movement it has inspired, has resonated deeply with me. I look like a surgeon. There is so much more behind this seemingly […]

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“Precision medicine”: Hope, hype, or both?

The cost to sequence a whole genome has been plummeting impressively since 2007.

I am fortunate to have become a physician in a time of great scientific progress. Back when I was in college and medical school, the thought that we would one day be able to sequence the human genome (and now sequence hundreds of cancer genomes), to measure the expression of every gene in the genome simultaneously on a single “gene chip,” and to assess the relative abundance of every RNA transcript, coding and noncoding (such as microRNAs) simultaneously through next generation sequencing (NGS) techniques was considered, if not science fiction, so far off in the future as to be unlikely to impact medicine in my career. Yet here I am, mid-career, and all of these are a reality. The cost of rapidly sequencing a genome has plummeted. Basically, the first human genome cost nearly $3 billion to sequence, while recent developments in sequencing technology have brought that cost down to the point where the “$1,000 genome” is within sight, if not already here, as illustrated in the graph above published by the National Human Genome Research Institute. Whether the “$1,000 genome” is truly here or not, the price is down to a few thousand dollars. Compare that to the cost of, for instance, the OncoType DX 21-gene assay for estrogen receptor-positive breast cancer, which costs nearly $4,000 and is paid for by insurance because its results can spare many women from even more expensive chemotherapy.

So, ready or not, genomic medicine is here, whether we know enough or not to interpret the results in individual patients and use it to benefit them, so much so that President Obama announced a $215 million plan for research in genomic mapping and precision medicine known as the Precision Medicine Initiative. Meanwhile, the deeply flawed yet popular 21st Century Cures bill, which passed the House of Representatives, bets heavily on genomic research and precision medicine. As I mentioned when I discussed the bill, it’s not so much the genomic medicine funding that is the major flaw in the bill but rather its underlying assumption that encouraging the FDA to decrease the burden of evidence to approve new drugs and devices will magically lead to an explosion in “21st century cures,” the same old antiregulatory wine in a slightly new bottle. Be that as it may, one way or the other, the federal government is poised to spend lots of money on precision medicine.

Because I’m a cancer doctor, and, if there’s one area in medicine in which precision medicine is being hyped the hardest, it’s hard for me not to think that the sea change that is going on in medicine really hit the national consciousness four years ago. That was when Walter Isaacson’s biography of Steve Jobs revealed that after his cancer had recurred as metastatic disease in 2010 Jobs had consulted with research teams at Stanford, Johns Hopkins, and the Broad Institute to have the genome of his cancer and normal tissue sequenced, one of the first twenty people in the world to have this information. At the time (2010-2011), each genome sequence cost $100,000, which Jobs could easily afford. Scientists and oncologists looked at this information and used it to choose various targeted therapies for Jobs throughout the remainder of his life, and Jobs met with all his doctors and researchers from the three institutions working on the DNA from his cancer at the Four Seasons Hotel in Palo Alto to discuss the genetic signatures found in Jobs’ cancer and how best to target them. Jobs’ case, as we now know a failure. However much Jobs’ team tried to stay one step ahead of his cancer, the cancer caught up and passed whatever they could do.

That’s not to say that there haven’t been successes. For instance, in 2012 I wrote about Dr. Lukas Wartman, a then recently minted oncologist who had been diagnosed with acute lymphoblastic leukemia as a medical student, was successfully treated, but relapsed five years later. He underwent an apparently successful bone marrow transplant, but recurred again. At that point, there appeared to be little that could be done. However, Dr. Timothy Ley at the Genome Institute at George Washington University decided to do something radical. He sequenced the genes of Wartman’s cancer cells and normal cells:

The researchers on the project put other work aside for weeks, running one of the university’s 26 sequencing machines and supercomputer around the clock. And they found a culprit — a normal gene that was in overdrive, churning out huge amounts of a protein that appeared to be spurring the cancer’s growth.

That was 2011 as well. Today, the sequence could have been done much more rapidly. In any case, Ley identified a gene that was overactive and could be targeted by a new drug for kidney cancer. His cancer went into remission. Wartman is now the assistant director of cancer genomics at Washington University.

The technology now, both in terms of sequencing and bioinformatics, has advanced enormously even since 2011. With it has advanced the hype. But how much is hype and how much is really hope? Let’s take a look. Also, don’t get me wrong. I do believe there is considerable promise in precision medicine. However, having personally begun my research career in the 1990s, when angiogenesis inhibitors were being touted as the cure to all cancer (and we know what happened there), I am also skeptical that the benefits can ever live up to the hype.

The origin of “precision” medicine

“Precision medicine” is now the preferred term for what used to be called “personalized medicine.” From my perspective, it is a more accurate description of what “personalized medicine” meant, given that many doctors objected to the term because they felt that every good doctor practices personalized medicine. Even so, “precision medicine” is no less a marketing term than was “personalized medicine.” If you don’t believe this, look at the hype on the White House website:

Today, most medical treatments have been designed for the “average patient.” In too many cases, this “one-size-fits-all” approach isn’t effective, as treatments can be very successful for some patients but not for others. Precision medicine is an emerging approach to promoting health and treating disease that takes into account individual differences in people’s genes, environments, and lifestyles, making it possible to design highly effective, targeted treatments for cancer and other diseases. In short, precision medicine gives clinicians new tools, knowledge, and therapies to select which treatments will work best for which patients.

If you think this sounds like what alternative medicine quacks (but I repeat myself) routinely say about “conventional medicine,” you’d be right. It’s not that precision medicine advocates don’t have a germ of a point, but they fail to put it this criticism into historical context. Medicine has always been personalized or “precision.” Its just that in the past the only tools we had to personalize our care were things like family history, comorbid conditions, patient preferences, and aspects of the patient’s history that might impact which treatment would be most appropriate. In other words, our tools to personalize care weren’t that “precise,” making our precision far less than we as physicians might have liked. Genomics and other new sciences offer the opportunity to change that, but at the cost of peril that too much information will paralyze decision making. Still, at its best, precision medicine offers the opportunity to “personalize” medicine in a science-based manner, rather in the “make it up as you go along” and “pull it out of my nether regions” method of so many alternative medicine practitioners, as well as the clinical trials tools to do it, such as NCI-MATCH. At its worst, precision medicine is companies jumping the gun and selling genomic tests direct to the consumer without having an adequate scientific basis to know what they mean or what should be done with the results.

In any case, up until 2011, the term “personalized” medicine tended to be used to describe a form of medicine not yet in existence in which the each patients’ unique genomic makeup would serve as the basis to guide therapies. Then, the National Academy of Sciences Committee issued a report, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease, which advocated the term “precision medicine” and differentiated it from “personalized medicine” thusly:

“Personalized medicine” refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not.” (PCAST 2008) This term is now widely used, including in advertisements for commercial products, and it is sometimes misinterpreted as implying that unique treatments can be designed for each individual. For this reason, the Committee thinks that the term “Precision Medicine” is preferable to “Personalized Medicine” to convey the meaning intended in this report.

As I said, “precision medicine” is a marketing term, but it’s actually a better marketing term than “personalized medicine” because it is closer to what is really going on. That’s why I actually prefer it to “personalized medicine,” even though I wish there were a better term. Whatever it is called, however, the overarching belief that precision medicine is the future of medicine has led to what has been called an “arms race” or “gold rush” among academic medical centers to develop precision medicine initiatives, complete with banks of NGS machines, new departments of bioinformatics and genomics, and, of course, big, fancy computers to analyze the many petabytes of data produced, so much data that it’s hard to have enough media upon which to store it and we don’t know what to do with it. Genomic sequencing is producing so much data that IBM’s Watson is being used to analyze cancer genetics. It’s not for nothing that precision medicine is being likened to biology’s “moon shot“—and not always in a flattering way.

So what is the real potential of precision medicine?

Complexity intrudes

I discussed some of the criticism of precision medicine when I discussed the 21st Century Cures Act three weeks ago. I’ll try to build on that, but after a brief recap. Basically, I mentioned that I was of a mixed mind on the bill’s emphasis on precision medicine, bemoaning how now, at arguably the most exciting time in the history of biomedical research, the dearth of funding means that, although we’ve developed all these fantastically powerful tools to probe the deepest mysteries of the genome and use the information to design better treatments, scientists lack the money to do so. I even likened the situation to owning a brand new Maserati but there being no gasoline to be found to drive it, or maybe having the biggest, baddest car of all in the world of Mad Max but having to fight for precious gasoline to run it. I also noted that I thought precision medicine was overhyped (as I am noting again in this post), referencing skeptical takes on precision medicine in recent op-eds by Michael Joyner in the New York Times, Rita Rubin in JAMA declaring precision medicine to be more about politics, Cynthia Graber in The New Yorker, and Ronald Bayer and Sandro Galea in the New England Journal of Medicine. Basically, the number of conditions whose outcome can be greatly affected by targeting specific mutations is relatively small, far smaller than the impact likely would be from duller, less “sexy” interventions, such as figuring out how to get people to lose weight, exercise more, and drink and smoke less. The question is whether focusing in the genetic underpinnings of disease will provide the “most bang for the buck,” given how difficult and expensive targeted drugs are to develop.

Over the weekend, there was a great article in the Boston Globe by Sharon Begley entitled Precision medicine, linked to DNA, still too often misses that gives an idea of just how difficult reaching this new world of precision medicine will be. It’s the story of a man named John Moore, who lives in Apple Valley, UT. Moore has advanced melanoma and participated in a trial of precision medicine for melanoma. His outcome shows the promise and limitations of such approaches:

Back in January, when President Obama proposed a precision medicine initiative with a goal of “matching a cancer cure to our genetic code,” John Moore could have been its poster child. His main tumors were shrinking, and his cancer seemed to have stopped spreading because of a drug matched to the cancer’s DNA, just as Obama described.

This summer, however, after a year’s reprieve, Moore, 54, feels sick every day. The cancer — advanced melanoma like former president Jimmy Carter’s — has spread to his lungs, and he talks about “dying in a couple of months.”

The return and spread of Moore’s cancer in a form that seems impervious to treatment shows that precision medicine is more complicated than portrayed by politicians and even some top health officials. Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure.

On the other hand, in the Intermountain study, after two years, progression-free survival in the group with advanced cancer treated using precision medicine techniques was nearly twice what it was in those who underwent standard chemotherapy, 23 months versus 12 months. Moore himself reports that with a pill he had one year of improved health and quality of life before his cancer started progressing again. It’s not yet clear in this trial whether this will translate into ain improvement in overall survival, the gold standard endpoint, but it’s a very promising start. It is, however, not a miraculous start.

Here’s the problem. I’ve alluded to it before. Cancer genomes are messed up. Really messed up. And, as they progress, thanks to evolution they become even more messed up, and messed up in different ways, so that the tumor cells in one part of a tumor are messed up in a different way than the tumor cells in another part of the tumor, which are messed up in a different way than the metastases. It’s called tumor heterogeneity.

Now enter the problem in determining which mutations are significant (commonly called “driver” mutations) and which are secondary or “just along for the ride” (commonly called “passenger” mutations):

But setbacks like Moore’s show that genetic profiling of tumors is, at this point, no more a cure for every cancer than angiogenesis inhibitors, which cut off a tumor’s blood supply, or other much-hyped treatments have been.

A big reason is that cancer cells are genetically unstable as they accumulate mutations. As a result, a biopsy might turn up dozens of mutations, but it is not always clear which ones are along for the ride and which are driving the cancer. Only targeting the latter can stop a tumor’s growth or spread.

Knowing which mutation is the driver and which are passenger mutations is so complicated that the Intermountain researchers established a “molecular tumor board” to help.

Composed of six outside experts in cancer genomics, the board meets by conference call to examine the list of a patient’s tumor mutations and reach a consensus about which to target with drugs. Tumor profiling typically finds up to three driver mutations for which there are known drugs, and the board reviews data on how well these drugs have worked in other patients with similar tumors.

And:

The next difficulty, Nadauld said, is that “the mutations may be different at different places in a tumor.” But oncologists are reluctant to perform multiple biopsies. The procedures can cause pain and complications such as infection, and there is no rigorous research indicating how many biopsies are necessary to snare every actionable mutation.

But a cancer-driving mutation that happens to lie in cells a mere millimeter away from those that were biopsied can be missed. Similarly, cancer cells’ propensity to amass mutations means that metastases, the far-flung descendants of the primary tumor, might be driven by different mutations and therefore need different drugs.

Or, as I like to say: Cancer is complicated. Really complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think it was tough to put a man on the moon, but that’s just peanuts to curing cancer, especially metastatic cancer. (Apologies to Douglas Adams.) Because of this, precision medicine as it exists now can lead to what Dr. Don S. Dizon calls a new kind of disappointment when genomic testing fails to identify any driver mutations for which targeted drugs exist because “discovery is an ongoing process and for many, we have not yet discovered the keys that drive all cancers, the therapies to address those mutations, and the tools to predict which treatment will afford the best response and outcome—an outcome our patients (and we) hope will mean a lifetime of living, despite cancer.”

Too true.

None of this is to say that precision medicine can’t be highly effective in cancer. I’ve already described one patient for whom it was. It’s also important to consider that even extra year of life taking a pill with few side effects is “not too shabby,” either, if the alternative is death a year sooner. Prolonging life with good quality is a favorable outcome, even if the patient can’t be saved in the end.

What is precision medicine, anyway?

As I thought about precision medicine during the writing of this post, one thing that stood out to me is that, although precision medicine is rather broadly defined, in the public eye (and, indeed, in the eyes of most physicians and scientists) its definition is much narrower. This narrower definition of precision medicine is the sequencing of patient genomes in order to find genetic changes that can be targeted for treatment, predict the response to therapy of various pharmaceuticals or dietary interventions, or predict disease susceptibility. In other words, it’s all genomics, genomics, genomics, much of it heavily concentrated in oncology. (I know I concentrated in oncology for this post because it is what I know best.) If you reread the definition from the National Academy of Sciences Committee report, you’ll see that precision medicine is defined much more broadly. Other similar definitions include metabolomics, environmental factors and susceptibilities, immunological factors, our microbiome, and many more, although even a recent editorial in Science Translational Medicine emphasized genomica more than other factors.

In fact, in the most recent JAMA Oncology, there are two articles, a study and a commentary, examining the effect of precision medicine in breast cancer. What is that “precision medicine”? It’s the OncoType DX assay, which is generically referred to as the 21 Gene Recurrence Score Assay.

Basically, this assay is used for estrogen receptor-positive (i.e., hormone-responsive) breast cancer that has not yet spread to the axillary lymph nodes. Twenty-one different genes related to proliferation, invasion, and other functions are measured, and an empirically derived formula used to calculate a “recurrence score.” Scores below 18 indicate low risk of recurrence as metastatic disease and insensitivity to chemotherapy. Patients with low scores generally receive hormonal therapy but not chemotherapy. Scores over 30 indicate high risk and greater sensitivity to chemotherapy. For such patients, chemotherapy and hormonal therapy are recommended. Patients who score in the “gray” area from 18-30 remain a conundrum, but clinical trials are under way to better define the cutoff point for a chemo/no chemo recommendation. In any case, this study indicates that the use of OncoType DX is associated with decreased use of chemotherapy but because of limitations in the Surveillance, Epidemiology, and End Results (SEER) data set with linked Medicare claims, it wasn’t clear whether this decline was in appropriate patients. In any case, there’s no reason why genomic tests (like the Oncotype DX test) that are rapidly proliferating shouldn’t be considered “precision medicine,” and they are in practice already. Contrary to the image of oncologists wanting to push that poisonous chemotherapy, OncoType DX was designed with the intent of decreasing chemotherapy use in patients who will not benefit. Imagine that.

In the end, I don’t really like the term “precision medicine” that much. It seems to be a term that reminds me, more than anything, of Humpty Dumpty’s famously scornful boast, “When I use a word, it means just what I choose it to mean—neither more nor less.” It’s a sentiment that definitely seems to apply to the term “precision medicine.” To me, when new tests or factors that predict prognosis or response to therapy or suggest which therapies are likely to be most effective are developed and validated, it’s an artificial distinction to link them to genomics, proteomics, or whatever, as well as “big data” and refer to them as “precision medicine.” To me, medicine that works is just “medicine.”

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Dr. Google is in the house. All hail Dr. Google!

Dr. Google has been the brunt of numerous jokes and various denigrations from the medical community for some time.  The most recent such offering to come to my attention was from Tanya Feke who seems to want Dr. Google sued for malpractice.  As one who was instrumental in the construction of the Internet, which allowed […]

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LITFL Review 195

Welcome to the 195th LITFL Review. Your regular and reliable source for the highest highlights, sneakiest sneak peeks and loudest shout-outs from the webbed world of emergency medicine and critical care. Each week the LITFL team casts the spotlight on the blogosphere’s best and brightest and deliver a bite-sized chuck of FOAM.

The Most Fair Dinkum Ripper Beauts of the Week

The Australia and New Zealand Intensive Care Society (ANZICS) have a superb YouTube page with lots of great lectures from their 2014 ASM being uploaded. Why not get started with the oration lecture from the legendary Simon Finfer? [SO]

The Best of #FOAMed Emergency Medicine

• New must=check-out FOAM site: Sketchy EBM from Anthony Crocco. Showcases short (5 min) videos discussing different aspects of EBM and on how to understand the literature. [AS]
• More great content from CORE EM on aortic dissection and syncope, with some great dogma addressed. [SL]
• Ever wish you could cardiovert a patient in SVT with a more effective Valsalva manoeuvre? At St Emlyus, Rick Body runs through a recent paper in the Lancet which might help. [SL]
• The latest FOAMcast is all about appendicitis. [MG]

The Best of #FOAMcc Critical Care

• In a traumatic arrest, can we use the absence of cardiac motion and pericardial effusion to determine whether an ED thoracotomy should be performed? Read the Pro from Rob Orman and EMRAP, and the rebuttal from Simon Laing and HEMTEMCast
• Josh Farkas from Pulmcrit discusses the use of high flow nasal cannulae in weaning from hypoxic respiratory failure. An interesting area without much data at present. Worth trying in your unit, perhaps? [SO]

The Best of #FOAMus Ultrasound

• Phillipe Rola presents a great case of ultrasound-guided hepatic abscess drainage at the bedside, on a ward. Respect. [SO]

The Best of #FOAMped Paediatrics

• WessexICS and the Team at TBL address the THAPCA-OH study which reported no difference in outcome for Therapeutic Hypothermia in Out-Of-Hospital Cardiac Arrest in kids. [CC]

The Best of #FOAMim Internal Medicine

• Latest in the Louisville Lecture series: on Cardiac tamponade with Dr Brown. [ML]

The Best of Medical Education and Social Media

• Ed Snelson guest posts on Rolobotrambles encourages trainers and learners to embrace the idea that using simulated failures can be a more valuable learning experience than a success. [CC]

News from the Fast Lane

• Check out another jammed packed edition of Research and Review in the Fast Lane 097 [ML]

Reference Sources and Reading List

• Emergency Medicine and Critical Care blog/podcast list
• LITFL Global Blogroll
• FOAMEM RSS feed syndication for global FOAM
• Twitter: #FOAMed – #FOAMcc – #FOAMtox – #FOAMped – #FOAMus – #FOAMim

Brought to you by:

• Anand Swaminathan [AS] (EM Lyceum, iTeachEM)
• Brent Thoma [BT] (BoringEM and Academic Life in EM)
• Chris Connolly [CC]
• Chris Nickson [CN] ( iTeachEM, RAGE, INTENSIVE and SMACC)
• Joe-Anthony Rotella [JAR]
• Kane Guthrie [KG]
• Mat Goebel [MG]
• Segun Olusanya [SO] (JICSCast)
• Simon Laing [SL] (HEFTEMCast)
• Tessa Davis [TRD] (Don’t Forget The Bubbles)
• Marjorie Lazoff [ML]

The post LITFL Review 195 appeared first on LITFL: Life in the Fast Lane Medical Blog.

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A neurosurgeon remembers the humanity in medicine

The vast majority of physicians enter medicine with an inborn sense of compassion. Junior residents, however, are the logistical workhorses of teaching hospitals — their north star is efficiency and they are measured largely on their capacity to “get things done.” The consequence is often a slide towards unwitting apathy. I, like all residents, have […]

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This story will show you how doctors are like sidewalk jugglers

The job of being a doctor can sometimes be like that of your favorite sidewalk juggler. It used to be that a good family doctor would have to show up in the clinic for a couple of hours, make a few house calls, and be available if anyone needed him while he played a round […]

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Why these medical interns did not die in vain

About a year ago, I wrote a piece on my blog called “How to Welcome Incoming Residents.” It was about my struggle with getting the right messaging, messaging about the reality of stress during residency and the necessity of incorporating self-care and outreach to others. This year at orientation, in addition to adding the great […]

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ND Confession, Part II: The Accreditation of Naturopathic “Medical” Education

Editors’ note: Britt Marie Hermies of NaturopathicDiaries.com returns to SBM to continue her series on naturopathy from the point of view of someone who has left that profession. If you missed it, the first post was “ND Confession, Part 1: Clinical training inside and out“. She has also contributed “The Wild West: Tales of a Naturopathic Ethical Review Board“.

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Photo by carnagenyc, some rights reserved

Prior to renouncing naturopathic medicine and starting NaturopathicDiaries.com, I knew very little about the accreditation of higher education in the United States. I had the impression that accreditation signified that a program or school had the endorsement of the federal government for quality standards. When I first looked into attending naturopathic programs, I remember learning that they are accredited by the U.S. Department of Education.

For me, and I assume for many others, accreditation of naturopathic doctoral programs stood for a medical education of high quality that delivered career prospects similar to those available to primary care physicians who earn an MD or DO. Accreditation also meant I could take out federally-subsidized loans to pay tuition and cover living expenses. Because the $40,000 annual tuition at naturopathic programs was (and still is) comparable to regular medical school, my perception of the validity of naturopathic education at accredited programs made me feel that I was investing in a secure career.

It wasn’t until I graduated from Bastyr University and had been in private practice for several years that I learned the truth about accreditation. Naturopathic programs are accredited by an organization dominated by naturopaths; this authority has been granted to them by the U.S. Department of Education, and they make up their own standards. Leaders in the naturopathic profession can then use the accreditation status of naturopathic programs to convince the public that naturopathic medicine is safe and effective and convince students that they are matriculating into a bonafide medical school.

Using the term accreditation to cultivate false credibility

When I was a naturopathic “medical” student at Bastyr, I was under the impression that my peers and I would be able to earn a salary similar to a primary care physician. Naturopathic medicine seemed to be on the up-and-up. I thought I would be eligible for jobs working right alongside physicians in hospitals, medical clinics, and other non-clinical organizations. One of my dreams was to bring naturopathic medicine to institutions involved with health policy, like the World Health Organization and U.S. Centers for Disease Control and Prevention. I thought my credentials from Bastyr would be accepted as forward-thinking medical training, which would give me a cutting-edge advantage over others who seemed stuck in some sort of old medical paradigm.

Why did I believe this fantasy?

I believed I was going to medical school. Printed on numerous pages of Bastyr’s website and over its promotional material are phrases that attractively support this outrageous story:

• recognized by the U.S. Department of Education
• internationally renown
• ground-breaking research
• rigorous curriculum
• state-of-the-art clinical training
• well respected, nationally recognized degree
• all the same basic sciences as a medical doctor
• naturopathic doctors are primary care physicians

Just by focusing on this marketing language, Bastyr makes it exceedingly clear that its graduates will become top-notch medical professionals. In fact, Bastyr claims to be “the Harvard of naturopathic medicine” and boasts that the Princeton Review ranked its naturopathic medicine program as “one of the 168 best medical schools” in the U.S. (At the time that edition of Princeton Review was published in 2011, there may have been less than 168 “conventional” medical schools in the U.S., which would likely put Bastyr dead last.)

The fact that naturopathic programs, like Bastyr, are actually accredited through the U.S. Department of Education makes other selling points about naturopathic medicine more believable.

In reality, career prospects for naturopathic doctors are poor. According to an alumni survey [PDF] conducted by the National College of Natural Medicine (NCNM) in 2010, the median net income of NCNM graduates who completed a naturopathic residency and used their ND degree was $60,000 (n=43). These 43 respondents were in practice between 29 years and less than one year. The financial potential is slightly worse for NCNM graduates who did not complete a residency: median income of $50,000 (n=141). These earnings are dismal for any career requiring a doctorate, which in the case for an ND student, results in a punishing financial situation to pay off huge student loans.

I just don’t understand how the naturopathic schools, like Bastyr, can tell students they will get such great medical training, while naturopathic doctors are earning so little money using their degree.

“Accreditation” associated rhetoric from the AANP and AANMC

Naturopathic professional organizations seem to rely on the U.S. Department of Education accreditation of ND programs to rationalize naturopathic medicine to public audiences. Usually, the rhetoric is focused on the following concepts: science-based, rigorous, and on-par with conventional medical school. There are two organizations responsible for broadcasting this information: the American Association of Naturopathic Physicians (AANP) and the Association of Accredited Naturopathic Medical Colleges (AANMC).

The AANP is the professional society of licensed naturopaths. One of the society’s main goals is to increase public awareness of naturopathic medicine, which includes promoting the notion that “naturopathic medicine is safe, effective, and cost-effective.” The AANP also states that it seeks to gain licensure for NDs in every state, so they “will be integrated into the nation’s health care system and be a part of all state and federal health care programs.” The AANP is responsible for major lobbying efforts at the federal and state levels.

The AANMC is an organization representing the seven approved naturopathic medicine programs in North America. This organization is different from the American Association of Medical Colleges (AAMC), which administers the MCAT and manages applications to medical schools and residencies. The AANMC appears to be more of a marketing and outreach organization for the naturopathic colleges. From its website, the AANMC’s mission is to “enhance the individual and collective success of member organizations in delivering high quality, innovative, and accessible naturopathic medical education and research.” The AANMC is located in Washington, D.C., and I can only assume this location helps them lobby for naturopathic issues at the federal government.

While each organization has a distinct purview, they are both active stakeholders in the naturopathic profession and lead the dissemination of information about naturopathic education and practice. I find their descriptions of naturopathic medicine misleading and often blatantly false.

In a 2011 lobbying document, the AANP describes the naturopathic degree as recognized by the U.S. Department of Education and Carnegie Institute as a “First-Professional Degree under Doctorate-Profession (Clinical), on par with MD and DO.” This document was used by naturopaths, including by myself as a student, to lobby for access to the same loans, scholarships, and residencies as MDs and DOs. I have seen recent lobbying material reproduce this description.

The Carnegie Institute, now called The Carnegie Classification of Institutions of Higher Education, is a group that categorizes schools and programs by the conferral of various post-secondary degrees. According to its website, the Carnegie Classification considers “degrees [to be] reliable artifacts of instructional activity” and works to categorize degrees for comparative purposes. If the AANP states that the Carnegie Classification of a naturopathic doctoral degree is in the same category as an MD or DO, one may very well believe that an ND degree is earned by learning a standard medical curriculum.

However, the ND degree is not classified as a first-professional degree by Carnegie Classification. Instead, it is classified as coming from a “special focus institution.” Institutions that also are classified as such include acupuncture schools, traditional Chinese medicine schools, theology programs, midwifery programs, and ITT Technical Institute.

First-professional degrees are considered comprehensive doctoral and professional programs that offer doctorates in the fields of humanities, social sciences, and Science, Technology, Engineering and Mathematics (STEM) fields, plus graduate degrees in professional fields such as business, engineering, law, and medicine. A doctoral degree in naturopathic medicine is not one of the first-professional degree categories classified by the Carnegie group.

As far as I can tell, the AANP has been lying to lawmakers about this supposed credential by the Carnegie Classification.

The AANMC is also complicit in putting out misinformation about naturopathic medicine. One of the most widely-disseminated bits of its propaganda is a chart showing a comparison [PDF] between the coursework hours of an MD student and an ND student in an “accredited” program in their first two years of training. One can make the following observations from the chart:

• ND students appear to take more hours of coursework in anatomy and embryology, biochemistry, physiology, and pathology
• MD students take more than five times as many hours in “systems-based courses” and more than twice as many hours in “other courses”
• ND students take more than twice as many hours in “clinical and modality training”
• MD students take 150 hours of coursework, and ND students take 151.5 hours

One could conclude from this chart that MD and ND programs have about the same number of coursework hours, and that differences in course categories shown on the chart might be explained by the different foci of the programs: natural medicine versus Western medicine.

Because the naturopathic programs are “accredited,” naturopathic medicine as a whole appears credible. Government accreditation can serve as a useful fact from which arguments against naturopathic medicine can be discredited and arguments in favor can be reinforced.

photo by Richard Lee, Some rights reserved

Facts about naturopathic education

In reality, naturopathic education at accredited programs is not rigorous nor science-based. In my first post on SBM, “ND Confession, Part 1: Clinical training inside and out“, I detailed the clinical training I received and showed that naturopathic students are trained in a whole bunch of pseudoscience and very little actual medicine.

The American Academy of Family Physicians (AAFP) nicely summarizes the drastic difference between medical physician training from that of a naturopath’s in this PDF document. In my opinion, the AAFP was being overly generous in their comparison by using numbers that appear to be falsely inflated by the AANP and AANMC. The breakdown of my naturopathic training hours were not available to the AAFP when this document was made. If it had been, naturopathic training would look even more deficient.

The 1,200 clinical training hours in primary care medicine that the AANP, AANMC, and naturopathic programs claim are received by ND students are nothing of the sort. The patients seen are often the worried well, who present with nonspecific and elusive symptoms with no real health consequences. If an ND student didn’t get a chance to train on a patient with a heart condition, for example, he or she could just make a short presentation to their peers and supervisor on said disease.

Using my transcript and student handbook, I calculated that I received less than 600 hours in “direct patient contact”; I was required to observe [PDF] a minimum of 350 patients and be the primary student clinician for only 175 of them! (The Council on Naturopathic Medical Education (CNME) now requires programs to provide at least 450 contacts and 225 of those as primary.)

Pre-clinical coursework at accredited naturopathic programs is also not so rigorous or science-based, though on paper ND credit hours match an MD or DO program. Indeed, naturopathic programs teach classes with the same titles as those in medical schools. Naturopathic classes, including basic sciences courses, are almost entirely taught by other naturopaths or other practitioners of alternative medicine, such as doctors of naprapathy. The pediatrics courses assign reading from anti-vaccine authors, like Bob Sears, and overall the reading load seems quite low for what would be expected from MD and DO students.

The accredited naturopathic curriculum also includes a large amount of pure pseudoscience, with the most glaring examples being three quarters spent on homeopathy, but also many quarters in old-timey hydrotherapy and “naturopathic” manipulation, which is essentially old-school osteopathic manipulation mixed with chiropractic.

I think it is worth noting the incredibly low entrance requirements for naturopathic students at Bastyr University. There is no required minimum GPA and there is no medical or graduate school entrance exam, such as the MCAT which is required for medical schools or the GRE which is required for most graduate programs. I even knew one ND student who never completed his bachelor’s degree!

While naturopathic organizations say what they do about the credibility of naturopathic education and clinical training, students are taking out huge amounts of debt to learn pseudoscience as though it is real medicine. If naturopathic programs were not accredited by the U.S. Department of Education, students would not be eligible for subsidized loans, and the schools would likely not remain financially sound. Without accreditation, the sea of false information would seem a lot more unmistakeable to the general public.

What is U.S. Department of Education accreditation?

The United States government has little authority over post-secondary institutions (colleges and universities). Individual states oversee some aspects of the education provided in post-secondary schools, but for the most part, schools maintain a large degree of autonomy. As a result, the quality of education provided at such institutions may vary.

The U.S. Department of Education does not directly accredit schools or programs. Instead, it delegates this task to private accrediting agencies.

Private accrediting agencies are educational associations that oversee the accreditation of institutions or programs. They have adopted criteria they deem appropriate for evaluating whether or not post-secondary institutions and programs can provide a decent education.

There is a national database of private accrediting agencies that are approved by the Secretary of Education. The entire list of requirements for approval is published in the Federal Registrar.

After the Secretary’s approval, the private accrediting agency is responsible for setting the standards for the institution or program seeking accreditation.

The CNME is the accrediting agency for naturopathic programs in North America. The CNME functions like the Liaison Committee for Medical Education (LCME), which accredits medical schools in North America. According to its website, the CNME “advocates for high standards in naturopathic education and its grant of accreditation to a program indicates prospective students and the public may have confidence in the educational quality of the program.” The CNME accreditation standards are described in the 2014 edition of the Handbook for Accreditation of Naturopathic Medicine Programs.

Accreditation reflects good organization, not good academics

Eligibility for accreditation has more to do with the administration, organization, and operation of an institution or program than education quality. A few requirements do directly impact curricula, but most do not.

The U.S. Department of Education states the purpose of accreditation is to help students and the public by:

• Verifying than an institution or program meets established standards
• Assisting prospective students in identifying acceptable institutions
• Creating goals for self-improvement of weaker programs and stimulating a general raising of standards among educational institutions
• Providing one of several considerations used as a basis for determining eligibility for Federal assistance

In other words, accreditation means prospective students and the public should be able to trust the institution’s description of its academic programs. The accredited agencies, like the CNME, are granted a great deal of responsibility because they are considered to be “reliable authorities as to the quality of education or training” offered by programs they accredit.

Because the U.S. Department of Education gives all of the accreditation standard-setting responsibility to private agencies, the standards that affect the educational curricula can be biased, possibly reflecting only the accrediting agency’s interests. Naturopathic medical programs are accredited by other naturopaths who run the CNME, which means that the curricula they pass meets only their own standards, and not widely-accepted, science-based standards of medical curricula.

Basically, naturopathic education is internally accredited.

Accredited conflict of interest?

The CNME was founded in 1978 by a naturopath Joseph Pizzorno. Pizzorno also founded Bastyr University in the same year and then served as the university’s president for the next 22 years. (He is also the co-author of the Textbook of Natural Medicine, which is widely used in accredited programs.)

Bastyr University’s founders were determined that their naturopathic program would be accredited. To achieve this goal, Pizzorno helped write the CNME standards for naturopathic programs [PDF] that would eventually be used to accredit Bastyr’s naturopathic program in 1987. (It is not clear from my research what the CNME was up to between 1978 and 1987.)

It seems to me, the CNME was formed purely out of aspirations for program accreditation and all that comes with that label, and not to ensure a high-quality medical education for naturopathic students.

Had accreditation been about guaranteeing a quality medical education, there was already an approved accrediting agency capable of assessing Bastyr’s medical program: the Liaison Committee for Medical Education (LCME, formed in 1942). But since Bastyr’s accrediting agency was formed by Pizzorno and the other founders in order to establish the standards for its own accreditation and its own brand of pseudomedicine, one can believe that Bastyr’s founders may have had something to hide from the LCME or other external scrutiny.

I find the CNME’s history rife with conflicts of interests. To be fair, the board of the CNME is currently composed of 11 members of which three are public members who are not naturopaths. However, when I looked into these public members, I found it fascinating that they all worked as administrators at chiropractic schools; two of them served on the Chiropractic Council of Education (CCE), the accrediting agency for chiropractic programs; one of them worked as an administrator for the University of Bridgeport, an accredited naturopathic program:

• Lansing Blackshaw, Ph.D. (nuclear engineering): Provost and Dean of Faculty at the University of Bridgeport from 1989-1995; Executive Vice President/Provost at New York Chiropractic College from 1995-2004; current member of the CCE appeals committee
• John P. Pecchia, M.B.A., C.P.A.: Currently Vice President for Business Affairs/CFO at Marnist College, which currently has an articulation agreement with New York Chiropractic College whereby students studying biology at Marnist can feed into NYCC’s chiropractic program; former Vice President for Financial Affairs and Treasurer at D’Youville College, which has a chiropractic program; former Vice President for Business Affairs and Treasurer at the New York Chiropractic College; former counselor since 2014 of the CCE
• Carl Saubert, Ph.D. (exercise physiology): former Vice President of Academic Affairs since 2014 of Logan University, a chiropractic school; former Vice President of Academic and Student Services at Cleveland College of Chiropractic; served in the Chief Academic Officers Group and the Institutional Assessment and Planning Administrators Group of the Association of Chiropractic Colleges

Why is it that the CNME has chosen only public members who had high-level administration positions at chiropractic institutions? Even though there are non-naturopathic, public members on the CNME board, these folks are currently or have been affiliated with yet another pseudoscientific, alternative medicine profession. This means that the entire CNME board comprises people who have vested interests in pseudoscience. Would the CNME board function differently if it had three non-woo woo medical doctors? I think, yes, but that scenario may very well be impossible.

The CNME has already run into trouble with the U.S. Department of Education. In January 2001, the CNME’s accreditation status was revoked due to a failure to respond appropriately to violations of standards at the Southwest College of Natural Medicine in Arizona. The CNME was not allowed to appeal the decision, but could reapply. In 2003, the CNME was once again approved by the Secretary as an accreditation agency for naturopathic medicine programs. In 2011, CNME was re-approved by the Secretary for the maximum term of five years. At the end of 2015, the CNME is coming up once again for review.

Naturopathic medicine is the fox guarding the hen house

Naturopathic program accreditation is a self-serving process that seems to be hiding something. As Jann Bellamy describes, this system results in the naturopathic curricula existing in a self-contained loop, divorced from mainstream medical standards. Naturopaths teach other naturopaths and unilaterally control the content of the program. There is no outside evaluation of course content taught at these schools, other than by its own accrediting agency. Although the CNME deems their accreditation review of the schools as external, they make a point to mention in the handbook [PDF] that:

The Council limits access to the evaluation team report to team members, Council members, the Council’s executive direction, and the chief administrative officer of the naturopathic medicine program, who is encouraged to distribute the report among the program’s community as the program considers appropriate.

Indeed, Bastyr’s webpage on accreditation provides PDFs of their regional accreditation self-study reports, but does not provide the reports prepared for CNME’s accreditation.

The sole purpose of the CNME, it seems to me, is to keep naturopathic schools accredited, rather than ensure a quality education for students who are under the impression that they are in a medical program to become real primary care physicians.

What’s to gain by becoming accredited?

Accreditation by an approved agency entitles the institution to establish eligibility to participate in Title IV programs. Programs authorized under Title IV of the Higher Education Act allow students in those programs to utilize federal aid services, such as loans, grants, and federal work study programs to pay for school. This is very important for institutions offering expensive degrees.

All accredited institutions and programs are entitled to Title IV programs, unless it is specifically noted otherwise. The CNME accreditation has such a note, stating:

Title IV Note: Accreditation by this agency does not enable the entities it accredits to establish eligibility to participate in Title IV programs.

Despite this note, naturopathic students at accredited schools are allowed to borrow absurdly large sums of money with unsubsidized student loans, Perkins loans, graduate PLUS, and private loans. I am still researching how this works, but I believe this is a more recent option for ND students.

According to the AANMC website:

ND students may qualify for up to $40,500 per three-term award period. The ND aggregate is $224,000.

It has been my understanding that these figures are based on what medical students typically need to borrow to attend medical school. The Yale School of Medicine website page on financial aid confirms how much its medical students can borrow:

Depending on your need…medical students may borrow $40,500 [per year].

The total amount Federal Direct Loan you may borrow as a graduate or professional student is $138,500 (medical students may borrow up to $189,125).

Although Bastyr calls itself an internationally-recognized school with a world-leading reputation in natural medicine and research, Bastyr is not Yale nor Harvard. It has no business charging students this much tuition for an education that consists of homeopathy, chiropractic techniques, botany, Chinese and Ayurvedic medicine, counseling, nutrition, and then a little medicine. Most of these other modalities, as NDs like to call them, are not shown to be efficacious and many can be harmful.

But even with high tuition fees, there is no way Bastyr can afford to provide a “standard medical curriculum” to its students. Using data from 2009, Jann Bellamy determined the following financial conundrum:

It takes between $75 and $150 million dollars to start a medical school. Average annual instructional costs per U.S. medical student is $73,544.41 (2009 cost). According to Bastyr’s website, it has 1,108 students currently enrolled in 22 degree-granting programs, including Ayurvedic (ancient Hindu medicine), acupuncture and oriental medicine. There are 462 students currently enrolled in Bastyr’s N.D. program. If these were medical students, the total annual instructional cost should be just under $33 million. Yet Bastyr’s total expenditures for educating over 1,000 students enrolled in 22 degree programs are just under $30 million per year.

Providing a rigorous, standard medical curriculum to students at Bastyr is not financially feasible, and it is clearly not happening. Students, like me, have been taking out hundreds of thousands of dollars in student loans to pay for an education that is masquerading as a credible medical degree. The public should be aware that this situation is not sustainable, and at some point, the cat will be let out of the bag.

The naturopathic profession needs to choose an identity

In my opinion, naturopathic schools and professional organizations are misleading the public, students, and politicians. They are capitalizing on misconceptions about accreditation status and using this term to suggest similarity to real medical programs. Accreditation through the auspices of the U.S. Department of Education enables naturopathic programs to stretch the truth on how they represent their medical curricula. On the one hand, the naturopathic profession claims they are a distinct form of primary care medicine, which can reduce costs and make us all healthier. On the other hand, it claims that naturopathic medicine is on-par with the standard medical curriculum and that NDs are trained just like medical doctors. Who are naturopathic doctors from accredited programs trying to be?

Rhetoric coming from the naturopathic profession is sticking. Naturopaths have been able to steadily gain licensure in the United States and Canada. In many states where they are already licensed, naturopaths are expanding their scopes of practice to include prescribing drugs and performing minor surgeries. Even mainstream medical and media sources online reproduce false information about naturopathic medicine:

• WebMD on Naturopathic Medicine:

a licensed naturopathic doctor (ND) attends a 4-year, graduate-level naturopathic medical school. He or she studies the same basic sciences as a medical doctor (MD).

• The University of Minnesota’s Center for Spirituality and Healing on Naturopathic Medicine:

Naturopathic practitioners have a Doctor of Naturopathic Medicine (ND) degree from a four-year graduate medical college with admission requirements comparable to conventional medical schools. The ND degree requires graduate-level study in conventional medical sciences, such as cardiology, biochemistry, gynecology, immunology, pathology, pharmacology, pediatrics, and neurology.

• A highly circulated article published in The Huffington Post by Michael Standclift, N.D. on Naturopathic Medicine:

Applicants to accredited naturopathic medical colleges need a bachelor’s degree and a competitive GPA in scientific prerequisites, just like applicants to “conventional” medical schools.

• The American Medical Student Association (AMSA) has a Naturopathic Advisory Board, which states that:

The Department of Education classifies the Naturopathic Doctor degree (ND) from CNME schools as a Doctor’s degree – Professional practice, along with MD and DO degrees.

These statements are just not true.

(Also, why does the AMSA have an ND advisory board? I know from my experience with outreach at Bastyr, that naturopathic students thought if they could get in with medical students who tend to be more open minded about CAM than practicing physicians, we would establish relations that would foster into stronger professional ties. I hope leaders at the AMSA read more about naturopathic medicine and reevaluate their openness to NDs.)

If naturopathic schools aim to convince politicians and the public that their medical programs are as good as standard medical schools, then naturopathic schools need to achieve accreditation from the Liaison Committee on Medical Education or invite external review from a special task force composed of real medical doctors and scientists. Nothing short of these options will convince me that Bastyr’s naturopathic program is on to some cutting-edge fusion of science and traditional medical wisdom.

One thing’s for sure. Naturopathy can’t be both real medicine and naturopathic medicine. Naturopaths need to stop confusing the public with misrepresentations and lies about naturopathic doctoral degrees and unanimously decide exactly who they are—medical doctors (MD) or not doctors (ND).

 

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Britt Marie Hermes is a naturopathy apostate: she practiced as a licensed naturopathic doctor in the United States for about three years, but then left the profession to pursue a science-based career. She is now a Master’s of Science student in Medical Life Sciences at the University of Kiel. Her research interests include inflammatory and genetic diseases, like psoriasis and Crohn’s. She lives in Kiel, Germany, with her husband, who is a doctoral candidate in archaeology, and their two dogs. She recently started the blog Naturopathic Diaries: Confessions of a Former Naturopath.

 

 

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(Dys-)Functional Medicine Comes to Dentistry

Now there is some functional dentistry!

The great philosopher Deepak Chopra wrote: “I do not believe in meaningless coincidences. I believe every coincidence is a message, a clue about a particular facet of our lives that requires our attention.” So when SBM author extraordinaire Jann Bellamy emailed me last week with an article about so-called “Functional Dentistry” with the comment “Blog fodder?”, I looked it over with interest and then promptly filed it away in my brain along with other things that I might get around to doing but probably won’t. The very next day, Dr. Clay Jones – also an SBM bloggist extraordinaire – asked me if I’d mind pinch-hitting and write a blog post for his upcoming Friday morning time slot while he was away on vacation.

Coincidence?

Personally, I find it more plausible that Jann and Clay secretly conspired to have me write this article in order to lure me into a rage spiral, than the notion that The Universe was sending me a message about a particular facet of my life that required my attention. But we are at Point B now, are we not? Regardless of whether the first domino was pushed by The Universe or by Jann and Clay, I suppose it is now incumbent upon me to share with the SBM readership yet another way where pseudo-scientific practices and deceptive branding and marketing tactics have trickled down from medicine into dentistry.

In this blog post, I will review what Functional Medicine (FM) is, what is wrong about it and what is right about it (yes, there are aspects of FM that are legitimate, if not admirable), and how it has infiltrated (some say contaminated) the field of dentistry. I think you’ll find that, when you pull back the curtains, the reality of FM as a “new and improved” medical/dental paradigm is vastly embellished and overstated, and the Great and Powerful Functional Medicine Oz is really just an old geezer pulling the levers of spin and hyperbole and pushing the buttons of pseudo-science.

What is Functional Medicine?

Functional Medicine, according to the Institute for Functional Medicine’s website:

addresses the underlying causes of disease, using a systems-oriented approach and engaging both patient and practitioner in a therapeutic partnership. It is an evolution in the practice of medicine that better addresses the healthcare needs of the 21st century. By shifting the traditional disease-centered focus of medical practice to a more patient-centered approach, functional medicine addresses the whole person, not just an isolated set of symptoms. Functional medicine practitioners spend time with their patients, listening to their histories and looking at the interactions among genetic, environmental, and lifestyle factors that can influence long-term health and complex, chronic disease.

Functional Medicine has been covered thoroughly in SBM by the late Wally Sampson, and the not yet late David Gorski and Steve Novella, among others; consequently, I need not delve too deeply into it here. However, a cursory unpacking of the above definition reveals a recurring logical fallacy, namely the Unstated Major Premise or Unstated Assumption. When it is claimed that FM “…addresses the underlying causes of disease,” or “Functional medicine practitioners spend time with their patients, listening to their histories and looking at the interactions among genetic, environmental, and lifestyle factors that can influence long-term health and complex, chronic disease,” the unstated premise is that “regular” doctors don’t do any of these things; they must be only symptom-oriented, not preventive in their outlook, and don’t take all of a patient’s personal, medical, and social factors into consideration before arriving at an invidualized course of action. This, of course, is false, and is what any good physician will do. I know mine does, and he does not identify as a Functional Medicine physician. This dubious technique is employed by most if not all CAM providers in an attempt to set themselves apart from the crowd.

Where does FM get it right?

Where FM gets it right is that, from all appearances, FM physicians as a whole tend to leave more appointment time for the history and physical exams, and claim to do a more thorough genetic, environmental, and lifestyle evaluation of their patients than a typical primary care physician. Functional Medicine practitioners emphasize healthy lifestyles, good nutrition, exercise, good sleep habits, smoking cessation, and so on, in addition to the normal comprehensive physical examination and lab tests, which is a good thing. This, of course, typically comes at a cost, as FM patients often (but not always) have higher out of pocket co-payments due to some tests and fees not being covered by medical insurance. However, patients state that they feel they are heard by their FM health care team, and the chances of some illness or condition being overlooked potentially could be reduced with the extra time spent and tests performed (although this hasn’t been demonstrated). Patients don’t want to wait hours in their “regular” doctor’s reception room, only to feel as though they are herded like cattle into cold examination rooms, then to wait another eternity until their nurse or physician gives them the proverbial seven minutes of their time before scribbling out a prescription that treats a symptom only. And while I hope you see through my above Straw Man scenario, you can see where the perception of individualized, caring medicine would be appealing to a significant percentage of the population, particularly those who are proactive and preventive in their health care decisions, those who may have a mistrust of “mainstream” medicine, and the worried well.

They are also right when they point out that the incidences of chronic diseases (such as cancer, heart disease, diabetes) have risen and that the health care costs associated with these diseases are burdening health care systems in many nations. Further, many if not most of these chronic disease are lifestyle related (smoking, poor sleep hygiene, sedentary habits, poor diet, etc.) and are thus preventable. Again, this is just good medical practice, and not a recent innovation of Functional Doctors.

Another area where FM is winning in the marketplace of perception and image is that they have branded themselves as progressive, a new paradigm in medicine. They throw around such enticing buzz- words and phrases as “powerful new operating system”, “empowerment”, “biochemical individuality”, “high touch/high tech”, et. al. while demonizing “conventional” medicine by describing it as “doctor centered”, “disease oriented”, “expensive”, and an “acute care model.” This message is indeed powerful, and has resulted in the integration (pardon the pun) of FM into such esteemed institutions as The Cleveland Clinic and George Washington University, and others. Even in my neck of the woods, The University of Kansas Medical Center has an Integrative Medicine department, where they boast of such quackery as vitamin C infusions and neurofeedback, the latter of which promises to “rebalance your brain.” Yes, those exact words are on the official University of Kansas Medical Center website. Sigh. Well, at least my alma mater still has the best college basketball program in the world.

What is wrong with Functional Medicine?

What is wrong with Functional Medicine is that it often promotes many CAM practices which have been shown to be of questionable therapeutic value, or outright ineffective. Reiki, acupuncture, chiropractic adjustments, “detoxification” programs, the aforementioned vitamin C infusions (unless you’re a bescurvied 18^th century sailor fresh off the boat), and many other CAM modalities are offered as “holistic patient centered” options (again, at a significant cost and not without risk). Individualized care based on biochemical and genetic markers have some merit in some situations, and I’ve no doubt that this will become more prevalent in the future as techniques improve and applications are demonstrated scientifically. For now, however, it is an idea whose time has not yet come on a broad scale, and it is disingenuous to state or imply otherwise.

The other area where FM is a bit misleading is in how they frame their message. As stated earlier, the concepts of treating the cause of disease instead of just the symptoms is the foundational basis of all health care. I’m sure that Mark Crislip, an infectious disease doc, actually tries to kill the bugs that cause his patients’ diseases; he doesn’t just treat the symptoms. Often, however, treating the cause isn’t possible. For example, with many auto-immune diseases, there is no cure for the underlying pathophysiology, therefore managing the patient symptomatically is the best modern medicine can do at the present time. Using deceptive rhetoric and logical fallacies to their advantage, they frame FM as cutting edge and (ironically) science based, while portraying the mainstream medical community as closed minded, archaic, and behind the times.

Functional Dentistry – Coming to a theatre near you

Not wanting to feel left out, some dentists who have for years called themselves “biologic” or “holistic” dentists decided that a cool new word would really help separate themselves from the “ordinary” dentists who recommend such poisons as fluoride and amalgam fillings. Originally, “alternative” was the word of choice, but over time it grew stale and was subsequently replaced by “complementary”, a kinder and gentler term that implied a sort of truce between science based medicine/dentistry and non-traditional practices. After a while, the term “integrative” became fashionable, as complementary and alternative medicine attempted to insert itself into mainstream medicine. Thanks to promoters like Mehmet Oz, Andrew Weil, Deepak Chopra, and Joltin’ Joe Mercola, integrate it did. Not only into university-based medical centers, as mentioned above, but into private medical and dental practices worldwide. Within the past couple of years, some dentists have seized upon the “Functional” moniker and have co-opted it for their own use. Mind you, for these dentists, there has been no change in philosophy or standard of care from when they were only bioholisticompleternative dentists, it is a marketing/branding term only, which they presumably hope will help their websites’ Search Engine Optimization.

To date there are no “official” Functional Dentistry organizations, although I wouldn’t be surprised if one was founded in the near future. However, many individual dentists’ websites blatantly ride FM’s coattails. One dentist’s website states:

Functional Medicine Based Dentistry is the application of the principles and practices of Functional Medicine with the practice of the art and science of Dentistry. Philosophical differences exist today between traditional Evidence-Based Dentistry and Biological Dentistry, which have an impact on all patients and their oral and systemic health. Functional Medicine believes that a patient’s history, physiology, and lifestyle are fundamental factors when evaluating a patient’s health. Examination and interpretation of a patient’s individual biochemistry and genetics can give clues and hence better understanding of a patient’s chronic disease.
When we apply these concepts in the course of dental examination, diagnosis and treatment, the “one size fits all” philosophy of standard American dentistry becomes outdated and dentists transform from “molar mechanics” to true “physicians of the mouth.”
(emphases in the original)

Just like in Functional Medicine, statements like the above are disingenuous and fairly drip with the Unstated Assumption fallacy. As a non-Functional dentist, I can honestly say that I too believe that a patient’s history, physiology, and lifestyle are fundamental factors when evaluating their oral health. In fact, I know of no dentist who believes otherwise. Further, “examination and interpretation of a patient’s individual biochemistry” is a bit vague; while there are some useful genetic and salivary tests (when indicated) that are available in dentistry, they shouldn’t necessarily be utilized routinely and indiscriminately as screening tools until the evidence justifies it. And last, there is no such thing as a “one size fits all” approach to dentistry. Every person, every mouth, every situation is unique, and every prudent dentist takes all of these factors into consideration when determining a course of action for a patient, involving them in their treatment decisions. This is in our code of ethics and is not the domain of any one particular brand of dentistry.

Conclusion: Choose substance over marketing

All that said, most “alternative” or “functional” dentists are very conscientious dentists who sincerely want the best for their patients. If your dentist claims to be “holistic” or “functional” or “biologic”, you may want to put your antennae up if you are a science-based consumer of health care, but don’t throw the baby out with the bath water and summarily reject him/her. He or she may be a fantastic, science based dentist who is merely adapting the cloak of Functional Medicine Based Dentistry because they believe they are indeed “whole person” centered, want to appear to be cutting edge and progressive, and to gain a marketing advantage on their competition. There’s nothing wrong with that per se. To that end however, never hesitate to ask for good evidence if your dentist recommends something that seems “non-traditional.” The Center for Evidence Based Dentistry is a great resource for patients and health care providers alike. By being aware of what labels are being employed by physicians and dentists, what these labels mean, and why they are being used will help health care consumers make sound, science based decisions for themselves and their loved ones.

 

 

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Is there a natural treatment for tinnitus?

Ear Tone is a supplement claimed to help tinnitus. Does it work?

“Why do you bother blogging?” asked a colleague. “You take hours of your personal time to write, and you do it for free. You’re not even getting any citations for all that work.” I admit I found the questions a bit surprising. True, you won’t find SBM posts abstracted in PubMed. But I’m writing for an entirely different audience. I blog for the same reason that I became a pharmacist: to help people use medicines more effectively. Practicing as a pharmacist is one way to do that. In that setting, you’re helping one patient at a time. And seeing how your advice and support can enhance someone’s care is tremendously gratifying.

I see blogging as another form of pharmacy practice, hopefully with similar effects. Yes I do get regular hate mail, and the occasional legal threat, but there’s also gratitude for a post that resonated with someone, or helped them make better decisions about their health. When Google searches don’t give answers, I get questions — too many to answer. Today’s post is based on a request for help from someone seeking advice on natural supplements to treat ringing in their ears. They have tinnitus, and they’re frustrated at the limits of what their physician (and medicine) can do. They sent me an advertisement for a supplement called Ear Tone, a natural health product which is advertised (and approved) to provide tinnitus relief. Can natural supplements do what conventional medicine cannot?

When buying supplements, the deck is stacked against consumers

One of my recurring (and favourite) blog topics is evaluating the evidence supporting dietary supplements. Not only is it an opportunity to look at a specific medical condition, it’s a tool to illustrate how to use a science-based approach to answer medical questions. Supplements are also the perfect subject to illustrate the consequences of weak, ineffective health regulation, and how this approach harms consumers. Nowhere else in medicine is there an area that’s in such need of consumer advocacy and patient protection. While regulations will differ between countries, supplements tend to get a “pass” by most governments. This pass (which is usually in the form of special regulations), usually excludes supplements from the licensing requirements (and evidence standards) that applies to conventional drug products. It will vary somewhat depending on what country you live in, but in countries like the USA and Canada, this is what you’ll find:

• There are few limits on what can be legally sold as a supplement or natural health product.
• There are few limits on the health claims that can be made about these products.
• There are few, if any, requirements to directly test supplements for safety.
• There are often no requirements to test supplements for actual effectiveness.
• Pharmacies and other retailers sell supplements alongside regular drug products, without distinguishing them.

The result is a marketplace that is a boon to supplement makers, but puts consumers at a considerable disadvantage. Worse, many health professionals also give supplements a pass, failing to hold them to the same evidence standards as drug products. Pharmacy shelves are becoming the “Wild West” of healthcare, where evidence-supported products are sold alongside those that are either unproven, or even worse, completely ineffective (e.g. homeopathy).

Supplement manufacturers exploit difficult-to-treat conditions, like tinnitus

When medicine can’t deliver an obvious cure, or where a medical condition is poorly understood, you create the breeding ground for alternative medicine remedies. Steven Novella described their characteristics in a past post:

• conditions that have subjective symptoms (think fake diseases, like adrenal fatigue)
• conditions that may vary naturally, over time (e.g. supplements to treat fertility concerns; or pain)
• illnesses with a substantial psychological condition (e.g. anxiety)

Tinnitus is one of those conditions.

Tinnitus is not just a ringing in the ears

Tinnitus is the perception of noise when there is no external cause. While it’s typically thought of as ringing, it can also be perceived as buzzing or hissing. Tinnitus is common, affecting up to 15% of individuals, depending on your age. While rarely serious, tinnitus can significantly interfere with quality of life. Tinnitus can be caused by age, loud noise (from construction equipment to loud music), ear wax blockage, and ear bone changes. (Sixties rock icon Pete Townsend is a famous tinnitus sufferer, which he attributes to years of listening to headphones.) Many medications are associated with tinnitus, as can other medical conditions, such as cardiovascular disease. Consequently, every tinnitus case needs to be medically evaluated, to search for any underlying causes and to rule out more serious medical conditions. In some cases a clear cause for tinnitus cannot be found, and it becomes a chronic condition. Reducing the impact and effects becomes the treatment goal.

The management of tinnitus focuses first on any underlying causes or conditions. While there is no cure, there are medical treatments that can be effective, including:

• addressing hearing loss with products like hearing aids
• treating depression or anxiety which may be identified in patients with tinnitus
• using behavioral therapies such as tinnitus retraining (reducing awareness of the noise), cognitive behavioural therapy, or masking (low-level noise) to drown out the sound

Overall, these therapies are only modestly effective. There is no magic bullet. While numerous vitamins, minerals and supplements have also been tested, there are no studies that suggest that any supplement provides a meaningful improvement.

What is Ear Tone?

Ear Tone is a combination herbal remedy that’s advertised widely and sold in many pharmacies for the treatment of tinnitus. It’s manufactured by New Nordic, a Swedish supplement manufacturer that has been criticized in the past for making misleading claims about its product. The manufacturer makes the following claim:

Ear Tone is a new product that is based on new research, showing significant results in treating tinnitus naturally. Ear Tone works by supplying the ear with the right nutrients while promoting peripheral blood circulation.

According to the manufacturer’s website, each Ear Tone tablet contains:

• Ginkgo biloba leaf: [50:1]: 100 mg
  • 24 % Flavonoid glycosides
  • 6 % Terpene lactones
• Magnesium (as magnesium oxide): 532 mg
• Pinus pinaster (Maritime pine bark): 50 mg
  • labelled as 95 % Proanthocyanidins

The recommended dose is two tablets per day, which gives a monthly cost of about $30.

Do the ingredients in Ear Tone help tinnitus?

The first ingredient, ginkgo, has a long history of use as a natural medicine, but there’s no clear evidence that ginkgo is effective for any medical condition. Presumably included here to enhance blood circulation in the area, studies have shown mixed results for the treatment of vascular disease and while it has been studied specifically for tinnitus, results have been mixed. Overall, there’s no convincing evidence it actually has any meaningful benefit with tinnitus. A Cochrane review concluded the same, noting:

The limited evidence does not demonstrate that Ginkgo biloba is effective for tinnitus when this is the primary complaint.

The second ingredient is magnesium, supplied as magnesium oxide, and according to the manufacturer is included because it “protects the nerves in the inner ear and promotes an electrolyte balance in its hair cells.” While magnesium is an abundant ion in the body, there is no published evidence with magnesium supplements to suggest it protects nerves or promotes electrolyte balance in hair cells. I found a single open-label study of magnesium supplementation and tinnitus published in 2011 that suggested a modest beneficial effect. Given it was neither randomized nor blinded, it’s hard to see this as evidence as efficacy.

The third ingredient is literally the bark from a pine tree, in this case, the Maritime pine. There’s one study with a branded version of pine bark (“Pycnogenol”) that was evaluated in a pilot study for effectiveness against tinnitus. Over four weeks, patients on the supplement were noted to experience an improvement in symptoms as well as cochlear blood flow. It’s not clear if the study was blinded or randomized, however, and the authors note:

More studies should be planned to better evaluate the pathology and potential applications of Pycnogenol in a larger number of patients who are currently without a real therapeutic solution.

There’s also a 2014 study with Pycnogenol which was a registry — a real-world evaluation that concluded the product may offer benefit in Meniere’s disease and tinnitus. This is nonrandomized, uncontrolled, and therefore unconvincing data. Before we can conclude this product offers actual benefits, it needs to be evaluated in prospective, blinded, and controlled trials.

So there’s little evidence Ear Tone works.

What are the risks of gingko and pine bark?

What about risks? There are few case reports of serious harms with ginkgo or with pine bark, but that’s complicated by poor data collection — since there are few trials and only limited real-world surveillance, the long-term safety is unclear. There is the risk that this combination of products could magnify or interfere with the action of drugs that affect blood coagulation. Its possible effects on other drugs are not well understood.

I don’t see enough evidence of effectiveness here to recommend Ear Tone, but ultimately this is a personal decision. Given what we know (and don’t know) about the efficacy and safety, some may decide it’s worth a try, especially if they’re experiencing poor quality of life from tinnitus. If that was my patient’s choice, I’d want to ensure that their other medications had been reviewed for any possible interactions. I’d also encourage any user to try to objectively measure whether or not they experience any relief. From reports online, many have not found it helpful.

Health Canada’s recommendations aren’t based on evidence

Despite the limited evidence suggesting that Ear Tone has any beneficial effects, Health Canada has approved Ear Tone with the following wording:

Recommended Use or Purpose:
Helps to reduce the perception of tinnitus in the ears. Helps to support peripheral circulation.

Health Canada has concluded the product is effective despite the fact that there is no published evidence suggesting this particular combination of ingredients has even been formally tested. This is the double-standard for supplements at work — approval from the regulator without the requirement to actually test your product for safety or effectiveness.

What’s the bottom line for consumers with tinnitus?

Tinnitus is an often-chronic condition for which we lack a good understanding of the causes and treatments. While there are some therapies that can help minimize symptoms, there are no cures.

Despite the hype, the anecdotes, and the marketing, there are no supplements for tinnitus that have been shown to offer any meaningful benefit. It would be wonderful if there really were a magic herb (or combination of herbs and minerals, like Ear Tone) that you could grind up, put in capsules or tablets, and expect relief. But that’s not realistic. This doesn’t stop manufacturers from making claims, or regulators like Health Canada from agreeing, that products like Ear Tone are “effective” because they’ve squeaked over a lowered evidence bar for natural health products.

Learning there are no easy solutions or cures for tinnitus can be difficult to accept, especially when tinnitus significantly impairs your quality of life. Supplement marketers know this all too well, and will likely continue to market unproven supplements for tinnitus that lack good evidence of efficacy.

 

 

via Medicine Joint Channels