Social Network Medicine is a Bad Idea

I like social networking as much as the next person and as an "early
adopter" medical blogger no one can accuse me of not being dialed
into "The World Wide Web" or "The Facebook". But my embracing of mobile
health stops when I read about a new start up that was mentioned in the
New York Times this week. HealthTap is a concept that I hope doesn't
make it. HealthTap is a start-up based in

ICD-10 To Be Delayed Indefinitely--Never Mind!

After years of telling us they are serious this time and everyone in the health care system had better be ready on time to implement the new disease coding system, CMS said today the whole project is going to be delayed indefinitely.The new ICD-10 system requires payers and providers to convert from the old system of 13,000 codes to the new system of 68,000 codes.All payers and providers were

First Aid for Car Crashes

A big crash happened right in front of me today while I was at a stop
light. The sound of crunching metal and screeching brakes is truly
frightening and it was clear help would be needed. I crossed the
intersection and parked my car and ran across the street to see if I
could help. Surprisingly, the man driving the car that was hit was not
hurt. The young woman in the car that struck him

Dark Spots in Eye and Skin

I must admit, being a physician, I notice unusual skin changes where
ever I go and I'm fascinated with the variety of conditions I see.
Thanks to the Captain of our snorkeling trip in Hawaii for allowing
these photos of his congenital condition called Nevus of Ota.
(Originally described by Ota and Tanino in 1939). As you can see, there
is a gray or blueish patch on the skin around the eye

Qnexa, the Latest FDA Approved Obesity Drug

There are very few obesity drugs currently approved for use in the US-- not because effective drugs don't exist, but because the FDA has judged that the side effects of existing drugs are unacceptable. 

Although ultimately I believe the most satisfying resolution to the obesity epidemic will not come from drugs, drugs offer us a window into the biological processes that underlie obesity and fat loss.  Along those lines, here's a quote from a review paper on obesity drugs that I think is particularly enlightening (1):
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Speaking at AHS12

I'll be giving a 40 minute presentation at the Ancestral Health Symposium this summer titled "Digestive Health, Inflammation and the Metabolic Syndrome".  Here's the abstract:

The “metabolic syndrome” is a cluster of health problemsincluding abdominal obesity, insulin resistance, low-grade inflammation, highblood pressure and blood lipid abnormalities that currently affects one thirdof American adults.  It is thequintessential modern metabolic disorder and a major risk factor for diabetes,heart disease and certain cancers.  Thistalk will explore emerging links between diet, gut flora, digestive health andthe development of the metabolic syndrome. The audience will learn about factors that may help maintain digestiveand metabolic health for themselves and the next generation.

Excessive fat mass is an important contributor to the metabolic syndrome, but at the same level of body fatness, some people are metabolically normal while others are extremely impaired.  Even among obese people, most of whom have the metabolic syndrome, about 20 percent are metabolically normal, with normal fasting insulin and insulin sensitivity, normal blood pressure, normal circulating inflammatory markers, and normal blood lipids.

What determines this?  Emerging research suggests that one factor is digestive health, including the bacterial ecosystem inside each person's digestive tract, and the integrity of the gut barrier.  I'll review some of this research in my talk, and leave the audience with actionable information for maintaining gastrointestinal and metabolic health.  Most of this information will not have been covered on this blog.

The Ancestral Health Symposium will be from August 9-12 at Harvard Law School in Boston, presented in conjunction with the Harvard Food Law society.  Tickets are currently available-- get them before they sell out!  Last year, they went fast.

See you there!

Food Reward: Approaching a Scientific Consensus

Review papers provide a bird's-eye view of a field from the perspective of experts.  Recent review papers show that many obesity researchers are converging on a model for the development of obesity that includes excessive food reward*, in addition to other factors such as physical inactivity, behavioral traits, and alterations in the function of the hypothalamus (a key brain region for the regulation of body fatness).  Take for example the four new review papers I posted recently by obesity and reward researchers:
Read more »

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for evidence-based medicine (EBM) , that is, medicine based on judicious use of the best available evidence from clinical research, critically reviewed and derived from systematic search, combined with biomedical knowledge and understanding of patients' values and preferences.  However, EBM risks being turned into pseudo-evidence based medicine due to systematic manipulation and distortion of the clinical research evidence base.  Dr Wally Smith wrote about pseudo-evidence based medicine, which he defined as "the practice of medicine based on falsehoods that are disseminated as truth," in the British journal Clinical Governance (Smith WR. Pseudoevidence-based meidicne: what it is, and what to do about it. Clinical Governance 2007; 12: 42-52. Also see this post).  

Now it appears that this issue is causing concern in the Cochrane Collaboration, the main voluntary international group promoting EBM.  An article from December, 2011 in the Indian Journal of Medical Ethics outlined why we need to question the trustworthiness of the global clinical evidence base.  (See Tharyan P. Evidence-based medicine: can the evidence be trusted.  Ind J Med Ethics 2011; 8: 201-207.  Link here.)  It merits further review.

The Role of Vested Interests

Dr Tharyan, its author, emphasized that a major threat to the integrity of the clinical research data base is the influence on clinical research of those with vested interests in marketing particular products, e.g., drugs, devices, etc.

The motives for conducting research are often determined by considerations other than the advancement of science or the promotion of better health outcomes. Many research studies are driven by the pressure to obtain post-graduate qualifications, earn promotions, obtain tenured positions, or additional research funding; many others are conducted for financial motives that benefit shareholders, or lead to lucrative patents.

The Importance of Pervasive Conflicts of Interest

Early on, the author discussed how the distortion of the clinical research data base arises from the pervasive web of conflicts of interest in medicine and health care:

This hijacked research agenda perpetuates further research of a similar nature that draws more researchers into its lucrative embrace, entrenching the academic direction and position statements of scientific societies and academic associations. Funders and researchers are also deterred from pursuing more relevant research, since the enmeshed relationship between academic institutions and industry determines what research is funded (mostly drugs at the expense of other interventions), and even how research is reported; thus hijacking the research agenda even further away from the interests of science and society.

The article then goes on to show how the influence of vested interests may distort the design, implementation, analysis, and dissemination of research.

Distortion of Research Design and Implementation

The Research Question

Dr Tharyan noted

The majority of clinical trials conducted world-wide are done to obtain regulatory approval and a marketing licence for new drugs. These regulations often require only the demonstration of the superiority of a new drug over placebo and not over other active interventions in use. It is easier and cheaper to conduct these trials in countries with lower wages, lax regulatory requirements, and less than optimal capacity for ethical oversight. It is therefore not surprising that the focus of research does not reflect the actual burden of disease borne by people in the countries that contribute research participants, nor address the leading causes of the global burden of disease. Some 'seeding' trials, conducted purportedly for the purpose of surveillance for adverse effects, are often only a ploy to ensure brand loyalty among participating clinician-researchers.

Insufficient Sample Size

The article stated,

Many trials do not report calculations on which the sample size was estimated, often leading to sample sizes insufficient to detect even important differences between interventions (for primary, let alone secondary outcomes)

I would add that such small trials are particularly bad at detecting important adverse effects of the interventions being promoted.

Excessively Stringent Enrollment Criteria

As Dr Tharyan wrote,

Most RCTs funded by industry and academia are designed to demonstrate if a new drug works, for licensing and marketing purposes. In order to maximise the potential to demonstrate a 'true' drug effect, homogenous patient populations; placebo controls; very tight control over experimental variables such as monitoring, drug doses, and compliance; outcomes addressing short term efficacy and safety; and methods to minimise bias required by regulatory agencies are used to demonstrate if, and how, the drug works under ideal conditions.

The problem is that very few patients in clinical practice resemble those enrolled in such trials, so the generalizability of the trials' results is actually dubious. Ideally, clinicians practicing evidence-based medicine could refer to trials that include patients similar to those for whom they care.

Practical or pragmatic clinical trials are designed to provide evidence for clinicians to treat patients seen in day-to day clinical practice, and evaluate their effectiveness under 'real-world' conditions. These trials use few exclusion criteria and include people with co-morbid conditions, and all grades of severity. They compare active interventions that are standard practice, and in the flexible doses and levels of compliance seen in usual practice. They utilise outcomes that clinicians, patients, and their families consider important, such as satisfaction, adverse events, return to work, and quality of life). Recommendations exist on their design and reporting , but such trials are rare.

Comparisons to Placebo, not the Other Interventions Clinicians Might Realistically Consider

Per the article,

Industry sponsored trials rarely involve head-to head comparisons of active interventions, particularly those from other drug companies, thus limiting our ability to understand the relative merits of different interventions for the same condition.

The result may thus be a number of studies showing particular interventions appear to be better than nothing, but few if any studies that would help clinicians decide which intervention would be best for a particular patient.

Inappropriate Comparators

However,when studies are done comparing the intervention of interest to other active interventions, the details of the choice of comparators are often managed so that the comparators are likely to appear to be worse.

Even if active interventions are compared in industry-sponsored trials, the research agenda has devised ways in which the design of such trials is manipulated to ensure superiority of the sponsor’s drug. If one wants to prove better efficacy, then the comparator drug is a drug that is known to be less effective, or used in doses that are too low, or used in non-standard schedules or duration of treatment. If one wants to show greater safety, then the comparator is a drug with more adverse effects, or one that is used in toxic doses. Follow up, also, is typically too short to judge effectiveness over longer periods of time.

Meaningless Outcomes

A favorite tactic used in the design of trials influenced by vested interests is to choose outcomes that are likely to show results favorable to the product being promoted, but have no meaning for patients or clinicians. There are three ways this is commonly done.

The first is to use rating scales that are very sensitive to small perturbations, but not meaningful in terms of how patients feel or function:

The choice of outcome measures used often ensures statistically significant results in advance, at the expense of clinically relevant or clinically important results. Outcomes likely to yield clinically meaningless results include the use of rating scales (depression, pain, etc.). These scales yield continuous measures usually summarised by means and standard deviations, rather than the dichotomous measures clinicians use such as: clinically improved versus not improved. These rating scales, however extensively validated, are hardly ever used in routine clinical practice. A difference of a few points on these scales results in statistically significant differences (low p values), that have little clinical significance to patients.

Another is to use surrogate outcomes,

Image Challenge

What is the diagnosis? You be the doctor. This 32 year old man wonders
about the raised spots on his testicles. They are non-tender and non
itchy. (click on the image for a close-up view) 1. Beta-galactosidase
deficiency 2. Fordyce's angiokeratomas 3. Radiation dermatitis 4.
Scabes 5. Varicocele The answer will be posted tomorrow so be sure to
check back. Make your guess in the

Goal Play Leadership Lessons

My blog friend, Paul Levy, former CEO at Beth Israel Deaconess Medical
Center in Boston, was the first hospital CEO to create a blog ("Running
a Hospital") that became famous for it's honesty and look into a
hospital's inner workings. He is now embarking on the next chapter of
his life with the publication of his new book," Goal Play - Leadership
Lessons from the Soccer Field." Who knew

How Doctors Get Paid

Medical economics is more confusing than "advanced derivatives" and the
entire banking industry collapse. Have you ever wondered how doctors
get paid? I will try to give a brief tutorial. Consider it "Doctor
Reimbursement 101". First of all, all payments made by Medicare or
Insurance companies are based on a weird rating called the Relative
Value Scale. A group of mainly specialty

Boing!

I just had a featured article published on Boing Boing, "Seduced by Food: Obesity and the Human Brain".  Boing Boing is the most popular blog on the Internet, with over 5 million unique visitors per month, and it's also one of my favorite haunts, so it was really exciting for me to be invited to submit an article.  For comparison, Whole Health Source had about 72,000 unique visitors last month (200,000+ hits).

The article is a concise review of the food reward concept, and how it relates to the current obesity epidemic.  Concise compared to all the writing I've done on this blog, anyway.  I put a lot of work into making the article cohesive and understandable for a somewhat general audience, and I think it's much more effective at explaining the concept than the scattered blog posts I've published here.  I hope it will clear up some of the confusion about food reward.  I don't know what's up with the image they decided to use at the top. 

Many thanks to Mark Frauenfelder, Maggie Koerth-Baker, and Rob Beschizza for the opportunity to publish on Boing Boing, as well as their comments on the draft versions!

For those who have arrived at Whole Health Source for the first time via Boing Boing, welcome!   Have a look around.  The "labels" menu on the sidebar is a good place to start-- you can browse by topic.

Will the Pace of Innovative Change Overtake the Financial Imperative to Slash Spending?

I thought it was worth passing along the comments by Jim Tallon, president of New York's United Hospital Fund, in a recent post.Tallon reflected on an international meeting he attended with health care leaders from a number of industrial nations--"nations whose health care systems, indeed underlying philosophies, ranged from market orientation through hybrids to government authority:" "Across

Electronic Health Records Don't Cut Costs

A new study was published in the Journal Health Affairs that reports
computerized patient records are unlikely to cut health care costs and
might encourage doctors to order more expensive tests. Save your
research dollars, Health Affairs...I could have told you that! The
electronic health record gives doctors information about the patient
instantly and helps coordinate care between

500 Years of Women in Art

Beautiful and a reminder of the gift of Women

Spam Comments on EverythingHealth

Dear Readers, I am seeing more and more comments on EverythingHealth
that are not real but are simply there to drive readers to commercial
webpages, advertisers or porn. All bloggers love comments and the
dialog that goes with social media. That is why we blog and I never
delete controversial comments or criticisms. Most commenters are
respectful and very thoughtful and I learn a lot from

Tweet

I've decided, on the sage advice of a WHS reader, to join the world of Twitter.  I'll be using it to announce new posts, as well as communicating papers that I find interesting, but either don't have time to blog about or think are too technical for a general audience.  My tag is "whsource".  Head on over to Twitter if you want to follow my tweets.

Embezzlement in Doctors Offices

I just read an article that talked about more medical practices being
victims of embezzlement. In a 2009 survey of members of the Medical
Group Management Association (MGMA), 83% of 945 respondents said they
had been the victim of employee theft. I guess this means I can come
out of the closet now. I have always been ashamed that my practice of 5
Internal Medicine doctors was embezzeled by