Lap Band - Not the Band-Aid You Want?

Laparoscopic adjustable gastric banding, more commonly known as lap band (which Allergan markets as their trademarked LAP-BAND adjustable gastric banding system), has flourished over the last several years, as evidenced by all the billboards I saw while driving in Southern California last week.

As we attempt to deal w/our nation's obesity, those who are in dire straights w/body mass index (BMI) >40kg/m2 and w/o obesity related health problems and those w/BMI >35kg/m2 w/obesity-related health problems qualify for surgery.  In fact, the FDA just approved decreasing the lower limit to just 30kg/m2 in those w/obesity-related health problems this past month based upon a review of 12-24 month data from a prospective 5 year study.

Ironically, in a study published last month in the Archives of Surgery, the long term outcomes from laparoscopic adjustable banding performed between 1994 & 1997 in Europe where the authors started performing these surgeries in 1992 were not so wonderful during the follow up period approximately 12 years after surgery.  In fact, close to a third of the patients experienced band erosion and close to half required removal of the band.  

Granted the study was small w/only 151 consecutive patients followed, of whom only 82 responded to questions.  Furthermore, tremendous experience has been gained since the beginning close to 2 decades ago with over 300,00 patients enrolled in the BOLD database with over 12,000 patients being added monthly per Allergan.  However, results from this 10 year trial won't be available until 2017 at the earliest.  

In the meantime, I should point out that in Europe (where we often look for advanced medicines & surgical procedures now available years before reaching our shores), there has been a shift away from lap bands since 2004 towards the more traditional gastric bypass.  As noted above, this is quite opposite our national experience where Allergan expects to make $220-240M this year.

And just what are those obesity related health problems?  Cancer, diabetes, high blood pressure, heartburn, heart disease, osteoarthritis (typically hips & knees), sleep apnea, stroke, and more.  This also assumes that the patient has failed all reasonable attempts at medical therapy, eg diet & exercise.  But if you think about, the participants of NBC's Biggest Loser are able to lose just as much weight as those who have surgery.  All they (we) have to do is change our lifestyle.  Something easier said than done for most of us.

You Can't Win A Fight With Your Wife - Part 2

As I mentioned yesterday, some people are going to believe what they want to believe, no matter the proof.  Just like the fact that I'll never win an argument or battle w/my wife.  But having said that, I must now turn the other cheek, at least with regards to vitamin D.  Little did I realize while working in a vitamin D research lab as a pre-med student many moons ago that I would find vitamin D so fascinating and important (sorry! the truth comes out) almost 3 decades later.  While I am not an expert, I am quite the proponent of getting enough vitamin D and checking/reaching optimal levels.

So I was quite disappointed in the Institute of Medicine's recommendations released last November.  In an editorial published in the New England Journal of Medicine last week, it turns out that for non-bone related indications, members of the IOM considered the existing evidence as inconsistent & inconclusive.  Remember that all the current evidence linking vitamin D levels to cancer, cognitive function, heart disease, and infections is observational in nature.  This data is only able to demonstrate an association.

On the other hand, the data linking vitamin D to falls & osteoporotic fractures is consistent & defnitive, having been derived from cause & effect studies, typically randomized, double-blind, placebo-controlled studies.  Which is why the authors agreed upon 20ng/mL as adequate for bone health looking at PTH response.  But when 20-30ng/mL is considered insufficient by Quest Diagnostics, 30-100ng/mL is considered the normal reference range by Quest, and toxicity is manifest only at levels significantly above 100ng/mL, I can't rationally explain why I want to push vitamin D levels closer to 100ng/mL and farther from 30ng/mL (but, of course, without exceeding 100ng/mL) except to think of a grading system.  So yes, I'm one of those who speak with a forked tongue.

But I can think that I can make a reasonable justification in that some vitamin D is necessary for bone health as long as I don't push beyond the upper limit of normal.  On the other hand, when it comes to vaccinations, I find it impossible to come up with a reasonable justification not to get vaccinated (unless one is allergic), especially since those who go unvaccinated expose not only themselves but others to risk of some infectious disease.

Maybe a better analogy is to consider hormone therapy for menopausal women.  Current randomized, double-blind, placebo-controlled evidence warrants giving estrogen + progesterone for symptomatic vasomotor instability at the lowest dose for the shortest period of time, but not for prevention of heart disease or cognitive decline, while observational & laboratory data suggest other potential indications.

I guess what I'm trying to say is that if you want to do something based upon observational data, try to have some cause & effect data supporting your decision, too.

You Can't Win A Fight With Your Wife

My wife & I have been married for over 17 years now and over the years, I've learned that I have a better chance of winning the MegaMillions lottery than I have of winning an argument with her.  I tell my residents & fellows the same thing when it comes to dealing w/(demented) patients who are hallucinating or delusional.  You can never convince these patients that their perception isn't reality.

It turns out there are folks who feel so strongly about something that no amount of science will convince them otherwise.  Granted, we haven't always done a good job explaining the difference between the various types of scientific studies that appear to toss the truth around back and forth.  Some days, coffee is good for you; other days, it's not.  I don't blame them.  But on the other hand, all the existing data tells us that vaccines don't cause autism.  But try to convince the parents of a child who was diagnosed w/autism spectrum disorder soon after his/her vaccination, thanks in no small part to Dr. Andrew Wakefield, who has since been discredited by Britain's General Medical Council and whose fraud has been exposed in a 3 part series authored by Brian Deer as published in the British Medical Journal (part 1, 2 & 3).

So it was with great interest that I read the comments posted at www.USAToday.com regarding a study just published in the New England Journal of Medicine that concludes that fish consumption does not affect mercury levels nor does said mercury levels affect heart disease, stroke & mortality risk.  As of the time that I write this post, none of the 23 individuals who posted a comment believed in the conclusion, most pointing to hidden collusion from an obvious agenda - convincing patients to eat more fish.

Well, let me toss in my 2 cents and let's ignore this study, even though "mercury is a toxin", as one individual posted, and others are (rightly) more concerned about its neurotoxic effects.  Most, if not all, studies looking at the relationship between fish consumption and heart disease (without considering mercury) conclude that more (fish) is better.  Likewise, with most, if not all, studies regarding cognitive function & dementing illnesses - more fish means less (cognitive decline).  In none of these studies has there been any demonstration of harm (besides the occasional fishbone, I suppose).  So I look at this study as superfluous but supportive.  But then again, I eat fish (even had sushi last night).  I doubt that I'll ever be able to convince my colleague to do so.

Magic Pill Prevents Diabetes! Part 2

As a follow up to last Thursday's rant about magic pill(s) to prevent diabetes, I wanted to delve further into exploring the risks associated with pioglitazone, especially since it's pharmaceutical competitor, rosiglitazone, has been linked to increase risk of adverse cardiac events (both are known to increase one's risk for heart failure exacerbations plus both are linked to greater fracture risk) and an earlier version, troglitazone, was pulled off the market due to risk of liver issues.

Now, medically speaking, I tend to lump things together, rather than split them apart.  Of course, the pharmaceutical companies don't like this as they want their product to stand out as superior to the rest.  But given a number of otherwise similar products, I tend to choose the least expensive, generic version that gives me equivalent results.

But let's think about this the other way around.  Let's say that there are 2 drugs, neither one of which is risk-free, sharing some side effects in common (weight gain, edema, heart failure, and fracture risk), but one of which has a significantly greater risk of say bad cardiac outcomes.  While it has not been been demonstrated via randomized, double blind, placebo controlled studies, let's say for arguments sake that all the observational data point toward a significant difference in terms of these cardiac outcomes.  Given this summary, wouldn't you split, rather than lump, and choose the drug with the lower risk profile?

As if you couldn't tell, I was referring to pioglitazone & rosiglitazone.  And in a quirk of fate or perhaps just serendipity, a systematic review & meta-analysis of 16 observational studies involving over 810,000 uses of TZDs (both pioglitazone & rosiglitazone) was just published in the British Medical Journal concluding that the latter drug was associated with a statistically significant greater risk for heart attacks, heart failure & mortality, compared to those who received the former.

So if you're looking for a magic pill w/o side effects that will prevent diabetes, keep looking.  It doesn't exist yet. But if lifestyle modification isn't in the books for you, last Thursday's review offers hope with pioglitazone assuming that you are not risk adverse.  But in one of those rare situations, I wouldn't substitute its competitor, rosiglitazone, even if it were offered to me for free.

Q&A Session at Wellsphere.com

my husband has bleeding from his penis

Q&A Session at Wellsphere.com

Tender (left) abdomen pain

Q&A Session at Wellsphere.com

abdominal lower left mid section bulge

Q&A Session at Wellsphere.com

What is the difference between abdominal hernia & abdominal diastisis (in a man)

Q&A Session at Wellsphere.com

Hello, I have severe middle back pain, vomiting with blood, severe headache and weakness

Q&A Session at Wellsphere.com

my brother is vomiting blood, has severe headache on one side of his head, his mouth kept filling up with water; 

Q&A Session at Wellsphere.com

groin pain

Q&A Session at Wellsphere.com

why does my heart pound and make it hard for me to breath?

Q&A Session at Wellsphere.com

Slight pain on my right side just under my rib cage?

Are You 50 Years Old? Get Your Zostavax Shot!

A good deal of family medicine is focused on prevention, which is different from screening.  In an ideal world, we prevent (all) diseases & illnesses before they manifest themselves.  This is primary prevention.  For instance, washing  hands helps prevent spread of the common cold and other communicable diseases.  So does wearing condoms (well, the latter, anyway).

Most of the time when we speak of screening, we're talking about looking for disease at an early stage where we have better chances of effecting a cure (this is secondary prevention).  For instance, when a patient turns 50 years old, assuming no other risk factors, we typically recommend a screening colonoscopy, looking for pre-cancerous polyps.  And at any visit, we ask about tobacco use, hoping to find those who do and convince them to stop before it's too late, eg Alzheimer's disease, cancer, COPD, erectile dysfunction, stroke, etc.

I mention this because the Food & Drug Administration just (yesterday) approved the use of Zostavax vaccine to prevent shingles starting in those 50 years and older.  If Zostavax sounds familiar, it's because it's already approved (since 2006) for use in anyone 60 years and up.  In fact, a recent study demonstrated a 45% relative risk reduction in shingles in those who received the vaccine compared to those who didn't.  Only 152 individuals needed to receive the vaccination in order to prevent a single case of shingles.  And a major reason to prevent shingles is to minimize the risk of complications, eg post-herpetic neuralgia, a debilitating chronic pain state.

Given that most family physicians and internists are overworked, I'd suggest you bring up this topic and request your immunization rather than risk developing shingles while waiting for your doc to find out about this new indication.  And while you're at it, don't forget to ask for your screening colonoscopy!

Magic Pill Prevents Diabetes!

I read about magic, breakthru pills on the Internet everyday.  Marketing ploys tout all natural, 100% organic, dietary supplements, as if natural & organic equal safe.  Think about this.  Would you wipe your ass w/poison oak or poison ivy?  No?  But it's natural!  Would you snort a line of cocaine, inject some heroin or smoke some marijuana just because no antibiotics & fertilizers were used in their production?  Thought not.  Well, most of you, anyway!

Diabetes, especially the common Type 2 version associated w/being overweight & obese, is becoming a real big problem, pun intended.  We've known how to fix this (prevent diabetes) at least since 2002 - stop stuffing our faces & get off our butts.  However, that's easier said than done.  Most of us are still waiting for that magic pill that will cure everything w/o causing any side effects.

Back in 2002, the Diabetes Prevention Program (DPP) concluded in a randomized study over close to 3 years that lifestyle modification reduced one's risk of developing diabetes by 58% while taking the medicine, metformin, reduced one's risk by 31%, compared to doing neither.  Statistically speaking, these two interventions were considered equivalent.  But I suspect that due to a history of concern over the risk of lactic acidosis as well as its known GI side effects, metformin never gained traction, although some physicians do prescribe it in just such a fashion.

As as you know, inertia trumps lifestyle modification hands down.  Over the next 10 years of follow up after conclusion of the randomized portion of DPP, as published in the Lancet, the total risk of developing diabetes was still lower in those who changed their lifestyle.

Well, for those of you waiting for that magic pill, I'm happy to report that a study published today in the New England Journal of Medicine concluded that pioglitazone reduced the risk of becoming diabetic in a randomized, double-blind, placebo-controlled 2.4 year study 602 patients w/impaired glucose tolerance.  Those who received pioglitazone noted statistically significant lower fasting glucose, HgbA1c (running 3 month average of sugar control), diastolic blood pressure (bottom number), and rate of carotid intima-media thickening (less is good), as well as higher HDL cholesterol (the good kind).

Down sides?  You should monitor your liver function while taking this drug.  And those taking pioglitazone were more likely to suffer from weight gain and edema (fluid retention), both well known side effects.  This particular study was too small & too short to shed any light on the recent revelation of increased risk of fractures & heart failure in those taking pioglitazone.

What about taking both?  After all, we've been treating diabetics with this 1-2 punch for years and there's even a combination pill available, Actoplus Met.  So if you're really not inclined to change your lifestyle and just want to pop a pill to prevent diabetes, I suppose you could have your cake and eat it, too.  Just be sure you don't already have kidney disease and heart failure - and as always, talk it over w/your family physician about whether it's worth the risk or not.  But if you want a risk free solution, stop stuffing your face and get off your ass!  By the way, this study was sponsored by the manufacturers of pioglitazone . . .

Q&A Session at Wellsphere.com

yes sir/mame my mother has high blood pressure as well as high sugar and im not sure what she can eat

Q&A Session at Wellsphere.com

Before my penis used to erect in the morning, but since one week it stop, then what is the cause?

Q&A Session at Wellsphere.com

Can a impotent make girl pregnent???

Q&A Session at Wellsphere.com

How can a man can increase his testorone without any medicine...????

Goldilocks & Activity (Physical & Sexual)

Remember Goldilocks?  She wanted everything just right.  Size of her chair, temperature of her porridge, and firmness of her bed.  Something like that, right?  She didn't like extremes, whether too little or too much of anything.  In reading my posts, I'm sure you've gathered that I believe in the Goldilocks theory of medicine, whereby many of the measurable parameters need to be made just so for optimal health & wellbeing, as opposed to settling for just good enough.

I thought about this some more when I read a study just published in JAMA this week about physical & sexual activity.  It turns out that infrequent or episodic activity, whether physical or sexual in nature, could serve as a trigger for a heart attack or even sudden cardiac death (SCD), more than doubling, even quadrupling one's (relative) risk.  However, to put it into proper perspective, that extra hour of activity is estimated to account for just 2-3 additional heart attacks per 10,000 person-years & 1 more SCD per 10,000 person-years.

On the other hand, habituating oneself to regular activity was associated with the expected 30-45% decrease (relative) risk of cardiac events.  I can hear it now.  Gee, honey, the doctor says we have to have sex regularly to prevent me from having a heart attack.