Archive for April, 2012

Spring Cleaning: Your Fridge and Pantry

April 28, 2012

Blog # 56    Andrew Siegel, M.D.

“The food you eat can be either the safest and most powerful

form of medicine, or the slowest form of poison.”

Ann Wigmore (nutritionist/health educator)

“Food is a drug—use it wisely.”

Ray Kybartas (author/personal trainer)

After an unseasonably mild winter in the northeastern United States, lovely spring has arrived.  Trees and shrubs are sporting supple green buds and the aura is one of renewal, rebirth, new horizons and infinite possibilities.

Following winter stagnation, it is time for spring-cleaning, the annual ritual of purging our homes of clutter, the superfluous, and the old-and-broken.  Applying this re-organization and re-engineering to the hodgepodge of junk in the kitchen, refrigerator and pantry is a noble idea in our quest for health and wellness.

In terms of our health, the most important rooms of our homes are our kitchens and workout areas (if we are so fortunate to have an area that we can dedicate to our fitness pursuits).  Unfortunately for many of us, Big Food has commandeered our kitchens, and they are stocked with an abundance of processed foods that are nutrient-poor, calorie-dense, obesity engendering, disease promoting and often addictive because of the sugar, salt and fat concoctions developed by food scientists in the laboratory.  These boxes, cartons, packages, bags, and cans overwhelm our kitchens and it is high time to wrestle control back from the food industry.

The most compelling tools we have to maintain our health are our forks.  Food is essential medicine capable of healing many chronic diseases and as such it is important to have the same respect for what we eat as we do for any medication prescribed by our doctors.  Think of the supermarket as a large pharmacy, an abundant source of medicinal foods made by nature, many of which are capable of nourishing our health and healing our diseases.  Unfortunately, these healthy medicinal foods are hidden in a vast entanglement of hazardous, disease spawning, addictive drugs representing themselves as food.  With a little savvy, it is not difficult to learn how to navigate the supermarket-pharmacy and distinguish the genuine from the fraudulent.  Think of our pantry as a medicine cabinet and our refrigerator as a place to store perishable drugs. It it is important to learn to read food labels as if we were reading the label on a medication we might choose to give our child.  Before we place a food item in our mouths, we need to ask ourselves the question: will this nourish my health or promote illness?  We also must be very careful not to overdose on any foods as an O.D. of any food—healthy or otherwise—is not a smart strategy.

Two of three Americans are now overweight or obese, an epidemic that has surfaced over the last century, exponentially so over the last few decades. For much of humankind’s time on this planet, calories were scarce and physical activity in the acquisition of those calories was unavoidable. In contemporary times, physical activity is scarce and calories unavoidable.  We are genetically hard-wired to eat when food is available to store calories for the lean times of famine, a not uncommon circumstance for much of our existence. We are not programmed to deny ourselves calories when they become accessible and our biological systems have not yet adapted to this relatively recent problem of too many calories, as the problem has only existed over the past century.  When we factor in our genetic drives; the agri-business mass cultivation of corn, soybeans, wheat, feedlot livestock production; the industrial food complex engineering of abundant, cheap, seductive, readily-available calorie-dense, convenience and junk foods that override willpower by stimulating reward centers in the brain; and aggressive food marketing, we have the perfect storm for the obesity epidemic.  Paradoxically, obesity co-exists with malnutrition because of a diet predominantly consisting of nutrient-lacking, high-caloric processed foods.

When desire coexists with opportunity (our eating environment), most humans will take the path of least resistance and consume.  So, when that sweet Babka bread was sitting on the center island of the kitchen this morning, the most primitive elements of my brain recognized its availability and convenience (so much easier than the minor hassle of toasting a piece of whole wheat bread and smearing some organic peanut butter on it), and that became my breakfast, along with a mug of black coffee.  If the Babka wasn’t there, it would not have been my breakfast.

Now is the time to replace the unwholesome food-like junk that litters our homes with real food and start on the journey to a healthier existence.  Dr. Brian Wansink, author of Mindless Eating: Why We Eat More Than We Think, believes that if we want to change our eating habits and behaviors, it is simply easier to change our environment than our minds.  (For more details, see my July 9, 2011 blog, which summarizes his book: https://healthdoc13.wordpress.com/2011/07/)  Although our ultimate goal is to be able to eat smartly and sensibly no matter what food environment we are exposed to, by creating the right food “domain” at home, it will make this goal all the more easier to achieve.

The following are general principles for cleaning out and re-stocking your refrigerator and pantry in a way to ensure healthy and safe eating:

  • In general, the healthiest foods are the freshest and most perishable; they have the shortest shelf lives and they promote humans not perishing prematurely.   Conversely, the unhealthiest foods are the most imperishable; these dubious food-like substances have prolonged shelf lives—think processed foods like Twinkies—and certainly do not prolong human shelf life.  The French do it right by shopping daily for healthy, fresh, perishable vegetables, fruits, breads, cheese, meat and fish.  To access the freshest and most perishable foods, keep your grocery cart on the perimeter of the supermarket while avoiding the interior aisles.
  • Stock up on whole foods, foods with one ingredient, as opposed to foods that consist of a mélange of ingredients mixed together and prepared. These real foods include fresh fruits, vegetables, whole grains, legumes, nuts, seeds, and lean animal protein including fish, chicken and eggs.  Real foods are nutritionally dense and provide fiber, vitamins, minerals, and anti-oxidants.  If we could see the precise ingredients and means that go into making many processed concoctions—particularly packaged foods—we would be much more reluctant to eat them. The final product simply hides all the component ingredients. Real food does not need a label to identify it since its identity is readily apparent.  Of course some whole foods will come in cans, including beans, artichokes, tomatoes and sardines. Likewise, some healthy foods will contain more than a single ingredient and be packaged.  A general rule of thumb to ensure the healthiness of any given product is to look for foods that contain no more than 5 identifiable, known, wholesome ingredients.
  • When it comes to the all-popular nut butters including peanut butter, almond butter, cashew butter, etc., try to stock up on brands that contain just the nut, with no other unhealthy additives.  Many peanut butters, for example, will contain sugar, salt, and partially hydrogenated oils.
  • Focus on food quality as opposed to food quantity.  Ideally, animal products are pasture-raised and free of antibiotics and hormones; plant products are organic, local and seasonal.  With respect to pesticide load, the following fruits and vegetables—the “dirty dozen”—are the worst, so going organic if possible is advisable for these: peaches, apples, sweet peppers, celery, nectarines, strawberries, blueberries, lettuce, grapes, spinach, potatoes and pears.  Animal fat is a haven for pesticides and toxins. The quality of fat of animals that are raised on grass pastures is quite different than that of animals raised on confined feedlots, both with respect to the fatty acid content and the toxicity. Predatory fish and river fish including swordfish, tuna, Chilean sea bass, and halibut often contain mercury and other contaminants and should be consumed in moderation. Salmon, sardines, herring, shrimp, and scallops are considered to have low mercury and other toxins.
  • Stock up on healthy vegetable fat sources (predominantly monounsaturated and polyunsaturated) include avocados, olives, olive oil, and other nut and seed oils including walnut, sesame, sunflower oils.
  • Stock up on a variety of healthy protein sources including beans, legumes, whole soy products, nuts, seeds, eggs, seafood, and lean meats.
  • Stock up on low-glycemic index carbohydrates—those that have a low propensity to rapidly raise blood sugar (vegetables, fruits, whole grains)—as opposed to high-glycemic index carbs (sweets, soda, juices, candy, white bread, white rice).
  • At times, processing is a necessity to make foods accessible to us, so it becomes very important to be able to intelligently read and understand the food label, with the same attention and scrutiny that you would give to a drug label because after all, food is medicine—medicine that can heal or medicine that can promote disease.  Remember: labeled food should have only a few ingredients.  Any more than a few, don’t stock in your pantry.  If you can’t recognize or pronounce the ingredients, don’t stock in your pantry.
  • Don’t stock foods that make health claims.  Real food does not need claims since the food speaks for itself. Big Food uses many misleading descriptors including: “fortified”, “lite”, “multigrain”, “all natural” and “organic”—they sound great for our health, but really are just words without substance.  The term “all-natural” resonates nicely but is meaningless—many things are all natural including syphilis and melanoma.   “Multigrain” conjures up images of a medley of farm-fresh healthy grains, but in reality translates to being made from more than one grain, all of which may be highly processed.  “Organic” is a powerful term that evokes thoughts of food grown without the use of chemical fertilizers, growth hormones, antibiotics, or pesticides.  However, there are many definitions for the word “organic,” and understand that when I walk my English spaniel to do his “business,” he leaves a large, steaming pile of organic material on the ground!
  • Beware of other hanky-panky and deceptive labeling practices: The predominant ingredient is listed first and others in descending order, and it is desirable that the predominant ingredient be a healthy one.  Many processed foods are predominantly sugar.  Big Food’s deception is to use different forms of sugar (molasses, cane juice, honey, maple syrup, agave, etc.) to “unbundle” and thus remove the sugar as the predominant ingredient.  For example, instead of sugar being listed first, they might list brown sugar second and organic cane juice third, removing sugar from the top of the order. Many breakfast cereals are predominantly sugar, but if sugar were listed as the primary ingredient, many consumers would choose to leave the product on the supermarket shelf.  Additionally, there is often a sleight of hand applied to the number or the size of servings delineated on the package, with a realistic-sized serving being much larger and higher in calories than stated.
  • Do not be hoodwinked by items that promote fruit on their labels.  Fruit-flavored yogurt, for example, often contains large amounts of corn-syrup solids; a much better choice is to use plain, vanilla or lemon yogurt and supplement with fresh fruit.  Likewise, the popular “fruit” roll-up kids snack in no way resembles real fruit—it is just a concoction of sugars, dyes, additives, and unpronounceable, unknown ingredients.
  • Don’t stock high-glycemic beverages that are naked liquid calories including sodas, sweetened iced tea and lemonade, fruit juices, and sports beverages.  Do stock water, seltzer, non-fat or low-fat dairy or non-dairy alternatives including soy and almond milk.
  • Don’t stock foods containing metabolic poisons including high fructose corn syrup, partially hydrogenated vegetable oils, and enriched wheat flour.
  • Don’t stock foods laced with preservatives, additives, coloring, dyes or those that contain artificial sweeteners.
  • Beware of the sodium content of the food that you stock up on; even the seemingly healthiest of foods can be loaded with salt, with one serving far exceeding the recommended daily allowance.


Bottom line:  Resonate with nature and literally think “outside the box,” can, package, bottle, etc., by stocking your pantry and fridge with whole, natural foods and not their refined by-products. Whole and real foods do not require a label because what you see is what you get. Leave the chemistry experiments to the food science lab and not for our consumption. Processing is a necessity to make some foods accessible to us, so read food and nutritional labels as carefully as you would read the ingredients in a medication, because when it comes down to it, food is medicine. The best diet is the “anti-processed-atarian” diet.  Re-engineer your food environment by discarding the unnatural-chemical-junk-slop and stocking up on the wholesome, natural and healthy foods that are capable of nurturing and healing. Your body will thank you.

Andrew Siegel, M.D.

Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food

www.PromiscuousEating.com

Now available on Amazon Kindle

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Diabetes and the Urologist

April 21, 2012

Andrew Siegel, M.D.   Blog #55

“Let food be your medicine and medicine be your food.”

Hippocrates

Many diseases and disabilities are related to the quantity and quality of the foods we eat and the amount of exercise we get or don’t get.  The most prevalent form of diabetes, Type 2, is a classic example of an avoidable disease that occurs because of lifestyle indiscretions. Type 2 diabetes is now occurring in epidemic proportions and, sadly, can have catastrophic consequences including: heart disease, strokes, blindness, kidney failure requiring dialysis and vascular disease resulting in amputations.  This disease has the capability of dramatically decreasing the quantity and quality of our lives.

There are over 25 million diabetics in the USA, and the incidence is rapidly spiraling upwards, particularly because of poor dietary choices and insufficient exercise.  Diabetes causes elevated blood glucose (i.e., sugar) and occurs on the basis of a defect in the body’s ability to produce the pancreatic hormone insulin or use the insulin (insulin resistance). The function of insulin is to regulate glucose and move it  into our cells so that it can be used for energy and metabolism.  When insulin is unavailable or the body has developed resistance to its effect, blood glucose levels rise uncontrollably with potential dire health complications.

Common presenting symptoms of diabetes are frequent urination, thirst, extreme hunger, weight loss, fatigue and irritability, recurrent infections, blurry vision, cuts that are slow to heal, and tingling or numbness in the hands or feet.  However, the most common symptom may unfortunately be…no symptom at all.

There are two distinct types of diabetes.  These were formally called juvenile diabetes and adult-onset diabetes, but because of the increasing incidence of obesity in children (such that children are now developing adult-onset diabetes), they have been renamed Type 1 and Type 2.  Type 1diabetes is not linked to obesity and is responsible for about 5% of diabetes.   It is an autoimmune condition in which the body’s immune system destroys its own insulin-producing cells, thus severely limiting or completely terminating all insulin production, and is often inherited. It is managed by insulin injections or an insulin pump. 95% of diabetes in the USA is Type 2 diabetes, also known as diabesity (diabetes caused by obesity). This form of diabetes is typically on the basis of insulin resistance, due predominantly to environmental factors including overeating and sedentary living.  Unlike Type 1, Type 2 diabetics produce plenty of insulin, but their bodies cannot process the insulin and are resistant to its actions. Anybody who has excessive abdominal fat is on the pathway from insulin resistance towards diabetes.

While Type 1 diabetes is treated primarily with insulin replacement, diet and exercise are also necessary for its management. With Type 2 diabetes, it is imperative to pursue a lifestyle modification, including dietary changes that avoid certain diabetic-promoting foods and replacement with healthier foods.  Diabetics should refrain from high glycemic index foods (those that are rapidly absorbed) including sugars and refined white carbohydrates and instead should consume high-fiber vegetables, fresh fruits, and whole-grain products.   Regular exercise is equally as important as good dietary habits, and the combination of healthy eating, physical activity, and weight loss can often adequately address Type 2 diabetes.  When lifestyle measures cannot be successfully implemented, there are different classes of medication that can be used to manage the diabetes, although lifestyle modification should always be the initial approach, since lifestyle (in large part) caused the problem and is capable of improving/reversing it.   At times, when diet, exercise and drugs have not been able to control the diabetes, bariatric (weight loss) surgery might be needed to control and even potentially eliminate the diabetes.

As a urologist (a urinary tract specialist), it is not uncommon for me to make the initial diagnosis of diabetes.  This is because diabetes often presents with urinary frequency, a symptom typically treated by urologists.  Sleep-disruptive nighttime frequency is a particularly disturbing symptom and is often a major complaint that brings patients into my office.  Because diabetes causes high levels of blood glucose, this results in glucose in the urine, which causes a diuretic effect (lots of urine production).  In fact, earlier this week a patient came in complaining of new onset of significant urinary frequency; his urinalysis on dipstick showed glucose (normally there should be no glucose in the urine) and his serum glucose was over 400 (normally < 100).  He was promptly sent to his internist for management of Type 2 diabetes.

Additionally, many uncircumcised men who present to my office with foreskin problems have diabetes.  In fact, when a man has foreskin issues such as the foreskin being stuck down over the head of the penis and is not able to be pulled back (phimosis), the first thing I do is to dipstick the urine for glucose.

Aside from urologists having the occasion to make the initial diagnosis of diabetes, we also have ample opportunity to treat many diabetic patients because of the urological problems that can occur as a result of the diabetes, including urinary infections, bladder conditions, and sexual problems such as erectile dysfunction. Additionally, recent studies have indicated that diabetes greatly increases the risk of kidney stones. Although many of these symptoms are common with the aging process in the absence of diabetes, the presence of diabetes hastens them, causing earlier onset and increased severity of these issues.

In general terms, the complications of diabetes occur because of damage to blood vessels and nerves.  Diabetes accelerates atherosclerosis, a condition in which fatty plaques get deposited within the walls of arteries, compromising blood flow and the vital delivery of oxygen and nutrients to tissues. Diabetic “small blood vessel” disease can lead to retinopathy (visual problems leading to blindness), nephropathy (kidney damage leading to dialysis), and neuropathy (nerve damage causing loss of sensation in the hands and feet). Diabetic “large vessel disease” can cause coronary artery disease, stroke, and peripheral vascular disease.  Diabetes increases the risk of infections because of poor blood flow and impaired function of the infection-fighting white blood cells.  It is important to know that diabetic control can lower the chances of the early onset and severity of the aforementioned problems.

Many diabetics have urological problems on the basis of neuropathy that affects the bladder.  These issues include impaired sensation in which the bladder becomes “numb” and the patient gets no signal to urinate and impaired bladder contractility in which the bladder muscle does not function properly, causing inability to empty the bladder completely.  Other diabetics develop involuntary bladder contractions (overactive bladder), causing such symptoms as urgency, frequency and incontinence.  The good news here is that there are effective, non-invasive means of managing diabetic voiding dysfunction.

Diabetics have many more urinary tract infections than the general population because of many factors including improper functioning of the infection-fighting white blood cells, glucose in the urine (a delightful treat for bacteria) and compromised blood flow to the kidneys and bladder.  Diabetics have a greater risk of asymptomatic bacteruria and pyuria (the presence of white cells and bacteria in the urine without a frank infection), cystitis (bladder infections), and pyelonephritis (kidney infections).  Impaired bladder emptying further complicates the potential for infections.  Diabetics have more serious complications of pyelonephritis including kidney abscess, emphysematous pyelonephritis (infection with gas-forming bacteria), and urosepsis (a very serious systemic infection originating in the urinary tract requiring hospitalization and intravenous antibiotics).  Fournier’s gangrene (necrotizing fasciitis) is a soft tissue infection of the male genitals that often requires emergency surgery (that can be very disfiguring) and has a very high mortality rate.  Over 90% of patients with Fournier’s gangrene are diabetic.  Diabetic patients also have an increased prevalence of infections with surgical procedures, particularly those involving prosthetic implants, such as penile implants, artificial urinary sphincters, and mesh implants for pelvic organ prolapse.

Satisfactory sexual functioning is predicated upon good blood flow and an intact nerve supply to the genitals and pelvis.  Diabetics often develop sexual problems because of the combination of neuropathy and blood vessel disease.  Men commonly have a reduced sex drive and have difficulty achieving and maintaining erections.  Diabetes has clearly been linked with testosterone deficiency that can worsen libido and sexual function.  Because of the neuropathy, many diabetic males have retrograde ejaculation, a situation in which semen goes backwards into the bladder and not out the urethra.  Female diabetics are not spared from sexual problems either and commonly have reduced desire, decreased arousal, and vaginal lubrication issues.

In summary, diabetes is a serious chronic illness with potentially devastating complications. Type 1 diabetes is relatively rare and unavoidable, but is eminently manageable with insulin replacement. Type 2 diabetes is now epidemic and its prevalence has increased dramatically coincident with the expanding American waistline. Type 2 is avoidable and can be improved/reversed through integration of healthy eating habits, weight management, and exercise.

Many people—myself included—do not relish seeing doctors, because such visits can be frightening, invasive, and sometimes uncomfortable.  It is a simple fact that healthy people do not need to consult doctors very often, aside from routine “wellness” visits.  The corollary is if you don’t want to see doctors very often, stay healthy.  To stay healthy you need the right lifestyle—avoiding tobacco, maintaining a satisfactory weight, eating healthy foods and drinking in moderation, avoiding stress, and getting plenty of exercise as well as adequate sleep. If your lifestyle is not up to par, remember that it is never too late to change. Your health is ultimately your own responsibility, but as doctors, it is our responsibility to help educate you and guide you towards the pathway of healthy habits and lifestyle—there is simply no magic bullet other than this.  Lifestyle modifications can be amazingly restorative to your health and overall well being.  And simply put, there is absolutely nothing else that transcends being healthy.

A special thank you to diabetes specialist Joseph Giangola, M.D. for reviewing and editing this blog entry.

Andrew Siegel, M.D.

Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food

www.PromiscuousEating.com

Now available on Amazon Kindle

The Medical Device Industry: A Cautionary Tale

April 14, 2012

Blog #54    Andrew Siegel, M.D.

 

Medical devices are capable of saving lives and vastly improving the quality of our existences.  Prosthetic valves for cardiac valve problems, artificial joints for severe arthritis, defibrillators for heart rhythm issues, urethral slings for stress incontinence, penile implants for erectile dysfunction, etc., can make a meaningful contribution to our health and well being.  There are countless novel technologies that have been able to achieve unparalleled benefits for society.  Sadly, despite enormous upside potential for improving our longevity and lives, medical devices can also maim, or on rare occasions, even kill us.

One of the greatest strengths of the USA is the wonderful culture of innovation that we thrive in, as well as a system of colleges and universities that is bested by no other country.  As important as innovation is to ensure that we have access to lifesaving and lifestyle-improving devices, so is a system that is capable of guaranteeing safety and effectiveness.  As devices have become more complicated, the current device-approval system has failed the task of assuring us that all implanted devices are safe and effective.  The device-approval system currently in place is obsolete, having been designed in 1976, at a time when devices were fewer and far less complex.

The United States device regulatory process was initiated in 1938.  In 1976, Congress passed the Medical Device Amendments, which established the foundation of the present system.  Devices are triaged into three classes of risk:

Class I devices (low risk): e.g., tongue depressors

Class II devices (moderate risk): e.g., hard contact lenses

Class III devices (high risk): e.g., heart valves

There are two means of getting a new medical device on the market. The more stringent method is the PMA process (Pre Market Approval).  This is mandated by the Food and Drug Administration (FDA) for class III devices and involves extensive clinical testing. A less stringent FDA process to gain clearance (note the use of the word clearance as opposed to approval) for a new medical device without the need for human testing is known as 510(k) clearance process, named for the statute from which it is derived The 510(k) criterion of clearance of a new medical device is that it is “substantially equivalent to a predicate device”—in other words, that it is very similar to a device that is already on the market.  No clinical data or clinical trials regarding safety and effectiveness are required with a 510(k) clearance.  Every year, several thousand medical devices are cleared via the 510(K) process, representing approximately one third of all new devices.

The PMA standard for approval of class III devices is safety and effectiveness, while the standard for 510(k) clearance is substantial equivalence to a previously cleared “predicate” device.  Unfortunately, the assumption that a device that is “equivalent” to a previous similar device will be as safe and effective as that device is often erroneous.  Although the FDA may request preclinical or clinical data to support the claim of equivalence, a finding of equivalence is by no means a determination that a device is safe and effective.

An effective device approval system should be capable of balancing innovation and safety.  The process should be sensible and efficient such that patients have expedient access to innovative medical devices.  On the one hand, regulation should not be a burdensome process that stifles innovation and compels device manufacturers to go overseas. On the other hand, the regulation serves an important role in oversight, safeguarding us from risky and untested medical devices.

Mentor Obtape: My Involvement      

Sub-urethral slings are small strips of material that are used to treat stress urinary incontinence (urinary leakage with exercise, sneezing, coughing, etc.) in women.  They work by providing anatomical support to the urethra (the urinary channel leading from the bladder to the external opening).  They are placed by a simple outpatient procedure and can dramatically improve the quality of life of women who suffer leakage with physical activities and exertion.

A few years back, I found myself enmeshed in a public health nightmare regarding a particular type of sling made by the Mentor Corporation called the ObTape, an abbreviation for obturator tape. This sling was cleared by the 510(k) process and had multiple predicates.  In other words, this device was cleared because it was found to be substantially equivalent to an existing device that had previously been cleared, in turn, by being found substantially equivalent to another device!

In 1999, Mentor’s Porges division introduced the Obtape sling to the European market.  What was unique was the means of sling placement—via the obturator area of the groin, as opposed to the original technique that placed the sling via the lower abdomen—avoiding the potential perils and hazards of abdominal procedures.  Interestingly, the original European product was called Uratape, a synthetic material made of polypropylene with a central silicone coating.  Because of a high incidence of vaginal extrusion associated with the Uratape, it was withdrawn from the market and replaced with the Obtape that had no silicone component.   (Vaginal extrusion is a condition in which the sling does not incorporate properly into the body and is exposed and visible in the vagina.)

Beginning in 2003, over a 15-month period I implanted ObTape slings in 30 patients with stress incontinence.  In follow-up, it was noted that many patients were having problems with sling integration, with the vaginal wall failing to heal properly and the sling extruded or exposed.  When I came to realize that this adverse event was more than just an isolated occurrence, I stopped implanting the ObTape sling.   Ultimately, six patients (20%) were found to have vaginal extrusion requiring removal of the sling material.  This complication, in which the sling fails to integrate properly into the body, causes bloody vaginal discharge, pain, infections and the presence of exposed sling in the vagina.

I voiced my concerns to Mentor Corporation on several occasions regarding the integration problems that my patients were experiencing.  Mentor’s representatives had the audacity to suggest that the problem was “on a technical basis secondary to inadequate vaginal closure technique.” I was advised to close the vagina in two layers as opposed to the typical one layer that is the standard.  In other words, Mentor was blaming the problem on the physician (that being me), rather than the device.  I rejected the Mentor response because of my significant experience with trans-vaginal sling procedures since completing a fellowship in incontinence and female urology in 1988, having always closed the vagina satisfactorily in one layer.

It was my judgment that the Mentor ObTape sling incurred an unacceptably high rate of defective vaginal wound healing and extrusion and should be considered inappropriate for use in sling surgery.  I wrote up my findings based upon my thirty patients and in November 2005, an article entitled:Vaginal Mesh Extrusion Associated With Use of the Mentor Trans-Obturator Sling” appeared in our Urology journal (The Gold Journal).  My conclusions were that the sling material was the source of the problem: in short, the ObTape has micro-pores and is inelastic.  Pore size is a critically important factor in sling surgery, allowing for tissue in-growth and hence integration.  ObTape has small pores—approximately 50 microns in diameter—that are more apt to harbor bacteria and impair tissue in-growth and integration than larger-pored slings.  Additionally, the inelasticnature of the sling impedes the ability of the sling to adhere to the contours of the urethra and underlying tissues; this predisposes the sling to lay immediately above the vaginal wall (versus lying directly under the urethra), another set up for poor integration and the potential for extrusion.  The alternative slings at that time—those made by Gynecare, American Medical Systems and Boston Scientific—were more elastic and had macro-pores greater than 80 microns and did not have incorporation problems.

Subsequent to my publication, numerous other clinicians reported similar problems with vaginal extrusion and poor integration of the Mentor sling.  Mentor eventually voluntarily withdrew the Obtape from the market, replacing it with an alternative macro-pored sling.  The large number of complications resulting from the use of the Obtape sling engendered numerous lawsuits.  Because my Urology article was the first to report the complication, I received calls from many attorneys across the nation requesting that I serve as a medical expert in numerous patients’ claims against Mentor Corporation.  I was more than happy to participate in this capacity, because I knew firsthand the personal havoc wreaked by Mentor’s defective product.  Ultimately, there was a major settlement between Mentor Corporation and the attorneys representing hundreds of injured women who had had the ObTape implanted.

The bottom line was that this sling was brought to market prematurely, before adequate human testing.  As it ended up, the sling testing experience was done on the collective private patients of urologists and gynecologists throughout the nation.  Furthermore, Mentor had European data that documented integration issues that was withheld from implanting surgeons when the sling became available in the USA.  What the enthusiastic Mentor representatives did present to us was supporting data including 4 disks—one of an anatomical dissection, two disks showing surgical technique and one containing a PowerPoint presentation. On the surgical technique disk, a nationally renowned leader from a prominent American medical school fully endorsed the ObTape, stating that the ObTape “retains its advantage against the gold-standard TVT (Tension-free Vaginal Tape).”  The narrator of one of the surgical technique disks stated that the ObTape monofilament polypropylene tape gives “excellent properties of incorporation and colonization.”

With entrepreneurial haste and aggressive salesmanship, this defective sling was foisted upon surgeons with misleading and incorrect supportive materials and data. Essentially, Mentor Corporation marketed an ill-designed product that did not have the properties necessary to achieve maximal biocompatibility, resulting in numerous patients with integration and incorporation issues.  Pre-market testing received short shrift, and in Mentor’s zeal to release the first trans-obturator sling in the nation, many damaged patients were left in its wake.  Data, published by myself and corroborated by MAUDE (Manufacturer and User Facility Device Experience) and numerous other physicians, unequivocally showed extrusion and incorporation issues.  I, among many other surgeons, was mislead by Mentor Corporation, strongly persuaded by the Mentor sales force that the ObTape sling was not only effective and less invasive than alternative slings, but that it passed muster in terms of safety.

The ObTape was FDA cleared based upon it being a Class II device, and thus upon the 510(k) process of  “substantial equivalence” to a predicate product.  The predicate of the ObTape was the Johnson and Johnson Gynecare TVT sling.  Mentor Corporation’s claim was as follows: “Mentor ObTape is substantially equivalent in material, performance, production, and design to the urethral support tapes for the manufacture produced and marketed by Johnson and Johnson.”   This claim was flagrantly incorrect!  Interestingly, the predicate device for the Johnson and Johnson Gynecare TVT was a Boston Scientific sling, the ProteGen sling.  The ProteGen sling was made of polyester fabric coated with collagen. The ProteGen sling was a total disaster, incurring major integration issues and ultimately being withdrawn from the market in January 1999.  So the child that failed—the Obtape sling—had as its parent a great sling—the TVT, but as its grandparent, a disaster sling—the ProteGen.  The ProteGen was cleared in 1997 based on a substantial equivalence, since the polyester fabric coated with collagen was already in use for cardiovascular grafting.

What was the FDA thinking?  Do we not entrust the FDA to safeguard us from devices that are unsafe?  Shouldn’t the FDA approach devices with the same regulatory scrutiny accorded to drugs?  If the ObTape sling had been classified as a class III device instead of a class II device, it would have demanded a much more stringent regulatory process prior to approval.  In my opinion, despite shortcomings in the ability of the Food and Drug Administration to police drugs and devices, the ultimate responsibility for assurance of device safety and satisfactory pre-market testing falls upon the manufacturer.

The 510(k) device-approval system is clearly antiquated and needs to be replaced with a new system that will assure safe and effective devices and avoid the potential for tragic innovations like the ObTape.  The predicate system is flawed and the shortcomings of the multiple predicate approach are even more profound.  Physicians as well as the public want assurance that a device is safe and effective, not that it is “equivalent” to another device, and that its benefits outweigh its risks, assurances that the 510(k) cannot provide.

We need a system that adequately tests devices before they come to market, so that we have the surest guarantee possible that the new devices are beneficial and do no harm.  Equally as important is a system that provides oversight after any new device is made available.  Registries must be created to monitor and track every patient who undergoes a device implantation—this would provide a means of collecting data, analyzing it, and acting upon it.  In this way, if a device comes to market with seemingly satisfactory safety/efficacy pre-market data that turns out to be erroneous with follow-up registry data revealing unanticipated complications, there would be a system in place to manage this.  This system would benefit from a means of rapidly disseminating this information to the medical community as well as the public and furthermore demands a process by which flawed devices could be expediently recalled and banned from future use.  In this way, physicians and patients could be best assured that available devices are sound and safe.

Link to N.Y. Times article on Mentor ObTape in which I am interviewed:

http://www.nytimes.com/2009/05/05/health/05tape.html?pagewanted=all

Andrew Siegel, M.D.

Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food

www.PromiscuousEating.com

Now available on Amazon Kindle

“Igniting” Your Metabolism

April 6, 2012

 


Blog #53   Andrew Siegel, M.D.

Our metabolism is defined as the sum of biochemical reactions that occur within our cells in order to sustain our lives.  Our metabolic processes include anabolism (the constructive process in which simple compounds are converted into complex substances, for example, the building of muscle and bone) and catabolism (the destructive process by which complex substances are converted into simpler compounds, with release of energy).  Our metabolism balances anabolism and catabolism to keep our weight as stable as possible, despite varying caloric intake and energy expenditure.

Why would we want to “fire up” our metabolism?  By revving it up, it will help us achieve “fighting” weight and reveal our sinewy body, so we will ultimately look and feel better. Another even more compelling reason is to achieve optimal health—when we attain fitness by way of healthy eating, weight reduction, regular exercise and avoidance of tobacco, we reduce our risk for diabetes by 90%, heart disease by 80%, and cancers by 50-60%. Another motivation is to add quality and quantity to our life.  Finally, stoking our metabolism will help us gain energy.

Our muscles are key players in our metabolism, as they are quite metabolically active—each pound of lean muscle burning 50 or so calories/day.  It is easy to understanding why muscles are such large consumers of energy (calories) if you think of the service that muscle cells provide as compared to skin cells, fat cells, liver or kidney cells, etc.  Some of the many roles that muscles play include skeletal muscle contraction for activities required in our daily existence such as movement, chewing, talking, etc.; cardiac and diaphragm muscle contraction that proceeds without interruption, often for eighty or more years; and smooth muscle contraction in our blood vessels, intestines and urinary tract.

With a sedentary existence and aging, there is a gradual loss of muscle mass and a resultant slowing in our resting metabolism.  By building and maintaining our muscle mass with strength training, our resting metabolic rate will be higher and we will burn more calories. Exercise is also our endogenous stress reducer, lowering cortisol levels, suppressing our appetites and helping us burn carbohydrates before they have a chance to be stored as fats. Additionally, exercise serves to increase the “insulin sensitivity” of muscle, which means that our muscles become more efficient at utilizing carbohydrates as fuel.

On a practical basis, the term “metabolic” is often used to refer specifically to the breakdown of food and its transformation into energy.  Metabolic reactions and processes take place in our cells to convert biochemical energy from dietary nutrients into ATP (Adenosine TriPhosphate), the metabolic currency of our cells. The energy stored in ATP can be used to drive any process requiring energy.  Every cell in our body requires energy to function and energy demands are greater when cellular work is increased.  Just as our cars will expend more fuel when we travel at 60 mph as opposed to 25 mph, so our cells will need to use more energy when increased demand is placed upon them, for example, muscle cells during physical exertion as opposed to resting.

ATP provides the energy for any and every cell, whether that cell is a brain cell, an intestinal cell or a muscle cell. ATP is a molecule of adenosine bound to three phosphates.  It requires extra energy to bind the second to the third phosphate and this provides the power source of the cell.  When energy is needed, the ATP is broken down into ADP (Adenosine DiPhosphate), releasing the third phosphate and a burst of energy.  So ATP can be thought of as a fully charged battery and ADP as the spent battery.  When the battery is recharged, the phosphate is reattached to ADP to make ATP.  This can only occur in the presence of oxygen (oxidative metabolism). Our dietary calories provide the energy needed in order to reattach the phosphate to ADP, that is, to recharge the battery.

We do not keep a ready store of ATP available, but are capable of manufacturing it on demand. Our cells in amounts appropriate to their specific needs can then use the energy in ATP.  This oxidation of nutrients occurs via a complex series of chemical reactions within the mitochondria of our cells. These chemical reactions are dependent upon oxygen use and they speed up as demand increases.  The ultimate result of oxidative metabolism is the production of ATP.  This is absolutely clean combustion, with the waste products being only water and carbon dioxide.  Similarly to how our cars use a mixture of fuel and oxygen that is ignited for combustion to drive the pistons, so our bodies need oxygen and fuel (nutrients).

Unlike our vehicles, we are capable of providing energy to our cells even when oxygen demand exceeds supply.  When oxygen becomes scarce—that is, when oxygen demand exceeds supply because of the intensity of exercise, non-oxidative metabolism kicks in.  This encompasses the breakdown of glucose or glycogen.   Glucose, circulating in our blood, or glycogen, stored in our liver and muscles, is converted to lactic acid under such anaerobic conditions.  This takes place in the cytosol (fluid within the cell), as opposed to oxidative metabolism, which takes place within the mitochondria.

Our energy source is flexible, as we are capable of using any nutrients— carbohydrates, fats, or proteins—whether they come from a recently ingested meal, or are stored in our liver and muscles (glucose storage in the form of glycogen), or are derived from fat reserves.  Obviously, it is desirable to use our fat and carbohydrate stores for energy and not our protein (muscle and internal organs).  Protein catabolism for energy usually happens only with starvation, when carb and fat stores are depleted; under these circumstances we lose lean body mass to provide the energy for survival.

At the lowest exercise intensities, the energy from the consumption of fats is our main energy source.  At intermediate energy intensities, the energy derived from carbohydrates and fats is roughly balanced. When oxygen delivery is compromised by a further increase in exercise intensity, the anaerobic system kicks in, which uses primarily carbohydrates as its energy source. There is a good reason that glycogen is stored in our muscle cells— the source of energy for our muscles is conveniently located in the very cells where it is needed and can be rapidly accessed when the demands on muscle are intensified. So, for example, sleeping will use fats as a primary energy source.  On the other hand, sprinting will use carbohydrates.  Activities at intensities between these two extremes will use a graded mixture of these two fuel sources.

When talking metabolism, it is helpful to think of our glycogen as our “small fuel tank.”  Once the fuel in the liver and muscles is exhausted, our “large fuel tank”—our fat—needs to be tapped to provide energy.  In contrast to the limited carbohydrate storage in our liver and muscles, our bodies abundantly store fat.  Depending on how much fat we have, many days to weeks of energy can be provided.

Lou Schuler, a fitness journalist and author of many popular books about strength training and nutrition, wrote a nice article entitled “Reprogram Your Metabolism” in March 2012 Men’s Health. I have borrowed several of his concepts and highly recommend going to the source and reading the entire article.

As stated earlier, our metabolism balances anabolism and catabolism and is able to strike a metabolic balance to keep our weight stable. Interestingly, if we eat excessive calories, our bodies compensate by speeding metabolism and conversely, if we consume too few calories, our bodies compensates by slowing metabolism.

Essentially, we are hard-wired to adapt to famines and starvation by metabolic slowing and holding on to fuel (fat) and to adapt to times of feasting and plenty by metabolic speeding and fuel burning. The process of eating, in and of itself, notches up the metabolism as the body gets “exercise” in the digestive process, particularly if a high fiber load is eaten.

Metabolic flexibility allows us to easily shift gears between the two nutrient fuels—carbohydrates and fats—that we use for energy purposes. Metabolic inflexibility is a situation in which the body loses the ability to selectively burn carbohydrates or fats in accordance with the demands of the situation. Schuler believes that a big part of the rampant obesity problem is metabolic inflexibility.  Food scientists working for the industrial food complex have mastered combining sugar, salt and fat into highly available, highly palatable, highly stimulating, highly rewarding, highly caloric, highly addictive concoctions that have sabotaged our metabolic systems.   After such a massive glucose load, insulin is released so that the energy can be used and stored. When insulin levels become chronically elevated, we start accumulating fat; when levels are low, we burn fat for fuel.  Insulin is all about increasing fat storage and decreasing fat burning—this is why diabetics on insulin injections typically get fat.

Under circumstances of chronic consumption of processed junk foods it thus becomes very difficult to tap our fat stores because of the chronic insulin elevation. This fosters a metabolic disaster, thwarting our metabolic flexibility and resulting in burning carbohydrates as fuel and leaving fat stores intact.  The resultant low carbohydrate levels lead to hunger, and since the metabolically inflexible have chronic low carbohydrate stores, they are always hungry.  So here we have a very dangerous situation—a fat abdomen, high levels of insulin, low carbohydrate stores, and hunger.  This paradox—hunger in the face of obesity—can only be resolved by lowering insulin levels so that the fuel stored as fat can be tapped as an energy source.  The only way to achieve this is to lower carbohydrate intake and ramp up physical activities.  As a consequence of intake of fewer carb calories and better quality carbs (whole grain, fruits, vegetables, legumes, etc.), insulin levels will decrease, fat will melt away, hunger will dissipate and we will lose weight, gain energy, feel and look better and avoid many preventable diseases.

Pearls to “jump start” your metabolism:

  • Resistance training, a primarily anaerobic activity, is capable of mobilizing fat stores into the bloodstream from storage areas. Carbohydrates are the main energy source while lifting, but during the recovery period, it is mostly fat that is burned as fuel.
  • Interval training—alternating short periods of intense effort with longer periods of recovery—trains the body to become metabolically flexible and shift between the fuel sources, as the arduous effort burns mostly carbohydrates while the recovery burns mostly fats. 
  • Any intense physical activity will produce positive changes, whether it is heavier weights, faster efforts, and longer or more frequent workouts.
  • The foods that fill us up fastest and satisfy hunger longest are high quality, high-fiber carbs (whole grain pasta, whole grain brown rice, whole grain breads, legumes, whole fruits and vegetables); lean protein sources (easy on meat and dairy); and healthy fats (vegetable and seafood-origin)
  • Cut carbohydrates to decrease insulin levels and increase fat mobilization—especially sugar, simple white carbs, liquid calories and high fructose corn syrup.
  • Avoid giant meals in which the caloric load will be stored as fat; substitute with multiple smaller meals in which the calories will be used for immediate energy.
  • Eat slowly and savor food to minimize overeating.
  • Home cooked, non-processed meals are virtually our only means to ensure that we are getting wholesome, high-quality nutrients without hidden calories.
  • Limit after dinner snacking—that way we will burn fat during sleeping and not the fuel contents of our nocturnal nosh.  If we restrict our evening snacking to one piece of fruit, we will wake up in the morning with less to pinch on our waistlines.  This will also help prevent the sleep disturbance from having to digest foods when going to sleep.
  • Get adequate amounts of quality sleep, since sleep deprivation causes decreased levels of leptin (our appetite suppressant), increased levels of ghrelin (our appetite stimulant), increased levels of cortisol (causesincreased glucose levels and promotes fat deposition).
  • Minimize stress to minimize cortisol release; if you can’t eliminate it, manage it.
  • Caffeine can potentially ramp up our metabolism, in addition to boosting athletic performance and helping focus.

Andrew Siegel, M.D.

Author of Promiscuous Eating: Understanding and Ending Our Self-Destructive Relationship with Food

www.PromiscuousEating.com

Now available on Amazon Kindle