Internal Medicine Of Southwest Florida Newsletter
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Generic Medications
Weight Management at Internal Medicine of Southwest Florida
Recipe for Magnesium
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Dr. Raymond Kordonowy MD
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Issue: #9 August/September 2010

This issue of the newsletter features articles about a common cause of abdominal pain, generic medications, and weight management.  I explain some of the nuances of the prescription process. The last article discusses magnesium and provides a simple way to save your pumpkin and squash seeds so you may have a tasty way to take in magnesium.
I hope you enjoy this newsletter. As I write these newsletters, I continue to be impressed with the wide array of services our group can offer to the community. We hope we can continue to deserve the honor of helping in maintaining your health.  When ill, I also hope our group can get you to a timely diagnosis and treatment plan to getting you better!
Gallbadder and Viscera- Netter Upper Abdominal Pain

"Doc, my stomach hurts- bad!"  Abdominal pain is always a very worrisome symptom.  The causes of abdominal pain are numerous.  Some are benign and will resolve with time. Other conditions can be very serious and life-threatening.  Gallstones and gallbladder duct obstruction run the entire spectrum - from very benign/normal prognosis to life-threatening complications.  Gallstones and gallbladder disease are discussed in the following paragraphs.

What Causes Gallstones?

The gallbladder lives in the right upper part of your abdomen/belly.  It is situated just under/beneath your liver. The gallbladder stores and concentrates bile. Bile serves to help regenerate broken red blood cells, provide bile salts for fat digestion, and is involved in cholesterol transport and recycling.

The vast majority of gallstones are due to unfavorable chemistry of cholesterol. Basically if cholesterol can't be kept in a dissolved state, the cholesterol can crystallize and provide a starting point for stone formation. If crystals enlarge to any appreciable size, then gallstones now exist.  If gallstones develop slowly and don't interfere with the pathway for bile movement, persons will have no symptoms or complaints.  Gallstones can be incidentally found when imaging tests such as ultrasound or CT scanning is performed on a patient.

How Common is this Problem?

The prevalence of gallstones are between 5-64% in adults. The lowest incidence of gallstones is in black males (5%) and highest in Native American women (64%).  When physicians note gallstones in persons who don't have symptoms related to them, we advise nothing be done about this because the probability of developing symptoms are only 1-2% per year.

Do I Have Gallstone Problems?

The most common presentation of symptomatic gallstones is pain. Pain usually occurs due to intermittent obstruction of the bile duct (cystic duct) which is narrow "tube" that provides a pathway for bile to be released into the small intestine for helping in digesting fat. The pain of cystic duct obstruction is poorly localized but typically is in the upper center or more classically in the upper right abdominal area.  It is a steady/persistent pain that last 1-6 hours and often follows eating, especially fatty/rich foods. Often the obstruction will resolve on its own and the patient suddenly feels better- sometimes a vomiting spell resolves the pain. If pain or obstruction goes beyond 6 hours, then gallbladder pressure builds leading to distension, swelling and inflammation of the gallbladder. This is known as cholecystitis. If a patient develops cholecystitis and is quickly diagnosed, placed on bowel rest, fluids and often antibiotics, the problem may resolve on its own. Sometimes, depending upon the patient's other medical problems, no further intervention is recommended.  If a second attack does occur then removal of the gallbladder is recommended (see cholecystectomy below).

From Bad to Worse

In cholecystitis symptoms progress and worsen. The patient will begin to develop fever, nausea and sometimes vomiting. The pain intensifies and often will radiate to the right scapula (the 'wing bone in the upper part of your back). When a patient has this condition they usually take themselves to the doctors office, walk-in clinic, or emergency room. 
Acute cholecystitis can lead to further and more serious complications such as ascending infection of the liver bile ducts, gangrene of the gallbladder with infection of the blood stream, or inflammation of the pancreas (pancreatitis).  These developments are life-threatening and require hospitalization, antibiotics and acute drainage/release of the obstruction. The diagnosis of these complications and the procedures involved are beyond the scope of this article but often require a team approach involving Radiology, Gastroenterology, General Surgery , and Internal Medicine/Infectious Disease.

The Cure - A Chance to Cut is a Chance to Heal

Cholecystectomy is surgical removal of the gallbladder. In the "old days" this was done with a open procedure involving a 6 inch incision to the right upper quadrant and was a big deal due to recovery time.  Typically the patient required 1-2 days in the hospital and 4-6 weeks to fully recover.
Laparoscopic cholecystectomy involves performing this procedure through (typically) 3 puncture wounds. The benefit to this procedure is it is far easier on the patient. Typically patients are discharged the same day as the procedure (same day surgery) and are usually eating the same or by the next day. The complication rates between open surgery and Laparoscopic gallbladder surgery are slightly higher for the laparoscopic surgery but varies by surgical experience and serious complications are very low for both procedures. About 5% of laparoscopic procedures have to be converted to open if certain complications or findings are noted during the procedure.

Do I Really Need My Gallbladder?

Many patients wonder what happens if the gallbladder is removed.  Approximately 20% of the patients will note diarrhea which might persist for weeks but usually does resolve. There will be more and worse diarrhea if they eat fatty/rich meals and this makes sense. The bile salts released from the gallbladder are used to help digest fat. With the gallbladder gone, no storage of bile can occur and thus bile is slowly excreted into the small intestine. Only small amounts of fats can be digested at a time. If too much fat is eaten at once, diarrhea will occur. Oil/fat is very cathartic (remember when Mom would give you caster oil for constipation?).
Generic Medications
Generic Pills Prescription Issues

As the 3rd party system gains more control of the payment process, patients and doctors are being forced to switch to generic options. This dynamic is driven exclusively for cost reduction and hence profit motive for the insurance industry. As we are forced to deal with this dynamic I believe it is important to discuss the generic option. 

What is a Generic Medication?

When the average consumer learns about a medication (usually now by advertising) they become familiar with the branded (and patent exclusive) name.  All branded medications have a generic (chemical) name as well.
When discussing generics as it relates to prescriptions I am referring to the options of non patented/same medication as the branded name. For illustrative purposes an example is Zocor (brand name from Merck) and its generic name simvastatin (numerous manufacturers).

Value is Important

I feel it is important for the patients of IMSWF to know that the physicians in the group have historically always been value driven when it comes to prescriptions. 

Questions that should be reviewed at each and every evaluation include: 

Is medication is necessary?

Is the patient having untoward side effects to any prescriptions?

Are they getting benefit from the therapy recommended?

Do the physician and the patient agree on their current active medication list?

When choosing a prescription for a patient, the first issue is to confirm it is necessary.  The physician then picks the product for their patient. The decision as to what is prescribed includes an analysis of other medication problems, drug allergy or intolerance history, FDA approved options, ease of compliance/tolerability, and cost of therapy.  Physicians realize that taking a prescription is a cost commitment for any individual.  The price of the product is a significant factor.  In order to help consumers evaluate prescription medication, Consumer Reports (and others) now provide evaluation and recommendations for various medication drug classes and diseases.

Our group's  Electronic Medical Records (EMR) system allows us to see the average daily wholesale cost of any prescription written.  It shows the "ballpark figure" for the cost the cash-paying patient will pay for the recommended medication. As new medications are developed often competing manufacturers will develop similar (but not exact) compounds and seek FDA (patent) approval.  When a new medication class is developed there are often 2-5 branded products competing for the same market or disease indication. Such competition is healthy for the consumer.
With patent protection all competing medications within the same class charge very similar prices.  This is why even in the presence of competition, price is the least important competing issue - until the patent expires!  Nonetheless, there is some price difference and this is a factor the physician is aware of as new products come to market.  The prescribers are in effect the initial "consumers" of any newly patented medication.  Even though doctors aren't directly consuming the product- they are your advocate deciding value for you.  Prescribers look at actual price, ease of use, company legacy for safety and ethical delivery of prior products, side effect potential, and ultimately the anticipated positive effect on the treated disease.

Enter the Third Party Payer

I am always chagrined to see that even though I have picked the lowest priced product within a drug class for "Mrs. Jones" (if she paid actual cash for it), her prescription plan is denying payment for the prescription because they have a less expensive (for the plan) option.  Apparently the prescription plans get special deals/concessions from the manufacturer or distributor of products that is different than the average wholesale price.  There is no way for any physician to know this.  While the doctor might be choosing the least expensive product for retail sales, a patient's prescription plan may be getting a different deal.

Why Not Generics From the Start?

The generic approval process is very confusing and follows a convoluted chain of events. Basically, drug patents were legislated in order to provide incentives for the drug industry to pursue developing medications. Since medication development is FDA regulated and since we scientific physicians wish to have proven and safe therapies for our patients, the cost of developing a medication is very expensive. Drug patent law provides 20 years of exclusivity from the date of filing for application. Often it takes several years after that application for a medication to reach the market and thus the time a medication is on the market with no competition varies widely.  Price protection doesn't help the consumer but in the interest of promoting medication development,our society has allowed for it.
The balance that patent protection has provided has resulted in great advances in medication therapy.New medications lose almost half of their patent protection before they ever make it to the market. In order to help facilitate the ease in which generic companies could enter into the prescription drug market the Hatch-Waxman Act of 1984 was legislated. If you wish to read more about this legislation in detail you may link to the Hatch-Waxman Act.

Help Us Help You (Jerry Maguire)

This final paragraphs explain some of the ways in which IMSWF tries to help you, the patient, keep track of your medication list. A formulary is a list of covered medications that is unique to each competing prescription provider/plan. We would ask you to keep a current copy of your prescription formulary in your possession and bring it not only to our office appointments but recommend you bring it to all physician, hospital, urgent care and emergency room visits if possible.  If a provider knows your preferred medication list from the beginning of prescription shopping, usually he/she can agree on a preferred option within the boundaries of your plan.  Getting it right from the beginning will prevent a lot of delays, additional costs and hassles. If your prescription plan doesn't provide you with a copy of your formulary I suggest you request a hard copy from your plan. Each year request an updated one be provided.

The group uses a visit summary which is usually printed at the end of every visit to help keep the patient informed of any deletions, additions or changes to their prescription plan. I encourage all of our patients to spend a few moments reviewing and verifying their medication list after each visit. The doctors and nurse practitioners do wish to know if you are on medications (perhaps prescribed by another provider) that aren't on our list.  If a medication is stopped, please inform your prescription plan of this change.
E-prescribing... a Work in Progress

E-prescribing is a new method of electronically prescribing medication that is HIPAA compliant. This is different than faxing. It involves a two way communication between the filling pharmacy and the prescriber to verify prescription orders. It will eventually eliminate the paper process for prescription communication.
Currently there is no easy way for prescribers to inform your pharmacy or mail order company of any medication discontinuation. This inability to inform your pharmacy or prescription mail order provider is a major flaw in the current e-prescribing process. I have personally informed the designers of the e-prescribing process that this needs to be worked out as this government mandated program is further developed.
Obesity and Weight Management
Medical ScaleObesity Defined

Obesity is considered a medical disease. It is defined by something called the Body Mass Index (BMI). The BMI is calculated by a formula dividing mass (weight) by height.  A BMI of 30 or greater is the medical definition of obesity. Being obese increases a person's chances of developing diabetes (type II) with the top 10% of  BMI subjects carrying a 40-50 fold increased risk compared to the lowest 10% of BMI. 

Overweight is defined by a BMI of between 25-29.9.  Numerous conditions including hypertension, certain cancers, heart attacks, need for knee replacement are significantly more prevalent if a persons BMI is 27 or higher. I recommend persons strive to have a BMI at least under 27 as a first goal for desired weight. 

Fat is a Hormonal Factory

Physicians used to believe fat was just a storage place for excess and reserve calories.  As the relationship between weight and diabetes (and another serious "diabetic equivalent" known as metabolic syndrome) is studied in more detail, the scientific community is beginning to understand that fat is not only a storage place for excess calories but it is actually a hormonally active organ system. Numerous active chemicals are being secreted and regulated/altered by the fat system. I am confident that as science understands the various relationships in more detail, medications that are specific to helping with the regulation of appetite and fat storage will be designed to manipulate this fat organ.  I had mentioned in our last newsletter the endocannabinoid system as it related to marijuana. This is one of the systems that has receptors and activity in the fat, muscle, gut, and brain tissues of humans.  This system is being targeted for weight management medication and there is currently a product prescribed in Europe but not FDA approved in the US due to concerns about depression illness with the medication.

Not all fat is equally hormonally active.  The fat around a person's belly/waist and abdominal cavity is worse on cardiovascular risk than the fat around the legs and buttocks. 

Waist Circumference vs. BMI

A recent article in the Archives of Internal Medicine demonstrated that waist circumference (a measure of abdominal obesity) is associated with higher mortality independent of the BMI. After adjusting for BMI and other risk factors, very high waist circumference levels were associated with about a 2 times increase risk for mortality in men and women.
Our Solution

The physicians of Internal Medicine of Southwest Florida are aware of the local increase in advertisements for quick and easy weight loss programs. Such methods of weight management do get quick results but ultimately fail to help people with long term success. The rapid weight loss services presently in fashion are using stimulant medications to blunt the user's appetite. These medications are not appropriate to use in persons who aren't medically obese or significantly overweight with additional health risk. There are serious potential complications of such medications and certainly in older subjects the risks are higher.  
Due to this fad and contrary to my normal position, I have recently run a print ad to offer people what I believe is a much better method.  For over a year IMSWF has had a registered dietitian on staff. Dietary counseling is imperative for long term success. Obesity is a medical disease and thus if we order dietitian services for our obese and overweight patients this is a covered service under Medicare part B and most insurances. For persons who fit the definition of obesity and fail at dietary and behavior modification alone,  I do prescribe the FDA approved medication known as Meridia in conjunction with diet and behavior modification.  Often, I will recommend patients use tailored meal or snack replacement nutrition to keep control of calories while benefiting from protein and vitamin enhancement.  When restricting calories, vitamin supplementation may reduce food craving.  If a person is lacking an essential vitamin, the body will have an overwhelming drive to seek food to fix the problem, leading to cravings and binging.
Lose Weight by Breathing?

IMSWF has on site the ability to measure the caloric requirements of an individual by measuring expired carbon dioxide. Using a machine called the ReeVue Indirect Calorimeter by Korr the group can quantify your caloric needs and personalize the amount of caloric restriction.  Often you don't need to deprive yourself of as many calories as the "one size fits all" programs currently being advertised. 
Internal Medicine of Southwest Florida has a Certified Dietitian on staff to help us manage overweight and obese patients. Marcy Russo is also certified in diabetes dietary management as well. Currently Marcy is keeping office hours Tuesdays and Thursdays. Marcy is also helping us in patient dietary counseling as it relates to cholesterol/lipid disorders (Lipidology) as well.
Don't Throw Those Squash Seeds!
Roasted Squash SeedsPumpkin and squash seeds (as well as squash flesh) are rich sources of magnesium.  When in season my family makes pumpkin soup and year round we enjoy squash.  This newsletter is from yours truly (I often wing it in the kitchen) and involves roasting your squash or pumpkin seeds for later snacking instead of tossing them in the trash.

Roasted Squash/Pumpkin Seeds

Scoop out the seeds of your squash or pumpkin.  Acorns, butternut or any of the others that have good sized seeds will work. I use a colander with plenty of rinsing to get the seeds separated from the flesh.  Lay the seeds evenly in a flat cooking sheet or a baking bread pan. You may pat them dry and clean using a paper towel - this will result in less oven time. Drizzle vegetable or olive oil (I use a pump sprayer) over the seeds.  Add a sparing amount of Kosher salt and or a very light amount of nutmeg for flavoring. Bake at between 175-325 degrees in a partially open oven (peak at them often) or grill until the seeds are the desired level of browned roastedness.  Store in a plastic bag or container  and nibble for a snack.  My family usually eats them up in one-two days of eating the pumpkin or squash.  Enjoy! 

- Dr. Kordonowy

Magnesium is a very important electrolyte.  It is noted to be low in approximately 12% of hospitalized patients. Symptoms of low magnesium include generalized weakness, muscle irritability and cramps and when very low changes in a patient's EKG and heart rhythm.  It is used as an intravenous bolus as therapy for a life threatening form of ventricular tachycardia known as torsades-de-pointe.  

We ingest approximately 360 mg of magnesium daily.  About a third of this is absorbed. 1/2 of person's magnesium is stored in bone, the rest in cells and tissue.  It is involved in over 300 biochemical reactions on the body. Only 1% is kept in our serum (blood stream).  Our kidney handles the retention and excretion of magnesium to keep it in balance.

Magnesium can get depleted by some diuretic medications such as lasix, and demadex (furosemide and torsemide are the generic versions respectfully). Persons who use a lot of alcohol are notorious for having magnesium deficiency.  Diabetics often have low magnesium levels that predate their disease and the reason for this is poorly understood.  It is possible that glucose elevation promotes wasting of magnesium (my theory) via a diuretic effect. The problem with my theory is that population studies suggest that low magnesium in peoples blood measurements occur before any evidence of significant glucose/sugar elevation is noted. Nutritional/alternative medicine references suggest magnesium may help diabetes but there is no evidence that this is true. In the past I recall reading studies that were conducted using magnesium replacement as a strategy to prevent or treat diabetes.  These studies failed.
I hope you find the topics and links interesting.  Understanding generics is very difficult.  I am hopeful that spending more detail on the prescription topic will result in more efficient and satisfying prescription experiences for all parties involved.  As we head into fall I hope you remember to roast your seeds and boost your magnesium!  As always it is a pleasure to serve you and Internal Medicine of Southwest Florida appreciates your patronage.

Raymond Kordonowy MD
Internal Medicine Of Southwest Florida
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