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Kalydeco: Science at Its Best

February 1, 2012 Dr. Pullen

I read with a personal interest the approval of Kalydeco (ivacaftor) this week for treatment of the 4% of cystic fibrosis patients carrying the G551D mutation. My first wife Lenore had cystic fibrosis and died at age 26. At that time in 1983 we knew a great deal less about CF than we know now. The introduction of Kalydeco this week brings several key issues in health care to the forefront. Development of drugs to treat disorders with a limited number of patients to use the drug can make the cost to each individual seem crazy expensive. The specific direct targeting of Kalydeco at a specific gene mutation is possibly an indicator of personalized treatments for more common disorders in the future. The whole fast-track process used by the FDA in approval of Kalydeco is an example of their faster approval of some drugs working as promised.

In the years since Lenore’s death CF has been found to be caused by a mutation in the cystic fibrosis trans-membrane conductance regulator (CFTR) gene that regulates ion transportation (ions like chloride hence the traditional sweat chloride test for CF) and therefore fluid flow within cells. One specific mutation is the G551D mutation (substitution of aspartic acid for glygine at position 551), and the new drug Kalydeco specifically targets the abnormal protein in these specific CF patients. Kalydeco helps the defective protein work more normally, and so reduces the abnormalities in CF patients with this specific mutation.

Unfortunately only about 1 in 25 CF patients have this specific mutation in the CFTR genetic code. The rest have some combination of the other at least 1000 known mutations. The most common CFTR mutation is called F508del (a 3 nucleotide deletion at location 508 leading to a missing phenylalanine amino acid “F”) and about 1 in 30 Caucasians have this specific mutation in the CFTR gene. Kalydeco is not effective in patients who are homozygous for the F508del mutation. This homozygous F508del mutation is the most common genetic code in CF patients. IN the 4% of CF patients with at least one copy of the G551D mutation Kalydeco has been shown to be effective in reducing CF symptoms, and is an exciting breakthrough.

Patients with the G155D mutation produce a protein that is able to make it to the cell membrane, where Kalydeco allows it to function much more normally. In patients with the F508del mutation the protein fails to fold in a way that allows it to move to the cell membrane, and so a drug like Kalydeco cannot function. Scientists are working on possible medications that could allow the migration of the other defective genes to the cell membrane where use in combination with Kalydeco could potentially be effective.

It is exciting not just for the 1200 U.S. patients with this specific type of CF, but also because it is an example of how genetic research, gene analysis in genetic disorders, and great basic science can lead to novel therapy for genetic disorders.

The rapid approval of Kalydeco is a great example of the new expedited FDA approval process for drugs that have the potential to be novel or breakthrough products where there is currently no effective therapy, or the drug is a major advance in therapy. It took only 3 months for Kalydeco to get FDA approval, even faster than the promised fast-track approval promised for special circumstance drugs.

The catch in this whole process is the incredible anticipated cost of Kalydeco. In a Wall Street Journal article the estimated annual cost of Kalydeco is reported to be $294,000. Since the anticipated number of patients eligible to receive this orphan drug is so small, and because of the novel and documented improvements demonstrated in patients using Kalydeco it is expected that insurers will pay for the cost of the medication. If all 1200 eligible patients take Kalydeco the annual cost at this price would be $353 million annually. Still this price is not Guinness world record. Two more expensive drugs are Soliris for a rare condition parosysmal nocturnal hemoglobinuria at $409K annually and Elaprase for the rare genetic disorder Hunter Syndrome , a polysaccharide storage disorder, at $375K annually. These are examples of orphan drugs with very limited markets where the cost of development is shared by very few patients.

I look forward to seeing more examples of genetic research leading to personalized medications for individuals.

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Risks of Defensive Medicine

January 25, 2012 Dr. Pullen

There has been a lot of criticism of defensive medicine as a major contributor to the rapidly rising high cost of medical care in the United States. Although the real financial cost of defensive medicine is one issue, it is not the only problem with defensive medicine. Defensive medicine also has the risks of incidental findings on tests that are unnecessarily ordered, the risks patients encounter due to evaluation and treatment of these findings, and overdiagnosis.

Screening for prostate cancer has been all over the news recently, with the USPSTF proposed recommendation against routine PSA screening, and is a classic example of the risks of screening tests. The strongest argument against PSA screening is overdiagnosis and exposure of men to invasive prostate biopsies, and potentially dangerous therapy for prostate cancers that will never become clinically significant in some unknown but likely high percentage of cases. One of the primary reasons I don’t anticipate a dramatic reduction in PSA testing in primary care is because it is perceived by physicians that they are much less likely to be sued for complications of care caused by overdiagnosis of prostate cancer than if a patient is diagnosed with advanced prostate cancer and who has not been offered PSA screening. I suspect at least some physicians are going to be afraid to do the right thing even if they are convinced that the evidence supports not doing PSA screening.

Far less emotional and dramatic are consequences of defensive medicine precipitated by the ordering of imaging tests. It is commonplace for a physician to order an MRI of a patient’s knee early in the course of management of a knee injury. In an NEJM study of randomly chosen men without a complaint of knee pain the incidence of finding a meniscus tear on knee MRI was 31%. A finding of adrenal masses on abdominal CT scan is very common. In one study the incidence of an adrenal mass finding on abdominal CT in patients without a known malignancy was 5%. In this same study of 973 consecutive patients of the 973 zero were found to be malignant. This is exactly my experience, i.e. I’ve never had one of these turn out to be a cancer. Yet once an adrenal mass is found it is almost always recommended as a part of the radiologists report to have it reevaluated at least one, often twice or more to assure “stability.” It is unusual for a primary care physician not to order these follow up tests, more defensive medicine. The risk of radiation exposure from abdominal CT scanning is not insignificant.

Treatment of sore throat, acute short-duration sinusitis, otitis media and acute bronchitis with antibiotics is very common. It may be defensive medicine or just taking the path of least resistance, but there are very real risks of antibiotic therapy and almost all the evidence and expert opinion argues against the use of antibiotics in these conditions. With the increasing incidence of Clostridium difficiele infections, and increasingly virulent and antibiotic resistant C. diff as well as the other risks of side effects of specific antibiotics their use is far from risk free.

Nearly every new highly sensitive imaging technique is also very good at finding incidental variations of normal and abnormalities for which radiologists are reluctant to recommend no further evaluation, This is defensive medicine on the part of radiologists, as well as good business on their part in our fee-for-service environment. What business person of sound mind is going to put themselves at legal risk and at the same time recommend against a test that is in their financial interest. The risk to patients is more than just the risk of further radiation. Often the tests also lead to invasive tests or treatments, all of which have their own risks.

Many blood tests have the same risks, including tests like CA-125 for ovarian cancer, of course PSA, but also things as simple as a CBC. A CBC with a low white blood cell count is usually either normal or the result of a recent viral illness. Still it usually leads to a follow up test to assure a return to normal. If it persists low it may lead to referral to a hematologist who often orders a bone marrow evaluation. These are not only moderately painful but can have uncommon serious complications.

Essentially every test or procedure we do entails some risk. Ordering tests for defensive medicine reasons when the chances of finding clinically important and helpful results is fairly low makes the chances of finding false positives or overdiagnosis and leading to complications that would never have happened if the testing had not been done relatively higher. The cost of defensive medicine is not just in dollars.

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Doctors Die Too, but Maybe Differently

January 23, 2012 Dr. Pullen

I stumbled across this terrific article titled:

How Doctors Die by Ken Murray a FP at USC.

It is largely anecdotal, but is a really an interesting perspective on how at least some physicians choose to forgo futile end-of-life treatments because they know the limits of modern medicine first hand.

Also Enjoy:

Octogenerian’s Letter to Santa

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Endemic Polio: Good News and Bad News This Week

January 18, 2012 Dr. Pullen

The Polio news this week was both very good, and potentially very bad. In Early Jan. 2012 India celebrated a year without a case of wild-strain polio, the first in its history and a huge achievement in a country with about a billion people and areas of extreme poverty and remote regions. Also this week Afghanistan was reported to have a 3-fold increase in the number of polio cases, from about 25 in 2010 to 76 in 2011. This will be a tragedy if not arrested, as there are only three countries considered still endemic for polio remaining in the world, but the entire world remains at risk until there is a complete eradication.

Afghanistan remains a challenge to immunize both because of it’s remote areas and because of its civil war. The Taliban are reported to have remained cooperative with immunization efforts, but in any country at war coordination and extraordinary safety measures must remain a constant barrier.

A nice article in the N.Y. Times discusses this issue and is worth the read:

After Years of Decline, Polio Cases in Afghanistan Triple in a Year

As a Rotarian and contributor to Polio Plus this remains an interest of mine. Also see previous posts on this topic:

Polio Eradication

Eradication of Polio: It’s Happening

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The Purpose of Progress Notes

January 9, 2012 Dr. Pullen

As a practicing physician I am responsible for making progress notes to document every patient visit. Over the years I’ve had to prepare progress notes as handwritten documents, as dictated documents that I had a transcriptionist type out, and for the last 15 years as EMR generated progress notes. Throughout this progression of technology in facilitating the compilation of progress notes several things haven’t changed. The first is that some providers really struggle to stay current on completing the progress notes. The use of an EMR seems to be here to stay and I believe the real key to staying current on completion of progress using an EMR as it was with earlier technologies is to do them at the time of the visit or as soon as possible thereafter. Waiting hours or even days before completing your progress notes not only makes it more difficult to make the notes accurate and useful but requires taking time to recall information that if the note had been done at the time of the visit would have been in the provider’s immediate recall. The other thing that has not changed is that whether we like them or not they serve three and I believe only three purposes.

This may seem overly simplistic or even crass but progress notes only serve three purposes:

Facilitate good patient care: The primary purpose of progress notes is to allow the provider and any other providers who may care for the patient the future to have the information they need to accomplish optimal care. In most cases this really is very little information. I remember early in my career a retiring physician asked me if he could send me some of his patients when he retired. I was a bit shocked to see that he kept his entire patient record on a single 5 x 8 filing card. It was written in pencil and he simply erased any no longer relevant information when he needed more room to write a new progress note. If a patient had strep throat he simply wrote a dated entry: “strep-penicillin.” It was quite clear that the patient had strep throat and was treated with penicillin and that’s really all anyone needed to know to provide good care for the patient. Needless to say although that progress note accomplished this goal it would’ve failed miserably for purposes 2 and 3 below.
Function as a legal document: Another important function of progress notes is to document care in a way that functions as legal document. As a physician today doing what it takes to avoid being sued for malpractice is a daily reality. We spend a great deal of effort and time documenting our care in order to try to make a case that our care meets standards of practice, and make our care defensible in case of a malpractice suit. This part of progress notes is usually simply detailing the history, physical findings and thought process behind treatment plans.
Get paid: In our third-party payment system the amount we get paid is based on the CPT code that we submit to the insurance company. Each CPT code for evaluation management services (this is medical coder talk for office or hospital visits) has documentation requirements to support that level of service. I won’t get into the complexities of this system but one purpose of progress notes is to include the language needed and the bullet points required for the level of service bill.

I think if physicians have a clear understanding that these are really the only purposes of a progress note it helps facilitate efficient charting. It also helps think about what each of our progress notes needs to contain. When a patient is seen for a very low risk condition and a low-level of service is being billed a brief note that documents what’s necessary to provide excellent care in the future is all it’s really needed. When higher levels of risk are involved a more detailed document to function in case of a lawsuit is needed. By deciding what level of service we plan to bill for the visit we can quickly decide how much documentation is needed to support that level of billing. In my experience most of the time primary care physicians obtain the history and to the physical examination required for higher levels of visit than they bill for, and much of this history and physical doesn’t need to be documented in progress notes unless a level of billing is used that requires that documentation.

Use of an EMR can make entering a great deal of information into progress notes very easy and one of the drawbacks of EMR’s is that the progress notes produced tend to be much longer and include information not helpful for patient care. It’s easy to understand why EMR’s are used to do this level of documentation when you look at the advantages of this documentation for purpose number three (Get Paid). The trick is to leave out information not needed for any of the three purposes above, and not insert lots of EMR generated details just because it’s easy to do and it’s better to have more information that an auditing insurance company, or worse governmental payer wants to see to justify the CPT code submitted. This excess data can actually detract from the usefulness of the progress note’s function #1.

You may also enjoy: APSO Notes Need to Replace SOAP Notes in EMRs

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How Safe is Oral Sex?

December 12, 2011 Dr. Pullen

Bill Clinton didn’t consider it sex. Lots of teens today consider oral sex a safe alternative to intercourse. Headlines like on ABC news in 2009 cry out, “Oral Sex is the New Goodnight Kiss.” Data suggests that oral sex is becoming more common practice in teens than vaginal intercourse, a major change from a generation ago. In 2002 up to 24% of males and 22% of females teens who had never had vaginal intercourse reported having had oral sex with an opposite sex partner (1). In addition gay men want the real truth, is oral sex a safe alternative to more risky behaviors? The answers seem to all be relative. There are few absolutes in life, but one of the truths is that the only way to completely avoid risk of an STD is to avoid any type of sex. That said, how safe, or alternatively how dangerous, is oral sex?

Let’s look at the evidence for transmission of the various STDs by oral-genital contact.

HIV: Human Immunodeficiency Virus, the cause of AIDS, is the STD many fear most. It can be transmitted when a body fluid containing the virus gains access to another person’s mucous membranes or bloodstream. Unquestionably HIV is transmitted by anal and vaginal intercourse. There are at least a few cases where it is believed that the HIV virus was transmitted to the receptive partner after oral sex with ejaculation. Oral sex without ejaculation into the mouth is theoretically possible, but is felt to be extraordinarily unlikely. The risk of contracting HIV from a single incidence of anal intercourse with with ejaculation and no condom use with an HIV infected male has been estimated at 1:100. Extensive study has been done in trying to find out what the incidence of contracting HIV from oral sex with ejaculation with an HIV infected male, but these studies all have confounding variables. The real problem is that all of these studies have been in gay male populations, and a low percentage of the men had only oral sex. On second and subsequent interviews many times the history changed, and made other routes of transmission more likely. In one study it was estimated that there were zero cases of conversion in a population after over 35,000 incidences of oral sex. All said, although it is possible to contact HIV from oral sex, the chances are very low. Low enough that if oral sex is a behavior that replaces anal intercourse in gay men the benefit of avoiding the high risk behavior likely greatly outweighs the risks of oral sex in this situation.

Herpes Simplex: This may be the most common STD transmitted by oral sex. Up to 70% of teens are estimate d to have been infected with the herpes simplex 1 virus, the cause of >90% of oral herpes cases. Many others, and many of the same people also have been infected with the herpes simplex 2 virus, the cause of >90% of genital herpes. The problem with herpes simplex is that despite popular belief, an infected person can shed the herpes virus at times when they have no symptoms or visible evidence of infection. It is believed to be fairly common to transmit the herpes simplex virus either from the mouth to the genitalia, or from the genitalia to the mouth during oral sex. The incidence of HSV transmission by oral sex is not well studied.

Gonorrhea: Gonorrhea, caused by the bacteria Nisseria gonococcus, is an STD that typically causes painful urination and a discharge of pus from the urethra in men. In women it can be asymptomatic, can cause a vaginal or cervical discharge, or can cause more serious infection of the fallopian tubes and or ovaries, called Pelvic Inflammatory Disease (PID). Gonorrhea can also infect the throat or tonsils. The route of this infection appears to be oral sex, generally receptive oral sex with the penis in the mouth. It is less clear whether cunnilingus can transmit gonorrhea although it is felt that this is very rare if it ever happens. Men likely only contact gonococcus from vaginal or anal intercourse or from an infected partner during receptive oral sex.

Chlamydia: There is less data about transmission of Chlamydia by oral sex. It is generally felt to be possible to transmit Chlamydia both as the person performing and the person receiving fellatio. The incidence of this is just not known.

Syphilis: Syphilis is fairly uncommon in the US, but transmission of syphilis during oral sex is relatively easy, and is felt to be a relatively common cause of transmission, possibly up to 15% of cases in some areas of the US.

HPV: HPV is probably the most prevalent STD in the world today. The HPV virus can be transmitted to the throat or mouth during oral sex. The incidence of this is poorly understood, but there is an increasing rate of HPV positive head and neck cancers in the last 30 years. Many experts feel that this correlates to increasing acceptance of oral sex. Oral cancer has historically been primarily a disease of older adults with a long history of smoking and drinking, or in younger persons who use oral tobacco. In recent years the incidence in younger non-tobacco users has increased, and many of these cancers are HPV positive on testing.

Hepatitis: There is debate whether hepatitis B can be transmitted by oral sex, but if possible it is felt to be very unlikely. Hepatitis A can clearly be transmitted by oral-anal sex, and is much more common in the gay male population than in the heterosexual population.

In summary oral sex is not safe sex, but it is far less risky than either vaginal or anal intercourse regarding STD transmission. In addition the risk of pregnancy in heterosexual oral sex is near zero. Avoiding receiving ejaculate in the mouth greatly lowers the risk of transmission of HIV, though probably not the risk of herpes, gonorrhea, or HPV. Condom use for men, or use of a dental dam in women seems effective in markedly reducing the risk of most STDs with oral sex, but may not be common practice.

Psychological Issues: Oral sex is clearly an intimate act. Most psychologists agree that sex, either oral sex or sexual intercourse, brings a relationship to a different level. How this type of intimacy affects a relationship, the self esteem of the participants, and future feelings about relationships and intimacy are subjects worthy of consideration, but I know of no research into this topic.

So, “How safe is oral sex?” What do you want to tell your children about oral sex as a part of their sex education? You can decide now based on the discussion above and whether it involves men having sex with other men (MSM) vs. heterosexual oral sex. One risk of labeling oral sex a high-risk behavior in MSM is that it may leave gay men feeling that its risk is equal to anal intercourse, which is far from the truth. If oral sex is an alternative to anal intercourse for MSM then it greatly reduces the risk of HIV transmission.

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Medications as a Cause of Emergency Hospitalizations in the Elderly

December 8, 2011 Dr. Pullen

According to a recent New England Journal of Medicine article close to 100,000 Americans of Medicare age are hospitalized annually from medication related conditions. You might at first think that these are due to overdosages of prescription pain killers or abuse of other prescription medications, but in fact just a relative handful of types of medication lead to most of these hospital admissions. In addition the very old were especially at risk, with half of these admissions in patients over age 80, and about 65% were due to unintentional overdosage of the medications.

Not surprisingly warfarin leads the list and causes almost 1/3 of medication related hospitalizations. I’ve discussed warfarin in an earlier post on medications with a narrow therapeutic window. Next in line was insulin, which led to 14% of the admissions, likely due mostly to hypoglycemia and the attendant problems like seizures and coma. Anti-platelet drugs like aspirin and clopidogrel (Plavix) was next at 13%, and oral diabetes medications next at 11%.

Combined these medications led to >2/3 of medication related hospitalizations in the elderly. How can you avoid these mishaps?

If you are on warfarin be sure to understand the nuances of the drug regarding diet, medication interactions, and be sure to follow through with your recommended anticoagulation clinic visits.
Use a weekly medication container to place your medications into to avoid duplicate doses of medications and unintentional overdoses.
With diabetes medications like insulin and oral medications be sure to let your physician know if you are having low blood sugar problems, know how to manage days when you are sick or unable to eat regularly, and work hard to avoid being in situations where you are not able to eat properly.
With anti-platelet drugs avoid excess alcohol, use of other NSAID products, and let your physician know if you are having acid-dyspeptic symptoms or note blood in the stool or emesis.

Even if you do everything right, know that these medications have inherent risks, and don’t hesitate to seek medical attention if you develop problems with the meds. Also be sure to let any physician treating you know that you are on these meds. Consider carrying a current medication list to give to any physician you see so they can keep your medications in mind when they treat you.

The Gluten Free Marketplace Explodes

December 5, 2011 Dr. Pullen

The Gluten Free Marketplace Explodes

Gluten Enteropathy, or celiac disease (sometimes called celiac sprue), is a condition where the lining of the small bowel is damaged by antibodies to gluten found in wheat, rye, barley, malt and some other grains. When people who are gluten sensitive eat food containing gluten their small bowel becomes inflamed, the villi that contain enzymes to help digest foods to allow their absorption become atrophic and dysfunctional, and they lose weight, become ill and just feel terrible. For many years it was felt that gluten enteropathy was rare in the United States, and was primarily a European problem. As late as 1999 the teaching in U.S. medical schools was that only 1:10,000 Americans had gluten enteropathy. Beginning in the early 1990’s research began to show that the incidence was much higher, and it is now estimated that as many as 1:100 Americans has gluten sensitivity. This for unknown reasons seems to be a real increase in the last half century, and not be just a product of increased awareness and better testing.

Gluten sensitivity can be dramatic or subtle, and difficult to diagnose. A battery of blood tests often including Anti-tissue Transglutaminase Antibodies(Anti-tTG) IgA, Anti-tG IgG, Anti-Gliadin Antibodies, Anti-Endomysial andibodies, or other antibody tests if positive can suggest the diagnosis. A negative test has a higher predictive value at ruling out celiac disease than a positive test has at confirming the diagnosis (the tests are more highly sensitive than they are specific). To confirm the diagnosis requires a small bowel biopsy that is usually obtained by upper GI endoscopic exam.

Once diagnosed with celiac disease a person has to learn how to eat a gluten free diet in a society where wheat and other gluten containing food is nearly everywhere. Fortunately more and more prepared foodstuffs are being marketed all the time, and more recipes, support groups, and nutritional advice is available than ever before.

I just read a very interesting article in the N.Y Times by Keith O’Brien that nicely outlines the history of the emergence of gluten enteropathy in the U.S., and the market leadership by General Foods in bringing gluten free food products to market to capitalize on the growing market for gluten free products. You may enjoy reading:

Should We All Go Gluten Free?

By Keith O’Brien November 25, 2011.

My guess is that you know someone dealing with the need to eat gluten free. Fortunately as awareness grows and resources become more easily available providing a gluten free meal is less onerous than it was just a decade ago.

I am also learning more about various nutritional deficiencies that can accompany celiac disease. The malabsorptive condition seen in patients with celiac disease can lead to several well documented vitamin deficiencies that are uncommon otherwise. Deficiencies in almost all of the fat soluble vitamins and B vitamins are more common in celiac patients than in the general population. I recently saw a 17 year old girl in the office with known celiac disease who had been well controlled on a gluten free diet for several years. She was found to be both vitamin B12 and folic acid deficient when evaluated for anemia and fatigue.

As a medical community we have become more aware and educated about celiac disease in recent years, and it is good to see that the marketplace is stepping up to meet the demand for gluten free products and make existence easier for this significant minority of Americans with gluten sensitivity.

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Why Quit Smoking?

November 17, 2011 Dr. Pullen

This post is in appreciation of the 35th anniversary of the first “Smokeout”, actually the November 18, 1976 “Don’t Smoke Day” (D-Day) in San Francisco sponsored by the California Division of the American Cancer Society which received national (all 3 major national networks at the time ) and became a national event thereafter. The third Thursday of November each year, just one week prior to Thanksgiving is the Great American Smokeout. About 45.8 million Americans still smoke and most studies show more American smokers would like to quit smoking than those who don’t want to quit. Here are some great reasons to quit:
1. Retire Early(or take a nice vacation every year) on the Savings: If you smoke 1 pack of cigarettes a day for a year, at an average cost in Washington State where I live and work at the average cost in WA of $9.89/ pack you spend $3609.85 a year on cigarettes alone. If saved the 3609.85 annually and invested it at only 4% you would have $111,794.17 in 20 years. It would be more if you invested daily or monthly. Quit smoking now and you can be a long way towards a retirement fund. You may also live to retire. (I admit Washington is the second most expensive state to buy cigarettes in the U.S.)
2. It Stinks: Any non-smoker can tell you that they can smell the odor of cigarettes on your clothing, hair and body from several feet away. By quitting smoking you will avoid smelling repulsive to the majority of others in society.
3. Live Longer and Better: The average smoker dies 7 years earlier than the average non-smoker, and estimates of the time lost per cigarette smoked is 7-10 minutes per cigarette. The whole issue is really much more complex that this, but without doubt quitting smoking can add significant time to the average person’s lifespan.
4. Better Sex for Longer: Smokers have a much higher incidence of peripheral vascular disease, and erectile dysfunction is often the result of vascular disease. Quitting smoking can lead to a better sex life for many smokers.
5. Dying of COPD is Among the Worst Ways to Die: This is my personal opinion, but I’ve taken care of people who have died nearly every common cause of death. Respiratory failure has to be among the least desirable way to die. Being essentially immobile, gasping for air while on oxygen for months or years, and finally dying of a respiratory infection that leads to inability to breath is not among the ways I hope to die.
6. Get Your Kids/Grandkids/Spouse/…. Off Your Case: Nearly every smoker I see in the office comments that their loved ones are hoping the get them to quit, and often annoying them with encouragement and pestering. Why not change all that to congratulations and positive reinforcement after you quit?
7. Feel Proud that You Quit: Most smokers would like to quit smoking. Most who do tell me that they are happy and proud that they were able to quit. Join the ranks of proud ex-smokers.
Please leave comment with more and better reasons to quit. I’d love to have this post be a place for smokers to find the right reason for them and quit themselves. There is no time like today!

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The Real Costs of Defensive Medicine

November 15, 2011 Dr. Pullen

by Brittany Lyons

With estimates ranging from $35 billion to a whopping $850 billion, the true costs of “defensive medicine” are difficult to pinpoint. A variety of government reports, physician surveys and studies have attempted to pinpoint exactly how much of U.S. healthcare costs are generated by defensive medicine, but the varied definitions of “defensive medicine” make the real number hard to determine.

Defensive medicine refers to the costs associated with doctors protecting themselves from medical malpractice lawsuits. These costs include liability insurance premiums, malpractice judgments and settlements, and sometimes extend to unnecessary testing or other physician services provided to patients solely to avoid malpractice claims. Indirect costs associated with defensive medicine can also include “assurance behaviors,” such as ordering tests or delivering additional services that have only marginal medical value, or no value at all, to discourage malpractice lawsuits—which can cost more than even earning PhDs. A 2005 study published in the Journal of the American Medical Association discovered that doctors may perform these unnecessary services in the hopes that if a malpractice claim were to arise, the court would be satisfied that the physician met the standard of care.

A Look Behind the Numbers

The Congressional Budget Office estimated that defensive medicine accounted for $35 billion—or 0.2 percent—of the total U.S. healthcare expenditures for 2009. This figure is significantly lower than the estimated $650 to $850 billion in annual expenditures attributed to defensive medicine by Gallup and Jackson Healthcare surveys of physicians. The Jackson Healthcare survey gathered data from thousands of physicians across the United States on the indirect and direct costs generated by defensive medicine, concluding that physicians considered defensive medicine the primary driving force behind rising healthcare costs—the result of an overly litigious healthcare environment.

Nine out of ten surveyed physicians said they practice defensive medicine, and general estimates predicted an average of 34 percent of overall healthcare costs arise from defensive medicine. A subsequent Gallup poll of physicians found that approximately 73 percent of surveyed physicians admitted to practicing defensive medicine within the past year, but estimated overall costs at only 26 percent. The 2005 JAMA study by researchers from Columbia and Harvard Universities also revealed that for physicians practicing in “high-risk” specialties, these monetary figures may be much higher; 59 percent of the physicians surveyed admitted to ordering more diagnostic tests than medically necessary to prevent malpractice litigation. Plus, the physicians avoided caring for high-risk patients, referred patients to other specialists, prescribed more medications than medically necessary and suggested unneeded invasive procedures—all to avoid malpractice lawsuits. Another study by the American Academy of Orthopedic Surgeons discovered that defensive medicine accounts for a startling 20 percent of all imaging orders, and half of these imaging orders were for expensive MRIs.

Why the Disparities?

So why is the Budget Office’s number so low when the Jackson Healthcare survey is so high? Because physicians aren’t regularly logging every single expenditure arising from defensive medicine, and no one is entirely sure what even qualifies as “defensive,” quantifying the costs with exact accuracy is nearly impossible. The great differences in estimated costs, however, is likely due to the particular expenditures included in the figures for defensive medicine. For instance, the CBO’s low estimate of $35 billion includes “malpractice insurance premiums together with settlements, awards and administrative costs not covered by insurance,” but does not include unnecessary procedures, medications and other services, so long as they are covered by insurance. This difference in accounting is more than enough to explain the disparity.

The Jackson Healthcare survey adds a myriad of other direct and indirect costs to the CBO’s numbers, including all the excessive diagnostic testing and medical services provided in the spirit of defensive medicine. The survey results then translate the percentages into dollar amounts using the calculations of estimated overall U.S. healthcare spending released by the Centers for Medicare and Medicaid Services. Thus, this number includes more items than the CBO’s report, and bases its numbers on another estimate.

With healthcare costs rising rapidly in the United States, combined with increasing tort reform and malpractice fears, defensive medicine is becoming a more and more expensive slice of the healthcare-cost pie. Regardless of the actual monetary amount, defensive medicine practices strain not only Medicare and Medicaid, but also the insured and uninsured healthcare consumer alike, contributing to increasing prices for medical services and greater costs to insurance companies. Unless something is done to relieve the legal pressures placed on physicians, defensive medicine will continue to generate billions of dollars in healthcare expenditures every year.

Brittany is a blogger-in-residence at PhDs.org