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.

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.

The exact mechanism of action of Latisse is not clearly understood but it appears to be a prostaglandin receptor binder . Prostaglandin receptors are present in here and is thought that prostaglandin receptors are somehow involved in the development and regrowth of hair follicles.

Latisse® is a prescription only product that is designed to be applied once daily to the base of the upper eyelashes with a single use a sterile applicator. Despite the intention to make Latisse® prescription only,  much like other drugs for which patients might wish to use but don’t want to get a prescription to see a physician about Latisse® is widely available online without direct physician supervision. This is unfortunate because the teeth can have very annoying and potentially permanent side effects. These include a plum shade discoloration of the eyelid, macular edema which can be very serious even lead to blindness, a condition called punctate epithelial keratitis which can lead to significant itching and irritation of the eyes, as well as dry eye, eyelid swelling and injection of the conjunctival blood vessels making the eye seem reddish or pink. In addition though not mentioned in the product insert there are reports of Latisse® leading to darkening of the iris.

Although Latisse is a prescription only product it’s very easy to purchase this drug online without a prescription. The top of the Google search list for pilot case online is a site where you simply submit a medical form history and a “patient marks licensed physician will carefully ensure Latisse is a safe  option free you to use before we send your order.” They even advertise a discount for Valentine’s Day few by two more bottles. The retail price@drugstore.com for one bottle for peace is $115.99, but several online sources appear to be selling Latisse for between $70 and $85 per bottle. A bottle will last one month if applied as directed to both upper lids and even the manufacturer notes that Latisse only works as long as you continue to use it. Whether longer thicker eyelashes are worth approximately hundred dollars a month plus the risk of serious side disorders that could even affect vision and cosmetic or annoying eyelid problems is for each individual to decide.

Resource: Latisse side effects

There are several interesting things about this recommendation. First the quadrivalent Gardasil vaccine is chosen over the alternative bivalent vaccine (Cervarix). The obvious reason for this is because the quadrivalent vaccine gives immunity against the type 6 and 11 HPV that cause up to 90% of genital warts. As a family physician and a parent of a male child this alone would be enough reason for me to immunize my son against HPV. Despite this significant benefit of the vaccine, most of the data considered in this decision-making was based on risk reduction of the more serious consequences of HPV 16 and 18 infection. These can include anal intraepithelial neoplasia, various epithelial head and neck cancers, and penile cancer.

The MMWR article discusses the burden of cancer disease in males related to HPV infection. The article states that of the approximately 22,000 HPV 16 and 18 associated cancers in the US each year approximately 7000 are in males. Many of these are oropharyngeal and anal cancers. The incidence of new cases of genital warts each year in the US among sexually active males is estimated at a quarter million.

The MMWR article also addresses the efficacy of the quadrivalent vaccine in inducing adequate immunity. The efficacy in inducing antibodies against all four strains of genital warts was almost 90% in one large study. The reduction in the incidence of genital developing warts in the population who received at least one dose of vaccine was estimated at 68%. A subset of men in this study group who were immunized who have sex with other men was looked at separately.  Their risk for developing anal epithelial neoplasia related to HPV 6 and 11 was reduced by approximately 50%. It seems reasonable to assume that the incidence of straight men getting this immunization will be less likely to carry the HPV 16-18 strains and put their female partners at risk for cervical dysplasia and cervical cancer.

Safety of HPV Vaccine for Boys: The safety data for the HPV for vaccine is very strong. The most common adverse events were mild or at most moderate, and were usually injection site swelling, with many fewer cases of headache and fever. Approximately 40,000,000 doses of HPC for vaccine have been used the United States in the first five years since licensure and no increase in incidence of any serious consequences have been noted. Don’t believe the ranting of fanatics who badmouth this along with many other safe and effective vaccines. Fainting after getting the shot seems to be the most serious adverse outcome and doesn’t seem to be any higher than with any other shot.

Cost of HPV Vaccine for Boys:  At approximately $130./ dose, and $390./ 3 shot series, this is a real concern. Probably the strongest argument against routine HPV for vaccine of males is its cost. Any discussion of the benefits of immunization of males depends greatly on the incidence of immunizations of females. The rate of immunization of females in the US remains much lower than ideal with an estimated 47% of females age 13 through 17 having received at least one dose and only 32% having received all three doses. If a very high percent of females was immunized the risk of males who have female sexual partners acquiring genital warts would be considerably lower. Given the high current prevalence of the HPV virus it seems reasonable to assume that for some time now heterosexual young men will continue to have a significant chance of acquiring HPV virus. The estimates of the cost of per quality adjusted your of life in men vary from $20,000 to under $50,000 based on varying assumptions but unquestionably the cost of HPV vaccination of young men routinely is going to be high.

Why Give HPV Vaccine for Boys So Young?: Parents may ask why immunize my 11-12-year-old boy who I’m quite certain is ingrained have sex for many years. The answer is several fold. The first is that the highest efficacy for prevention of genital warts is in pre-sexual persons. The second is that children immunized between ages nine and 15 had higher antibody titers and therefore presumably better immunity than those vaccinated from age 16 through 26. The bottom line is that boys vaccinated prior to first sexual contact and purred age 15 have the best chance of immunity to genital warts and avoiding contracting them.

So what should you do for your boy?  My recommendation is that you get your son immunized a relatively young age, certainly before age 15 but ideally with his pre-sixth-grade immunizations around age 12. Why so early? Why not is really the better question. The immunity seems to be long-lasting and getting the vaccine for your child while you still have considerable influence over their receiving the vaccine, while you’re still confident that their pre-sexual, and while they’re in the routine of getting other immunizations just seems to make the most sense to me. So is HPV for boys a good choice? My  recommendation:  A strong yes.

Leave a comment and join the discussion.

Oxycontin has a reputation as probably the most abused of the prescription opioids because of its lack of acetaminophen, its high percentage of rapid release oxycodone, and its lack of properties preventing crushing the pills which eliminates the extended release properties and makes it possible to inhale, inject or smoke the drug.  Sometimes known as Hillbilly Heroin, Oxycontin is among the leading causes of prescription drug overdose deaths and opioid addiction in the U.S.

If Zohydro receives FDA approval as a single ingredient, high dose hydrocodone product there is little doubt that it will join Oxycontin as a major drug of abuse.  Proponents of non-acetaminophen opioid pain medications are correct when they state that acetaminophen has its own problems, and especially when too many pain pills are taken to get pain relief the daily acetaminophen dosage can exceed the 4000 mg / day maximum safe dose.  Serious and even fatal acetaminophen liver damage can result.  Still single ingredient opioid products are so prone to diversion, addiction, and abuse that I anticipate that Zohydro, if approved, will quickly become a major drug of abuse.

One thing physicians have on our side now is the Oxycontin experience.  We will be much more skeptical of allowing escalating Zohydro doseage and addiction become commonplace. Still I am not looking forward to one more drug with few advantages and much abuse potential coming to market.

Oxycontin is available in doses of 10, 15, 20,30, 40, 60 and 80 mg tablets.  Using the recommended opioid Morphine Equivalent Dosage calculator available for download at the Agency Medical Directors site, 30 mg of morphine is equivalent to 30 mg of hydrocodone but to only 20 mg of oxycodone (i.e. oxycodone is 1.5 x as potent on a mg for mg basis than hydrocodone).  Using these equivalency ratios it would be expected that Zohydro might become available in doses up to 120 mg per pill.  This would make it highly popular as a drug of abuse, as current hydrocodone products all contain acetaminophen, and maximum hydrocodone dosing even with products with 10 mg hydrocodone and 325 mg acetaminophen are 12 tablets daily, making 120 mg of hydrocodone the maximum daily hydrocodone dosage.

For related articles see:

Oxycontin vs. Oxycodone

How to Spot a Drug Seeking Patient

Oxycontin: What’s The Big Deal

Leave a comment and join the discussion.  Subscribe using the right sidebar e-mail subscription form or follow @DoctorPullen on Twitter.

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.

When I see a patient with a typical fatty lump I’m confident is a lipoma, or a firm well circumscribed dermal level skin lesion I’m certain is a dermatofibroma, the level of uncertainty is very low.  In these cases I feel very good about telling my patients their diagnosis and that no further diagnostic evaluation is needed, with the proviso that if the behavior of the lesion changes to let me look at it again.  Certainly we could have a higher level of certainty if I excised all of these lesions and sent them for microscopic pathology evaluation, but the known risks of this option, i.e. scarring, pain, cost and risk of complications seem to clearly outweigh accepting a very low degree of uncertainty. This same balancing act plays out with nearly every office visit.  Is the chest pain cardiac, reflux esophagitis or chest wall musculoskeletal pain? Is the headache a tension headache or something more serious like an aneurysm or a brain tumor?  Making decisions about when to live with some level of uncertainty is the real decision.

Just today I was struck with the flip side of uncertainty.  The beauty of our human existence is by its very nature filled with uncertainty.  We all certainly will die, but when, how, and where are all uncertain.  The exact prognosis for most disease processes is quite uncertain. My wife has ovarian cancer, and although she has accepted chemotherapy exceptionally well, has had very limited complications of the initial course of therapy and the second course after her first relapse, she is now in a time of waiting to decide when to treat the gradually increasing tumor marker that haunts us and tells us the cancer is not gone, it’s just lurking and trying to come back.  After an all-too-brief three month hiatus of no CA-125 testing we anticipated a fairly high number, and were pleased yesterday  when the marker came back only modestly higher than prior to the level three months ago.  This was a reminder that nothing about this cancer is certain.  The long term prognosis is poor, but what does that mean?  Nothing is certain.  Kay may live many months or even a year or two (or more?) before needing more treatment.  The next treatment, whatever that turns out to be may be highly effective, totally ineffective, or anywhere in between.  A poor prognosis maybe, but the uncertainty in times like this gives room for hope. Will a breakthrough in ovarian cancer happen in time for us?  More uncertainty.

For some patients living with uncertainty is difficult, anxiety provoking, and hard to accept.  In our situation I give thanks for the uncertainty.  It is far easier to remain upbeat, positive and hopeful when a future that could be looked upon as filled with negatives has some uncertainty.

When you really think about life nearly everything is uncertain.  As a Christian I feel confident  that salvation is a certainty, but that is faith based.  When I look at objective expectations nearly everything has some degree of uncertainty.  Uncertainty is so much a part of our lives that we take great care to plan for the uncertainty.  Insurance, be it health insurance, homeowner’s insurance, life insurance or auto insurance we are paying for insurance against uncertainty.  Actuaries mathematically calculate the premiums of our insurance based on multiple sets of data and assumptions, but all of their calculations come with calculated degrees of confidence. On each of our medical study conclusions you will see a p-value.  The lower the p-value the less likely the conclusion is wrong by random chance.  You will never see a p-value of zero.

So this Thanksgiving I am giving thanks to my God for the uncertainties our lives. May we come to cherish this uncertainty, live each day and each minute with the certainty that there is some uncertainty about what the next minute, hour, day, week …  will bring.  May I continue to strive to achieve the optimal achievable levels of uncertainty in my management of my patient’s health care decisions, and may the uncertainties in my own and my family’s lives be a blessing so that we live each minute with only the certainty that we have the this minute to enjoy and cherish.

Another article you may enjoy is Citalopram HBr: Don’t Be Confused by the Name on the Bottle.

Don’t miss a post.  Subscribe using the right sidebar feature.

You may also enjoy:

Actual Causes of Death in the U.S.: Not What You’d Think

Leading Preventable Cause of Death in America

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 

You may also enjoy:

Overdiagnosis

We still commonly use a relatively few medications with a narrow therapeutic window, notably warfarin, digoxin, and lithium, but many others have fallen out of favor because safer effective treatments have become available. For fun and historical perspective let’s look at some of the drugs with troublesomely narrow therapeutic windows.

Thoephylline:  Prior to the widespread use of inhaled corticosteroids, long acting inhaled beta agonists, more aggressive use of short burst courses of oral corticosteroids, and new medications like spireva, Singular, and others the mainstay of asthma and COPD management was theophylline. With a non-linear metabolism (the serum levels do not gradually and steadily increase with increased dose, but rather jump quickly at times with minor dose changes), severe toxic side effects at only slightly supra-therapeutic serum levels, and many drug interactions, theophylline toxicity was a common cause of ICU admission for many years.

Digoxin:  Digoxin is still used for many patients, but not nearly as often, and usually at considerably lower doses than when it was considered a key part of management of most patients with CHF and tachyarrythmias of many types. We have learned a great deal about CHF treatment in the last 20 years, and digoxin plays at most an ancillary role in cardiology today for most heart conditions. This is nice as often life threatening arrhythmias were commonplace in years past, and digoxin toxicity was extremely common.

Tricyclic Antidepressants: These are a prefect example of a narrow therapeutic window. At a daily dose of 300 mg daily, amitripylene ingestion of as little as 4-5 days of dosing could be lethal. In contrast ingestion of a full month prescription of most SSRIs is unlikely to be life-threatening. Amitriptylene, imipramine, nortriptylene, desipramine and later some tetracyclics like trazodone were the only effective antidepressants available prior to Prozac, and the SSRIs have been popular not just because of their lack of bothersome side effects. The fact that lethal overdose of an SSRI is extremely uncommon, whereas ICU admissions and deaths from tricyclic intentional and unintentional overdose were daily occurrences 30 years ago. We rarely use the tricyclic antidepressants in doses needed for depression today.

Warfarin:  We still use warfarin plenty, but new directly acting drugs like Pradaxa, Xarelto and apixaban are becoming available for prevention of stroke in atrial fibrillation, and are likely to be used in the future for DVT therapy. It remains to be seen whether bleeding complications will be significantly less problematic, but it is clear that the therapeutic window with warfarin is about as narrow as they get. A patient therapeutic on 5 mg daily, may be significantly over-anticoagulated at a dose of 6 mg daily, and with many drug interactions, dietary variation of vitamin K ingestion, and patient compliance issues with frequent INR monitoring this is a major factor in patient care.

Aminoglycoside antibiotics:  These remain a very effective therapy for many gram negative bacterial infections, but have in large part been replaced with much less toxic drugs. Use of these antibiotics requires close monitoring of serum levels and renal function to assure both therapeutic serum levels and non-toxic levels.

Lithium:  Lithium remains an effective therapy for the mania associated with bipolar disorder, but the narrow therapeutic window where serum levels below 0.5 usually not effective, but levels much above 1.0 leading to toxicity, drugs with a much wider therapeutic window are often preferred by patients and physicians alike. (Visit this Lithium side effects resource)

Aspirin:  No not 81-325 mg daily for their anti-platelet effect, but three Ecotrin or Bufferin 325 mg tablets four times daily. Prior to the huge list of NSAIDs beginning with ibuprofen and naproxen, high dose aspirin was the standard of therapy for rheumatoid arthritis, osteoarthritis and most inflammatory disorders.  Who remembers checking salicylate levels, watching for tinnitis and bleeding ulcers or hemorrhagic gastritis from aspirin toxicity.  I don’t miss those days.

Other drugs like many of our chemotherapy agents still remain in widespread use despite the need to push dosing to levels where toxicity is expected, but overall the development of safer and improved drugs has made consideration of the therapeutic window much less of a day-to-day concern than it was just a couple of decades ago.

Please leave your stories about use of drugs with narrow therapeutic window issues for readers to enjoy. Leave your e-mail in the subscribe area on the right side bar to be notified of future DrPullen.com posts, and follow on Twitter @DoctorPullen to get additional thoughts and health care commentary.

• Discount Drug Coupons: In every state except Massachusetts the use of manufacturer coupons to reduce the copay for brand name drugs is legal. Federal insurance plans Medicare and Medicaid disallow these coupons, as their real effect is to negate the intent of the payer (the U.S. government and its taxpayers in the case of Medicare and Medicaid) to force the individual patient to pay a premium in the form of higher copayments in order to use higher price brand name drugs. The effect is to give incentive to patients to use cheaper generics, save money themselves and save money for the health care system. Discount drug coupons take the incentive away from the individual patient and end up raising the cost of health care. Pfizer hopes that physicians and patients will make use of these coupons and help them retain market share instead of using less expensive generic atorvastatin.
• Making deals with the pharmacy benefits managers that insurance companies use to give rebates or market share incentive deals that in essence give larger profits to these companies if patients use Lipitor instead of generic atorvastatin. These pharmacy benefits managers have considerable power in the choices patients have and drugs they are dispensed.

If Pfizer is successful in their attempts to retain significant market share of the $11 billion in annual sales of Lipitor, the #1 grossing U.S. drug for the last several years we can be sure other pharmaceutical companies will follow suit as their drugs lose their patent. Don’t be fooled by drug discount coupons. They may save you dollars in select situations where an expensive drug is clearly the best alternative, but in my opinion are rarely good choices, and certainly not in the case where their sole purpose is to convince us to use a more expensive brand name of a drug where a generic alternative is available. Everyone wants to reign in the cost of medical care, and discount drug coupons are trying to circumvent incentives to lower the cost of health care.

I’d be in support of either the federal government or each of the states following the MA lead and make drug discount coupons illegal.

This is both exciting and frightening. It raises huge questions including who if anyone should get this testing. Here is a list of some of the issues that come to my mind as we start the process of figuring out the role of this new technology:

1. Increased Abortions and Earlier Abortions of Down’s Syndrome Pregnancies:  One consequence of a more accurate test for Down ’s syndrome if it leads to more widespread testing or women for this condition is that more women will face the decision of abortion or not.  Now women first face the question, “Would I abort my pregnancy if I knew I had Down’s syndrome, and if so am I willing to undergo a test that could cause miscarriage to get that information.”  With the Sequenom™  MaterniT21™  test women will be able to get much more definitive information without a test that puts their fetus at risk from the test itself. This may lead to more women choosing to be tested. Putting aside the whole “pro-life vs. pro-choice” debate, the opportunity for earlier diagnosis will make technically easier and less physically traumatic abortions possible in women who have a Down’s Syndrome pregnancy.
2. Who should be Eligible for the Test?:  Although the risk of Down ’s syndrome rises with increasing maternal age many Down’s Syndrome babies have young Moms.  With a more accurate and less dangerous test available should all or more women be offered the test?
3. Who should pay for the testing?: This is a very complicated question.  This test is not going to be inexpensive.  On the Sequenom™  press release they suggest that the cost will approximate the cost of amniocentesis testing.  They do not make it clear if this means the cost of the amniocentesis test itself, the cost of the genetic testing of the cells obtained, or both.  If the test is done it will lead to higher costs for prenatal care as the test itself will significantly increase the overall cost of prenatal care.  On the other hand the cost of having a Down ’s syndrome baby is not inconsequential.  Down ’s syndrome children sometimes have major other congenital deformities, and the long term cost of education, support as adults, and associated family and societal costs are real and significant. A comprehensive cost-benefit analysis of this process will be interesting to see when it becomes available. These issues themselves will lead to ethical and moral choices.
4. Lower Incidence of Down’s Syndrome:  If this tests becomes widely used, and if more women choose to abort pregnancies with Down’s Syndrome fetuses, the incidence of Down’s Syndrome could significantly decline.  While many may consider this the desired outcome, some Down’s Syndrome supporters fear that this may lead to reduced support and reduced research into drugs and other techniques to help Down’s children.

I’m sure I’ve only touched the surface of the ethical, emotional, medical, moral and financial issues this new MaterniT21™ test from Sequenom™ and likely others to follow will bring.  It seems a near certainty that with the ability to sample fetal cells from maternal blood other genetic tests like tests for cystic fibrosis, sickle cell disease, and many others will follow.

Don’t miss a post, subscribe using the email subscription in the right sidebar.

You may also enjoy:

When No Immediate Treatment is the Best Option for Prostate Cancer

Prayer Saying Goodbye Mom

In the nearly 30 years I’ve been practicing medicine there has been one miracle vitamin/mineral/supplement after another in vogue, and almost none of them have stood the test of time.  The only way to get the full benefit of nutritious foods is to eat them.  Bummer.  It’s so much easier to just buy vitamins or supplements and eat junk. Sorry but that just doesn’t give the benefits of a nutritious diet.

In the last couple of weeks two new studies show that there may be more harm that good from taking several vitamins.  A large study published in the Archives of Internal Medicine where 38,000 women were followed for 17 years showed slightly higher death rates in women taking multiple vitamins than in  women not taking them.  Specifically taking multiple vitamins, vitamin B6, iron, copper, zinc and magnesium were all associated with statistically significantly higher death rates.  Only calcium seemed to be associated with slightly lower death rates in this study of older women.

An NIH study released recently showed that Vitamin E is associated with higher rates of prostate cancer.  Over the years Vitamin C, Vitamin E, beta carotene, saw palmetto, multiple antioxidant regimens, and nearly every vitamin with a letter or number has been in fashion for reduction of one health condition or another. One by one they have almost all been shown to be useless or worse.

Who else remembers the theory that the whole trick to avoiding atherosclerosis was to ingest the right ratio of saturated to polyunsaturated oils.  I remember a resident physician in Boston when I was a student who urged everyone to drink corn oil every day so that we could eat all the meat we want because our ratios of fat consumption would be in balance and that would make eating animal fat OK.  Most of us laughed at him, but that theory had lots of followers 30 years ago.  Beta carotene and vitamin E as antioxidants have been clearly shown to be more harmful than good.

So what’s a person to do? Here are my suggestions:

1. First and most important try to eat a healthy diet.  Avoid fad diets, eat more fruits and vegetables, less meat, and exercise more.  Don’t think you can rely on vitamins, mineral supplements, or gimmicks to substitute for healthy eating. See previous posts on   Anti-inflammatory Foods,  Foods High in Fiber , and Anti-aging Diet.
2. Be skeptical of whatever vitamin or supplement craze is in fashion at any given time.
3. Don’t think that more is better regarding vitamins.  It has long been known that high doses of vitamins A, E and B6 can be toxic.  There is little evidence to support high doses of any of the other vitamins either.
4. Keep in mind special conditions where supplementation with specific vitamins is important.  Examples of these include many causes of malabsorption like gastric bypass surgery, some medication use, and celiac disease.
5. Understand that this is a long term issue.  Eating well this month is good, but eating well for a lifetime is the key.
6. Avoid vitamin regimens that have been clearly shown to do more harm than good.  These would include:
   1. Beta-carotene supplements
   2. Vitamin E supplements in most people
   3. Iron supplements in men and post menopausal women
   4. High dose supplements with nearly every vitamin.  Currently Vitamin D is in vogue, and currently most of the data looks positive.  Time will tell whether this works out or not.
   5. I’d avoid even a multiple vitamin daily at this time if you eat a reasonably healthy diet and have no specific reasons to take the vitamin.

For other related articles check out:

Psyllium Husk

Dr Pullen Lives the Mediterranean Diet

Healthy Fruits – Healthy Vegetables 

Use the subscribe section on the right sidebar to get e-mail notification of each new post, and follow @DoctorPullen on Twitter to see both DrPullen.com posts and other thoughts and information I find interesting.

By a physician’s  balanced perspective I mean the ability to look at the whole clinical, personal and psychological situation in which a medical decision is being made and help their patient make choices that are aligned with both the medical facts and reality as well as the their own beliefs, values and desires. Often the emotional issues or prior anecdotal experiences of a patient can prevent them from keeping perspective in making important decisions.  My role at times is to help them see the broader picture and make the best decisions.

Sometimes this is simple, but sometimes not simple at all.  Let’s look at one simple and one complex example, and then summarize by looking at examples of times keeping perspective helps with making the best choices.

Simple:  A 45 year old male with a blood pressure of 195/125 who has no symptoms but is a smoker, has a poor lipid profile and whose Dad had coronary bypass surgery at age 50 is reluctant to take blood pressure medication because he “just hates to take pills.”  The physician has a simple task.  Find out the real reasons for being reluctant to take medication, present the facts- this fellow has a >30% chance of a coronary event in the next 10 years, and find a way to convince him to use medications to control his blood pressure. In this case the evidence that treatment of this patient’s hypertension along with his cholesterol can reduce his risk of an event to 11% (if systolic BP goal of <130 and Total cholesterol goal of <180 are met, and if he can quit smoking to about 3%).  Presenting this evidence to the patient, along with finding out the reasons for disliking taking medications is likely to persuade him to comply with therapy, and be hugely to his benefit.

Complicated:  A 39 year old mother of two who is divorced but involved in a new relationship with a childless man is found to have an enlarged uterus on routine annual exam.  Ultrasound shows a thickened endometrial lining at 1.7 cm, and endometrial biopsy shows endometrial hyperplasia with atypia.  Her family physician refers her to a gynecologist for further evaluation, and she is presented with several options.  She can have a laparoscopic assisted vaginal hysterectomy to remove the uterus and assure no progression to endometrial cancer.  She can have a D&C, which will further assess the endometrial pathology and likely but not absolutely get rid of the atypical cells.  She can take hormonal medications to get a “medical D&C” to bring on a heavy menses and try to rid her uterus of the hyperplastic  lining.  Keeping perspective of her wishes, future plans and feelings about the options is very important in helping this woman make the best decision for her individual situation.

In the former situation with family doctor trying to convince the patient to treat their hypertension is straight forward.  Hopefully the physician can help the patient in keeping perspective of the whole picture and will lead the patient to comply and take the drugs to reduce their risk of serious long and short term cardiovascular problems.  In the latter case the physician will hopefully discuss the needs of the woman involved and help her in keeping perspective of both the medical facts and risks as well as her feelings and needs in making her choice.  Does she want further children? How does she feel about a hysterectomy?  Is she willing to submit to long term careful follow up of the condition if she chooses a less aggressive therapy?  Keeping perspective involves figuring out the needs of the patient involved.

Examples of when keeping perspective in mind rises to the top of the physician roles include:

• prostate cancer treatment, especially in the older man
• treatment of moderately elevated LDL cholesterol
• whether to take estrogen for moderately severe hot flashes and night sweats around the time of menopause
• whether to use oral contraceptives, an IUD, or barrier contraception at various times of your life
• whether to take Accutane for moderately severe acne
• whether to start insulin for poorly controlled type 2 diabetes

The list could take up pages, as it really comes up to some degree with every physician visit.  Sometimes the issues are so simple as to be obvious to both the patient and the physician, and go almost without overt comment.  Other times as the physician we can help by labeling our role as helping the patient at keeping perspective, and assisting in their decision making by adding our perspective while trying to understand theirs.

You may also enj0y reading:

Which Arguement Shoots Down Your Excuse for Not Getting a Flu Shot or

USPSTF:  Losing its Independence?

You can subscribe to DrPullen.com using the e-mail sign up in the right hand column.  Thanks.

I Got Mine

This topic comes to mind again this year as we have plenty of influenza vaccine, on time this year and ready for distribution.  A prior version of this post was posted in 2010.  I have strong enough feelings on the subject to repost an updated version.  If anything good came of the Swine Flu epidemic on 2009 it was that more Americans get immunized not than ever before.

This year as every previous year Dr. Pullen was first in line at our office for my influenza vaccination.  I take seriously the mantra primum non nocere, first do no harm. It’s hard to imagine doing more harm than seeing a patient with influenza on Monday, and on Wednesday, the day before I get sick, sneezing and passing the influenza germ to one of my vulnerable older patients, or a pregnant woman, or a young baby who then dies from influenza.  This scenario is just inexcusable given that I could have avoided harming the patient if I had received the recommended and easily available influenza vaccination. It would be immoral and irresponsible to put my patients at that type of risk unnecessarily.  I encourage, coax, tease, and everything short of intimidate my employees and fellow physicians to get their influenza vaccination also.  School teachers, emergency workers, and others in close contact with the public should similarly feel morally compelled to get influenza vaccination. It is our moral responsibility.

I also got a Tdap vaccination last year also, even though was several years until I was due a tetanus shot.  See Dr. Pullen Gets His Tetanus Booster  Shot Years Early!  My thinking was the same, try to avoid a pertussis infection, and not put my patients at risk.

It’s a small step from discussing health care workers and influenza and pertussis vaccination, to talking about parents and childhood vaccinations.  The parent who chooses not to vaccinate their children against measles and pertussis puts not only their own child, but other children in the community and the school who may be at particular risk for complications from these infections in danger.  These children at high risk may catch these infections from these unimmunized children.  As a parent I’d feel terrible if my child died or became brain injured from measles, but I’d also feel horrible if my child passed Pertussis or measles on to a child with leukemia, or HIV because I chose to not immunize my child.  I appreciate that this is a free society, and we can make our own personal choices about health care including immunizations. It’s not illegal to decline recommended immunizations, but in many cases it is irresponsible and not living up to our community moral responsibility. Parents who choose not to immunize their children and take advantage of the herd immunity of the majority of children whose parents responsibly immunize their kids are just ignorantly selfish.  They think they are protecting their children from risks of immunizations, though a great mass of evidence refutes this point of view.  In fact they are putting both their own child, and other children who lack immunity through no choice of their own or their parents at risk.

I’m anticipating a rash of angry comments calling me a mouthpiece of the brainwashed physicians of organized medicine.  Don’t believe them.

See these references on the safety of childhood immunizations.

Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism  (there is none).

Data Fail to Support Thimerosal-Autism Link

The end of the autism/vaccine debate?

Book Is Rallying Resistance to the Antivaccine Crusade

Also see the great video at the top of the Musical Docs page Immunize: The Vaccine Anthem.

You may also enjoy:

Dr. Pullen Got His Tetanus Booster Years Early! 

Polio Eradication 

Subscribe to DrPullen.com using the email sign up in the column at the right.

Can Cancer Ever Be Ignored?  by Shannon Brownlee and Jeannie Lenzer

I especially like the article’s visual.  It raises the seldom stated but often considered axiom that every good primary physician knows:  If you don’t want to know the answer, don’t ask the question.

Dr. Kenny Lin, a key player in the PSA debate as the ex-USPSTF point investigator on the PSA screening dilema who resigned in protest of political pressure to withhold new recommendations to make PSA screening a grade D (as in don’t do it) for PSA screening in healthy males that was based on the best available evidence but was politically unacceptable writes another excellent discussion of the topic:

The Meeting that Wasn’t Revisited by Kenny Lin MD.

Stay tuned for the latest on this controversy.  Subscribe to DrPullen.com to not miss a post.  You can choose to subscribe to all posts, or just by category.  Just enter your e-mail address in the subscribe area at the right.

NOTE THAT SINCE THIS WAS POSTED THE USPSTF HAS POSTED A PROPOSED UPDATE TO THEIR RECOMMENDATIONS FOR PSA TESTING FOR MED AS A “D” RECOMMENDATION, i.e. RECOMMENDING AGAINST USE OF PSA AS A PROSTATE CANCER SCREENING TOOL.

by Patrick Maguire, MD 

As we near the end of Prostate Cancer Awareness Month this September, hopefully many of us have learned a thing or two that we didn’t know about the disease in August. Just last week, a major study of predictors of sexual function after prostate cancer treatment was published in the prestigious Journal of the American Medical Association (JAMA). I found some important info in the paper and recommend it highly to men who are considering their options for treatment. The link for the full document is:  http://jama.ama-assn.org/content/306/11/1205.full.pdf. An in-depth discussion of the topic can be found at on my blog The Cancer MD. As opposed to various treatment choices, one option for men after a prostate cancer diagnosis that we don’t hear too much about in theU.S. is active surveillance.

Many terms have been used to describe what is now most often called active surveillance. These include: watchful waiting, close observation, and expectant management, among others. Given the right circumstances, the option of avoiding prostate cancer treatment altogether is often best. Which men are candidates for watchful waiting after their diagnosis?

To be sure, prostate cancer is a spectrum of disease that can range from indolent to extremely aggressive. Men with low-risk prostate cancer may be good candidates for no immediate treatment. These cancers can’t be felt or are only felt in part of one side (lobe) of the prostate, produce a low level of prostate specific antigen (PSA) in the blood, and appear not too aggressive under the microscope (Gleason score of <7). Among this group, younger, healthier men are usually the best served by treatment.

Men with low-risk disease who are either older or in poor overall condition should strongly consider expectant management. In general, it takes more than a decade for early prostate cancer to spread to other sites in the body (metastasize) and ultimately kill a man. Therefore, men who have a life expectancy less than 10-15 years should think long and hard about the option of no treatment. In medical school, we docs agree to abide by the Hippocratic Oath, a major principal of which is “primum non nocere” (do no harm). We don’t want to put a man at risk for possible side effects of treatment, unless we have reason to believe that the treatment has a good chance to improve survival or quality of life.

So, if you or your loved one has been diagnosed with prostate cancer that’s found very early, ask your urologist or radiation oncologist whether active surveillance or watchful waiting is a reasonable option. Sometimes, though it may feel strange, you might have to tell him or her, “Doc, don’t just do something. Stand there!?

Dr. Maguire regularly posts on TheCancerMD.com and is the author of a book that I have enjoyed reading that helps laypersons understand the language, facts and treatment options for the most common cancers. When Cancer Hits Home: Cancer Treatment and Prevention Options for Breast, Colon, Lung, Prostate & Other Common Types. 

At the crux of these comments is that the required elements of this wellness exam bear little resemblance to what most patients would consider a physical exam.   CMS intentionally made up brand new CPT codes for these exams so that they are not considered the same service as a preventative care “physical exam” code for an adult patient.  Those cynics among us suspect that the primary reason for this was financial. Medicare did not want to use the age adjusted RVU payment multiplier for this newly authorized service.  In order to justify a mush lower payment amount they simply defined a new service as a Medicare Wellness Exam.  The RVU for a preventative service code is considerably higher than the code for a routine office visit, so Medicare conveniently chose to reimburse the Medicare Wellness Exam at the level of a routine office visit, not as at physical exam level.  That when combined with the fact that Medicare uses a compensation scale per RVU that is considerably lower than all commercial insurers make doing a Medicare wellness exam for an elderly patient pay considerably less than a typical office visit for younger insured patient with modestly complex medical problems.

Given that a family physician who wants to stay in business cannot spend twice the time of a regular office visit on a Medicare Wellness Exam that pays considerably less, the required elements of the Medicare Wellness Exam visit consume much of the time a reasonable physician can allot for the visit.

Making this all the more complicated for patients is that Medicare patients in my practice for years have become used to not being able to have a wellness visit, and so I have tried to provide these services broken into pieces at the time of disease management visits.  This rather sudden change has left patients wondering what I’m doing spending my time at a wellness exam discussing things that may seem silly to them, or may not be what they perceive as having much to do with wellness.  Most patients coming in for a wellness exam reasonably expect this to include a medical history, a medical exam and addressing preventative services due as well as at least documenting and formulating a plan for future evaluation of any concerns they bring up at the visit.  This seems reasonable, except that the Medicare proscribed wellness exam has to include an assessment of:

• Patient fall risk
• Depression screening
• Addressing their end of live decision status
• Ability to accomplish a variety of needed daily tasks like managing money, shopping, housework, and transportation needs, and other activities of daily living.
• Vision assessment
• Hearing assessment
• Assessment of immunization status
• Assessment of other USPSTF category A & B preventative services due, including colon cancer screening, breast cancer screening, prostate cancer screening discussion, and diabetes screening.

The healthy, active and otherwise well 67 year old may think many of these queries re irrelevant, and they may in fact be irrelevant.  Some may even feel insulted that I’m asking about their risk of falling and managing their household when they want to talk about their risks of heart disease, diabetes, stroke and cancer.  The frail, near blind and near death 96 year old living with family may have difficulty with so many of these issues that to adequately cover even some of them would require more time than can be allotted to the entire exam.  Many of these patients may feel this visit should include a much more comprehensive hands-on physical exam than is realistic in the visit given the mandated topics to cover and the time reasonably expected for the level of compensation allowed.

Still other patients will expect their chronic health conditions, or various other complaints to be addressed at this visit.  Their shoulder hurts, their ankles swell, they have some constipation, and their back aches in bed at night.  It is difficult to tell the patient that this visit is only for the mandated Medicare Wellness Exam issues and not to address their multiple chronic health problems.  Yet other patients really don’t want a Medicare Wellness Exam at all, rather they want a problem focused visit but want to have the visit billed as a Medicare Wellness Exam because it is paid by Medicare without copayment or deductible payments by the patient.

It is simply not realistic to try to complete the mandated Medicare wellness exam points, do a history and physical exam in the traditional sense, and have time to even listen to other complaints.  To try to listen to and also address these complaints is even less likely.

I think Medicare is way off base in setting rigid and rigorous expectations for a wellness exam.  Allowing the patient and the physician to set an agenda that meets the patient’s needs and expectations would have been a much wiser approach. The concept of giving patients the opportunity to see their physician once annually to address their personal preventative care issues without making a laundry list of mandated issues to include in the visit could have been great.  As it is now the visit becomes a race to cover the mandated topics while trying to include at least some of the reasons the patient wants to be seen.  This is one more example of the Medicare rule-makers just trying too hard standardize care and mandate excellence, with the unintended consequences of forcing every American over age 65 and on Medicare to be subjected to essentially the same one-size-fits-all Medicare Wellness Exam.

What is Hospice?

Hospice is not a death sentence. It is an opportunity to live life to the fullest until you die.

I have been a Hospice volunteer since 1994. It is my passion. To be of service to others during such an important and intense time of life is an honor. The more I give, I am repaid tenfold. In order to qualify for Hospice a patient must be  diagnosed with a terminal illness that if it were to progress at the normal rate, would only have six months to live. To be eligible a patient can’t be involved in treatment to try cure the illness. Their doctor must write a referral for the patient to be evaluated for Hospice care.

Once enrolled, if the patient lives to the six month timeframe they can be evaluated and reinstated in the program. Hospice provides many services that assist both the patient and the family. I have had many conversations with family members and friends of terminally ill patients who were anxious because of unresolved issues with the patient or because they just felt they needed to share something and had not done so. I always encourage them to make time to talk about the issues. It will be too late once the patient has passed. If left unresolved these situations can lead to the survivor feeling regret, sadness, guilt or frustration. Grief is natural but adding the pressure of not talking openly before someone dies can make the grieving process much harder.

Many patients have talked with me about the importance of relationships in their life. They have never expressed regret about wishing they had more money, possessions or fame. It is so important to most people to know that they don’t have any unfinished business, which allows them to pass peacefully. Once a patient has been diagnosed with a terminal illness, Hospice is the best way to have their wishes met. The Hospice team; Nurse, CNA, Chaplain, Social Worker, Medical Director, Volunteer Coordinator and Volunteers work together to accomplish the patients desires. This team effort helps address the patient’s complete needs; physical comfort, emotional and spiritual support. Treating the entire patient is very important. Then, after the patient passes the family has a great support system and grief counseling, and support groups available anytime there is a need. I have had many heart-to-heart talks with patients in addition to fun and silly times together. After every assignment I take time to reflect on the experience. I have always learned something from each patient. The patients and families have always thanked me and said how much my service and the Hospice services in general made a positive difference.

I encourage anyone interested in Hospice or in volunteering to call your local Hospice organization. If you have questions please contact me at christinalufkin1@yahoo.com. Christina is also available for interviews or guest speaking engagements. Christina Lufkin, Author “Live with Purpose:Die with Dignity” www.christinalufkin.weebly.com

Comments by Dr. Pullen:  Over the years I have had nothing but positive experiences with hospice.   When my Mom passed last spring Hospice was involved and they definitely made for a better experience all around. See my post, Saying Goodbye.  Hospice has several major advantages from a flexibility and financial standpoint also for terminal patients.  The Medicare reimbursement for Hospice is on a per-diem basis, and the Hospice team has a great deal of flexibility in choosing services to provide to patients, many of which would not be eligible for regular Medicare coverage.

You may also enjoy How We Fail and End of Life Care.

Oral antibiotic therapy, topical antibiotic therapy and combination of oral and topical antibiotic therapy has long been used in the treatment of rosacea.  Rosacea is a very common and disconcerting facial skin condition.  It is estimated to affect up to 16% of women and 6% of men in its milder form, and 1-3% or people in the more severe pustular type.  Tetracycline antibiotics in particular have been popular in treatment of rosacea, and the inconvenience of use of tetracycline which needs to be taken on an empty stomach makes doxycycline more popular.  The typical antimicrobial dose of doxycycline is 100 mg twice daily, but for rosacea lower doses seem as effective.  Enter Oracea, a once daily 40 mg doxycycline dose, packaged as 30 mg of immediate release doxycycline combined with 10 mg that is released slowly to the intestinal tract to give longer low serum level concentrations of doxycycline.  The manufacturers claim that this formulation keeps the serum levels of doxycycline below the concentrations needed for antibacterial effects during all or almost all of the day, and can thereby avoid the common doxycycline side effects of yeast infections as well as the induction of antimicrobial resistance.  This sounds great, until you read find that the retail price of Oracea is $426.25 / 30 pills at Costco pharmacy vs. $60.51 / 100 pills of doxycyclie hyclate 20 mg, and $10.83 for 100 pills of doxycyline 50 mg.  This means that in return for making 10 mg of the once daily dose of doxycycline sustained release Galderma labs marks up the price 11.7x the price of generic twice daily doxycycline, and 65x the price of taking 1/4 of a 50 mg doxycycline tablet.  (not incidentally the cost of doxycycline 100 mg tabs is also $10.83/ 100 pills at Costco, the lowest price Costco gives on bottles of 100 pills of prescription).   You might assume that it was tremendously expensive for the makers of Oracea to do vast studies of Oracea to prove its efficacy.  Not likely as in the only placebo controlled studies I could find the total number of participants was 537 followed over 12 weeks.  In these studies Oracea was in fact found to be more effective that placebo, with about a 50% reduction in the “active lesion” counts noted.  Still in the first line of the study publication in the American Academy of Pediatrics the Background assumption was, “Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea.”  I can find no study comparing 20 mg twice daily or 25 mg twice daily of generic doxycycline with Oracea.

I’ve seen the graphs shown by the Galderma reps showing a lower percentage of a 24 hour period where their product remains below the antimicrobial serum levels, while once daily doxycycline 50 mg rises into the antimicrobial range for part of the day.  They jump to the conclusion that this will lead to more yeast infections and more antimicrobial resistance.  I could not find any evidence proof of this being the case.  Oracea claims an incidence of yeast infection of less than 1%, but has not compared the incidence of yeast infections with Oracea to generic doxycycline 20 mg twice daily.  Dentists suggest that the incidence in their patients at this dose is quite low too.  They also show not data to support their claim of lower antimicrobial resistance than alternative low dose doxycycline regimens.

Until Oracea has been shown in head-to-head studies to outperform low dose doxycycline immediate release once or twice daily, or has at least shows significantly lower incidence of doxycycline side effects than low dose immedicate release doxycycline I’ll just save my patients the expense of this ridiculously expensive reformulation of an old, well known and effective drug.  Don’t fall for the Drug Discount Coupons theory that if it doesn’t cost the patient out-of-pocket dollars it is inexpensive.  It’s still a real cost and one we can steer clear of at this point in time. It is estimated that oracea will bring in over $260 million in sales in 2011.  That is a quarter of a billion dollars we can avoid in holding health care costs in line.