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Category Archives: Opinion/Editorial

Asthenia

February 27, 2012 Dr. Pullen

Of the names we use to describe symptom in medicine the term asthenia is among the most descriptive. Somehow I am enamored by the term. Asthenia is an interesting word, beautiful in some way to me, but asthenia is not a symptom I look forward to using to describe my patient’s condition. Asthenia is almost a synonym for weakness, but implies a more serious connotation. Asthenia is usually used to describe a generalized weakness, as is noted in conditions like chronic wasting diseases like advanced HIV disease, cancer, advanced heart, kidney or liver disease, or some neuromuscular diseases. Asthenia is often associated with other symptoms like malaise, fatigue and dizziness. I usually think of asthenia being associated with weight loss, especially muscle mass loss.

Weakness that I don’t think of as being asthenia on the other hand is usually used to describe a loss of muscle strength that is localized or if generalized is not associated with overall wasting or other symptoms of advanced disease. Weakness can be associated with neuromuscular disease like a nerve root impingement, a stroke or other brain lesion and other causes that lead to true loss of power in one or more muscles, or can be more a perceived weakness where patients feel they need to exert more force than normal, but on testing muscle strength is normal. Disorders like chronic fatigue syndrome and depression can lead to perceived weakness

A specific disorder called myasthenia gravis is a condition where strength at rest is normal, but with repeated use muscle strength decreases. It is due to an autoimmune disorder where antibodies against the post-synaptic acetylcholine receptors at the neuromuscular junction are blocked.

Numerous medications have asthenia as a potential side effect. The HIV drug Ritonavir which functions as a protease inhibitor has been associated with asthenia. This has to be somewhat of a dilemma as progression of HIV itself is a potential cause of asthenia. Chronic opioid use for pain management has been linked to asthenia in some individuals. Alcoholism is a common cause of asthenia, as are other types of drug abuse. The list of potential medication causes of asthenia is long, and medication use always needs to be considered in a patient presenting with undiagnosed asthenia.

Still in my practice, admittedly a suburban practice where neglected disease is relatively uncommon and HIV is not a major part of my practice, advanced age, end stages of serious illnesses, and cancer are the most common causes of asthenia. As patients become very old it is common for them to lose strength and body mass and whether this is asthenia or not may be up for debate. Asthenia associated with weight loss is a fairly common presentation of undiagnosed cancer. Asthenia is fairly common with end stage cirrhosis and liver failure, with very severe congestive heart failure and with COPD as respiratory failure approaches. In most cases unless a diagnosis can be made with good treatment options asthenia is a serious if not ominous symptom.

I have to say I rarely describe a patient as having asthenia, but when I do it is with the intent of trying really hard to find an underlying cause that can be treated or at least discovered, because asthenia in my mind is usually something that needs to be figured out.

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Benign Neglect

February 23, 2012 Dr. Pullen

Benign neglect is a concept that comes into play more often than you might think in my office. As I mused about this over lunch today it led me to look at the genesis of the term, which I was surprised to find is attributed to Patrick Moynihan when he was in the Nixon white house. (I was most surprised to hear that this famously liberal democrat was in the Nixon white house, but he was in 4 consecutive administrations from JFK through Gerald Ford) The term was used to refer to a policy recommendation that the issue of race in the late 1960’s could benefit from a period of “benign neglect.”

I think of benign neglect in my office primarily in dealing with patients who are more likely to benefit from not investigating or treating a condition or complaint than by actively managing the condition. A good example is a woman in her mid 80’s with mild dementia and multiple chronic medical conditions, maybe longstanding diabetes and who has had a coronary bypass surgery 12 years ago who asks if she should have a mammogram. In this case her life expectancy is relatively short, maybe 2-5 years, and the benefit of an early diagnosis of breast cancer is minimal. In addition the diagnosis is going to force difficult decisions to be made. Is no treatment, minor treatment, or moderately aggressive treatment best for her situation? Is she competent to make the choice herself? The dilemma expands. Maybe the best approach is to not test for the condition in the first place. In her case most of the time it is an easy consensus to choose not to do the mammogram.

Benign neglect can also apply to situations where leaving relatively harmless conditions alone is better than aggressive treatment. Examples I see are molluscum contagiosum, where the lesions usually resolve with no therapy in a year or so vs. painful ablative therapy that is far from uniformly successful on the child with the lesions. Another example is with seborrheic keratoses ( the brownish waxy pasted on lesions so common on our skin as we age) or small lipomas (benign fatty tumors) of the skin. These generally don’t go away, and often very slowly grow, but usually never bother the patient except cosmetically. If the y need to be removed later it is not especially more difficult on larger lesions. If patients are comfortable ignoring these, then benign neglect is a great option. Benign neglect is a key to successful parenting too. It is more widely called ignoring, and involves not rising to the lure of a child’s minor misbehavior. Often the misbehavior is an attention gaining behavior, and ignoring the behavior will more likely lead to dissipation of it than confrontation or punishment. Examples in early childhood are temper tantrums, and in teens door slamming or a minor cursing. Bringing attention to the behavior may be just the attention the child consciously or subconsciously desired, and the benign neglect of ignoring can be effective at reducing the behavior.

It’s important to understand what you are doing when you choose benign neglect as the best tactic. It is not appropriate when it simply makes your life easier. In order to be truly benign the choice must in it total consequences have a neutral or better impact. Most of the time when I choose benign neglect I anticipate the likelihood of negative consequences of active intervention to outweigh the likelihood of negative consequences of choosing no active intervention. Benign neglect is an important part of good primary care, yet needs to be used consciously and carefully.

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Scope of Practice: Advantage of Seeing a Family Doctor First

February 20, 2012 Dr. Pullen

Early in my fourth year of med school, when I was trying to decide what type of residency to apply for, I realized that I enjoyed the breadth of the scope of practice a family physician embraces. I tell my patients that I specialize in what they walk through the door with. As a family physician I have to be comfortable and competent at seeing nearly any patient for any problem and helping them access the care that they need for the problem they present asking for help with. In addition I have to try to recognize problems or health risks that they may not recognize, and have to find a way to let my patients accept what I feel is appropriate preventative care and disease management. I need to be familiar with a vast array of medications, from psyllium to pradaxa, and problems from PSVT to psychogenic cough.

I often am asked by patients if they should come see me or if they should just go directly to the specialist they feel is going to be able to definitively address their concern. I don’t mean to sound pompous here, but often patients are way off base in choosing the specialist best suited to their problem. Seeing a specialist in an arena of healthcare different from your problem has several risks. These include significant delay in receiving appropriate care, incurring the expense of extensive testing in their area of interest prior to reaching the specialist appropriate to your circumstances, overdiagnosis, and missing related or unrelated problems that a family physician may recognize but a sub-specialist may not notice. Let’s go through these in more detail:

Delay in Receiving Appropriate Care: This can be the result of various causes. The one most concerning to me is when a patient makes a self-diagnosis and sees a specialist in that field. Often symptoms that seem related to one area expertise are caused by a disorder not apparent to the patient. Epigastric pain and nausea may be the result of heartburn and a gastroenterologist may be suited to evaluate and treat the pain. On the other hand it may be related to coronary ischemia and need urgent intervention. Seeing a gastroenterologist is not only not going to help, but may delay care, either because of a longer time to get an appointment for evaluation or because specialists often extensively evaluate issues in their area of concern prior to referral to another specialist. The time to have a trial of a medication for acid reflux and have an endoscopic exam of the esophagus and stomach may be detrimental to the care of a patient with coronary disease.
Incurring Expensive Testing: When a patient sees a family physician they are likely evaluated for the most serious or most likely problems causing their symptoms. The list of potential concerns often extends across several areas of sub-specialty interest. By looking at the most serious and most likely issues first a family physician is more likely to avoid expensive tests for very unlikely problems. An example might be a patient with groin pain. If this patient sees a family doctor, they will probably be evaluated by history and physical exam for things like inguinal hernia, urologic causes like kidney stone and infection, hip pathology, in women ovarian-gynecologic issues including ectopic pregnancy, gastrointestinal causes and neurologic causes. If they see a urologist they are likely to have extensive evaluation for urologic problems, and may get a correct diagnosis of a kidney stone or UTI. If their problem very likely a gynecologic problem, they are still likely to have extensive evaluation for the urologic issues because no specialist wants to miss a diagnosis in their field of expertise no matter how low the likelihood may be. This holds true for most specialists. If you see a sub-specialist you are very likely to have an extensive evaluation for problems in their scope of practice whether or not they think you likely have a problem in their realm. A family physician is more likely to go through a process of looking for problems they consider important and likely, and put off extensive evaluation for very unlikely diagnoses. The cost savings of the latter approach can be huge.
Overdiagnosis: I’ll be brief here, but if you have imaging like an MRI, CT scan, ultrasound or even many lab tests abnormalities are often noted that can lead to extensive testing which has its own risks, or diagnosis of a problem that does not now nor will ever bother you. The latter is called overdiagnosis. See a prior post on overdiagnosis for more information on this topic. Overdiagnosis may lead to medication side effects, risks of unnecessary procedures, and emotional distress.
Missing related or unrelated Problems: A specialist while highly trained in their scope of practice may not be focused on related or unrelated important health care issues. If you see a cardiologist it is unlikely that they are going to recognize that you are due for a mammogram and urge you to get a preventative care visit for this and other preventative services you are due. If you see a dermatologist it is unlikely you will bring up your “Oh doctor, by the way I am having these odd numbness and weakness symptoms,” that may lead your family physician to consider a TIA and make interventions to prevent stroke. The list of similar situations is nearly endless.

I feel pretty strongly that the first point of care for most health concerns should be either your family physician or the emergency department for life threatening emergencies. The scope of practice of your family physician gives you the best chance of efficient, timely and effective care.

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Meaningful (Ab)use

February 16, 2012 Dr. Pullen

January 1, 2012 brought another layer of documentation mandates to every office visit progress note. Meaningful use regulations added to chronic pain regulations in Washington have changed the context of many patient visits. As of Jan 1 of this year I feel like I’ve crossed over the edge and now have to spend more time as a clerk than as a physician interacting with my patients. I’ve succumbed to well-intended, government-imposed veiled threats and financial incentives, you could say fear mongering and bribery by our governments. This has led me to agree to yet more documentation in every visit to show that in the case of pain management that I am complying with many abuse prevention practices, and in the case of Medicare my use of an electronic medical record shows meaningful use. I guess this is as opposed to meaningless use.

In the meaningful use arena the problem is in how the regulators define meaningful use. At our office we have had an EMR since 1997, and take expend considerable effort to make very meaningful use of the information. We have a virtual disease management registry so that we can improve our efforts to assure our diabetic, hypertensive and hyperlipidemic patients stay on track to maintain good control of their health. We make attempts to get patients in for preventative care visits. We use printed prescriptions to reduce errors with hand written prescriptions. Unfortunately in order to demonstrate the government definition of meaningful use, and qualify for a financial reward for meaningful use from Medicare, I need to do some other things with the EMR. These involve taking time during patient visits to generate documents to pass out to patients at the end of the visit. To a bureaucrat these may seem important, and maybe they are, but to me they mean I have to spend 2-3 minutes of each visit assuring that the patient’s gets a printed medication list and problem list, and then typing a visit summary and directions to give the patient. This means that the note for the patient encounter has to be complete or nearly complete while they are in the exam room. On a busy day I in the past have chosen to complete these at the end of the half-day so that later patients do not need to wait as long for me to get to their visit. For some visits I agree that these are important. For other visits they are just extra work that either takes time away from direct patient – physician interaction or puts me behind in my schedule and late for the next appointment and every subsequent appointment that half day.

In the case of pain management I have done the mandatory 4 hours of additional education on the use of pain medications. That was the easy part. Now I need to document at each visit that I am abiding by the state regulations. The concept of these is right on target, but the details of the regulations is onerous. Now for every office visit with patients on chronic opioid pain management we need to use specific tools to assess the individual patient for depression, opioid abuse risk, degree of pain control, level of functionality and be sure that every 6 months we have a new 20 point pain medication agreement explained, signed and documented in the chart. After this if there is any time left we can actually assess the problem causing the pain and see if there is anything to do to help with that.

These new regulations are on top of the complicated set of rules for what we need to document in order to show to the insurance company that they should pay me and what I need to document to give our lawyers enough information to defend me if I am sued. Oh, I also want to make a note that serves to help me or anyone else provide good continuity of care.

If I sound cynical it is not accidental. I feel like the newest regulations have gone over the top, and now every day I spend more time documenting care than I do providing care. It’s silly, and I predict that these efforts will turn out to be counterproductive. Patient satisfaction and actual quality of care will be lower as a direct result of government regulations designed to improve quality of care. There you have it, my experiences from my first 6 weeks of daily work under the 2012 Washington state chronic pain management regulations and the Medicare meaningful use incentive program.

As president Reagan famously said, “The most terrifying nine words in the English language are: ‘I’m from the government and I’m here to help .’ ”

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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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Latisse: Are Longer Lashes Worth the Cost and Risks?

January 13, 2012 Dr. Pullen

I find the most interesting thing about Latisse® is how it came to be used for growing longer thicker eyelashes. Latisse follows a familiar story like other hair growth products in that it was an incidentally discovered side effect/benefit of the active ingredient in Latisse® while it was being used for another indication. Latisse® got its FDA approval in December 2008, and was brought to market after discovering that the active ingredient in Latisse® called bimatoprost which was used as an eye drop for glaucoma was incidentally noted to lead to longer thicker eyelashes. This quickly led to a medical diagnosis in order to give an indication for a new drug. The medical term, or if you prefer medical diagnosis, for shorter or thinner than desired eyelashes is hypotrichosis of the eyelashes. Latisse® follows the list of other drugs which were incidentally noted to cause hair growth, Rogaine makes use of minoxidil, a seldom used oral medication for refractory hypertension that was noted to cause undesired hair growth when taken orally. Propecia uses the active ingredient finasteride (brand name Proscar®), which is used to shrink the size of the prostate and allow men with benign prostatic hypertrophy to urinate more easily. It was found later slow male pattern baldness hair loss and is now commonly used for that purpose.

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

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HPV Vaccine for Boys Now Recommended

January 5, 2012 Dr. Pullen

HPV vaccine for boys age 11-12 is now recommended by the Advisory Committee on Immunization Practices according to an MMWR report last month. They specifically recommend the use of Gardasil, the quadrivalent HPV vaccine that targets the HPV strains that cause cancers as well as the strains that cause genital warts. They also recommended the vaccine for use in males age 13 through 21 who have not been previously vaccinated and suggested that males age 22 through 26 may be vaccinated. This is a significant departure from the prior recommendation guidance that the HPV vaccine may be given to it males age 9 through 26 but fell short of recommending its use in this population.

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.

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Zohydro: The Next Oxycodone is On the Way

January 3, 2012 Dr. Pullen

A single ingredient sustained release hydrocodone product to be called Zohydro is currently in phase 3 clinical trials by Zogenix, and if it gets FDA approval is likely to become the next Oxydontin as a drug of abuse and addiction potential. I watched a segment on the evening news this week about Zohydro, and it is certainly not going to come to market without fanfare. Experts on the newscast did a pretty fair job of outlining the concerns of Zohydro, the potential for abuse and the issues with high dose single ingredient opioid products. Opioid overdose is much more likely with drugs where a very high dose of the drug is contained in a single pill.

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.

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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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