In practice in WA since 1987 I’ve tried to obey the letter and spirit of the law requiring pre and post testing counseling for patients receiving HIV testing, and have grumbled that this state law pushed into place by the gay-rights lobby at a time when little effective treatment was available and serious concerns about confidentiality and discrimination were major concerns.  Now that highly effective treatment for HIV is available the advantages of early HIV diagnosis would seem to make any barriers to testing for HIV counterproductive. An easy to use, affordable, reasonably accurate HIV test is a big change to the current status-quo, where considerable emphasis is placed on protection of the patient via counseling regarding results, and places more value on more widespread testing, early diagnosis and opportunities for prevention of spread of HIV.

Tests have been available for years for use by individuals to obtain their own specimen and mail it away to a test facility for confidential testing without accessing a physician or medical care provider.  These have not been widely used.  If the home oral swab rapid test comes to market it is very likely to be much more widely used. I fully agree with the FDA advisory panel that the benefits of this test will outweigh its risks. Still we should not ignore the risks.  I see the benefits and risks as outlined below:

Benefits                                                                               Risks

More HIV positive patients identified                     Rare false positives may lead to poor decisions

Prevention of some cases of HIV                           Rare false negatives may lead to not getting blood test

Low financial barrier to HIV testing                       Some patients may not get appropriate test results counseling

Convenience of HIV testing                                   What unintended consequences to expect

I anticipate that in mass market use the false positive rate and the uninterpretable results rate will be higher than the extremely low rates in the test populations used in the initial studies, but even so I expect the use of a readily available home saliva HIV test will be one more step toward earlier diagnosis and slowing of the rate of spread of HIV in the U.S.

I read a very interesting article today in the New York Times wellness blog by Danielle Ofri M.D. where she reminisced about an article in the annals of internal medicine entitled Lemons for Obesity. Obviously this was not to be taken at face value.  I don’t think anyone would consider lemons as an alternative for the grapefruits promoted in the famous grapefruit that. No they are referring to the last several major weight loss drugs to going down in flames and comparing them to flawed products commonly referred to as lemons.

It was a surprise to me just hours later to see that today the FDA advisory panel 18-4 recommendation for the approval of a new medication for weight loss lorcaserin hydrochloride. Lorcaserin hydrochloride, to be marketed by Arena pharmaceuticals as Lorqess® is a drug with serotonergic properties reported to have anorectic benefits and lead to very modest weight loss. At first glance this sounds awfully like Meridia, a drug recently taken off US market because of cardiovascular side effects, in that the weight loss experienced by most patients taking it is quite modest. In the studies presented the FDA there was a 3.3% difference in the percentage of body weight decrease in patients taking locaserin hydrochloride when compared to placebo. The possibly good news that slightly more than 1/3 of patients taking lorcaserin hydrochloride lost 11% of their weight or approximately 25 pounds is somewhat promising.

The big controversy in the approval of lorcaserin hydrochloride appears to be that because it was initially presented the FDA for approval prior to their requirement that new weight loss drugs be thoroughly evaluated for valvular heart disease and other cardiovascular risks Arena pharmaceuticals was not required to present extensive cardiovascular safety data.

In 2010 the FDA rejected lorcaserin hydrochloride when first presented because of a variety of concerns over safety and the very modest claims to weight loss but apparently now with the presentation of additional safety data the FDA advisory committee has changed its position. It’s anticipated that in late June the FDA will present a final ruling on lorcaserin hydrochloride for approval or not.

There’s another drug that has a lot more buzz after 60 Minutes segment called Qnexa. Qnexa is a combination of currently FDA approved phentermine and the anticonvulsant topiramate. Phentermine is an amphetamine that is approved for short-term use but the FDA but is not infrequently prescribed for longer periods of time by some physicians and weight loss clinics. Phentermine gained fame as part of the infamous weight loss drug combination Fen/Phen. Fen/Phen led to huge class-action lawsuits when it became clear that it was associated with valvular heart disease and pulmonary hypertension. Since Fen/Phen many physicians have been much more cautious in jumping on the latest weight loss drugs.

I’m hopeful that both Qnexa and  Lorqess are found to be safe and effective weight loss drugs. UBC academic in America is a gigantic concern and we’re a long ways from understanding obesity and from having effective nonsurgical approaches to weight loss and many patients. You may recall a previous post outlining obesity is the Leading Preventable Cause of Death in America as well as Just How Fat are Americans. It’s not that I’m obsessed with obesity but every day in the office I see several patients where their real underlying health problem is obesity. They usually see me for diabetes, hypertension, osteoarthritis, lymphedema, or any number of other presenting complaints that they and I both understand that the real solution to their health concerns is weight loss. Unfortunately I simply have little to offer as an effective solution. Bariatric surgery is gaining traction as an effective approach for the morbidly obese, but the financial barriers to actually getting the surgery are insurmountable in most cases. In addition the very long term risks and benefits of their after surgery are still somewhat uncertain.

Lorcaserin hydrochloride or Qnexa may turn out to be safe and useful tools in our battle to treat obesity but despite the seriousness of obesity and its associated medical complications I anticipate waiting for some aftermarket safety data prior to prescribing these new drugs if they receive FDA approval.

1. West Virginia (18.4)                      >30%                               25% (tie for 8^th highest)
2. Tennessee (16.9)                          >30%                              25% (tie for 8^th highest)
3. Alabama (16.9)                             >30%                              25% (tie for 8^th highest)
4. Kentucky (16.5)                             30%                               29% (alone w/top rate)
5. Arkansas (16.4)                            >30%                              26% (6 way for 2^nd)
6. South Carolina (16.3)                     25%-29%                        24% (4-way tie for 12^th)
7. Mississippi (15.9)                            >30%                             26% (6-way tie for 2^nd)
8. Iowa (15.3)                                  25%-29%                        22% (3-way tie for 17^th)
9. Missouri (15)                                 >30%                              26% (6-way tie for 2^nd)

For reference there are nine states with 2009 rates of obesity > 30% of which 7 are here in the top 9 most medicated states. The national average rate of smoking is 21% and all 9 of the states with the highest rates of medication use are in the top 17 states for rates of smoking.

I cannot access the SDI data to see what the rates of obesity are in the states with the lowest incidence of obesity are  but here are some other health related statistics and their relationship to a relative lower obesity rate.

1)      Colorado is alone as the only state in the US with a 2009 rate of obesity at <20%.   Why doesn’t Colorado rank at the very top for the lowest for death rates in adults?  Possibly because of a smoking rate of 20% (tie for 28^th highest leaving it pretty good but with  a death rate of 709/100,00 (11^th best).

2)      The fifteen states with obesity rates from 20-25% (the best except for Colorado) are listed below in alphabetical order:

                                                      Death rate (rank)                             Smoking Rate (rank)

a)      Alaska                               742 (2oth)                           24% (Tie for 12^th highest)

b)      California                         660 (4^th)                                15% (50^th highest, i.e. 2^nd lowest)

c)       Connecticut                   691 (8^TH)                               18% (tie for 38^th highest)

d)      Hawaii                               590 (1^st)                                16% (49^th, i.e. 3^rd lowest)

e)      Idaho                                 723 (16^th)                             18% (tie for 38^th highest)

f)       Minnesota                        675 (5^th)                                17% (tie for 44^th highest)

g)      Montana                           786 (33^rd )                            20% (tie for 29^th highest)

h)      New Jersey                     717 (14^th)                             18% (tie for 38^th highest)

i)        New York                        676 (6^th)                                19% (tie for 32^nd highest)

j)        Oregon                              748 (22^nd)                             18% (tie for 38^th highest)

k)      Rhode Island                   749 (23^rd)                             20% (tie for 28^th highest)

l)        Utah                                    659 (3^rd)                               11% (51^st highest, i.e. lowest)

m)    Vermont:                           721 (15^th)                             18% (tie for 38^th highest)

n)      Virginia                              762 (25^th)                             19% (tie for 32^th highest)

o)      Wyoming                           773 (29^th)                             21% (tie for 21^st highest)

Looking at this data you may note that 4 of the 5 states with the lowest death rates are in the 15 states with the lowest rates of obesity, and that none of them are worse than the 44^th highest smoking rates. (only Arizona is missing, in the next 25%-29% obesity rate and at a tie for 21^st in rate of smoking)  You may also note that the only two states in the top 15 for lower obesity rates ranking in the bottom half for death rates have smoking rates ranking at 21^st and 29^th.

Contrast this with the five states with the highest death rates:

1. West Virginia with >30% obesity and 25% smoking rate (tie for 8^th highest)
2. Mississippi with > 30% obesity and 26% smoking rate (tie for 2^nd highest)
3. Oklahoma with >30% obesity and 26% smoking rate (tie for 2^nd highest)
4. Alabama with > 30% obesity and 25% smoking rates (tie for 8^th highest)
5. Louisiana with >30% obesity and 26% smoking rate (tie for 2^nd highest)

In contrast the states with the lowest death rates have the opposite statistics for obesity and smoking rates:

1. Hawaii with 20-24% obesity and 16% smoking rate (3^rd lowest).
2. Arizona is the exception in these states with 25-29% obesity and a smoking rate of 21% (right at the national average and ranking in a 6 way tie for 20^th highest in the U.S.
3. Utah with in the 20-20% obesity and the lowest smoking rate in the U.S. at 11%.
4. California with 20-24% obesity and 16% smoking, second only to Utah.
5. Minnesota with 20-24% obesity and in a tie for 4^th lowest smoking rates at 17%.

It appears that states where citizens choose not to smoke and trend to be less obese have both lower rates of medication use and lower death rates. My guess is that the observation of lower death rates and lower rates of medication use are the result of lower rates of diabetes, hypertension, COPD, cardiovascular disease in these same states.   Yes these other health markers also trend directly with obesity and smoking rates.

So what can you as an individual learn from this?  Get fit, avoid obesity and don’t smoke.  No surprises here.

You may also enjoy:

Belly Fat is Bad for Our Health

Just How Fat are Americans?

CDC Widgets  - Go Here to calculate your own BMI and see other cool calculators

Some states have taken measures to reduce tobacco use, you can use this CDC widget to see how your state is doing, and what other states have done.

This book nicely discusses the issues of overdiagnosis in both chronic disease and in cancers.  The long-held assumption that all malignancies left untreated progress, spread and lead to death is simply not true.  We are learning that many types of cancer have unpredictable courses.  Prostate cancer is the most notorious of these, with good evidence showing that most prostate cancers are ones patients live with asymptomatically whether they know about them or not and die of something else without ever having symptoms of the prostate cancer. This is the primary issue behind the recent USPSTF “D” recommendation against routine PSA screening in asymptomatic men. There is strong evidence that some percentage of renal cell cancers, some types of breast cancer and thyroid cancers not infrequently regress or remain indolent and never lead to symptoms.

The recent evidence suggesting frequent overdiagnosis in breast cancer is very disturbing. An April 3 article in the Annals of Internal Medicine in a large retrospective review in Norway infers a 15-25% incidence of overdiagnosis in women found to have breast cancer on mammographic screening. They used every other year screening, and suggest that for every 2500 women screened 6-10 cases of overdiagnosis occurred, 20 women were diagnosed with breast cancer that was not overdiagnosis, and 1 death related to breast cancer was prevented.  We have strongly encouraged women to get annual mammograms for years. Personal anecdotal experience can make us even more confident that we are doing the right thing.  I have had many patients diagnosed with early breast cancer by mammogram over the last 20+ years, and until recently had not had any women over age 40 that I can recall diagnosed with advanced stage breast cancer who had been getting their annual mammograms.  It was very intuitive and tempting for me to believe that I was saving many lives and preventing much morbidity by aggressively pursuing early breast cancer diagnosis.  I know that I have put many women through emotionally stressful and uncomfortable additional testing, biopsies, and breast cancer treatment.  It is concerning to think that I may be subjecting some of these women to overdiagnosis and unnecessary treatment, but until we as a society actively address the issue of overdiagnosis and try to find ways to figure out which early cancers found on screening can be managed with active surveillance and which need curative treatment we are left with the inevitable overdiagnosis dilemma. This will  involve asking a cohort of women with various very early cancers to be observed for progression prior to intervention.  Whether this is going to be acceptable is not clear.  We need to do the same thing for men with early prostate cancer.  We are following lots of men with prostate cancer, but as far as I know not in a formal study that will give us help in knowing which cancers can be safely followed.  For now I’m doing nothing different except keeping my eyes wide open to further research and recommendations.

Much of what we do in medicine today is aimed at early diagnosis of asymptomatic disease, and overdiagnosis is a very valid concern any time we are screening for asymptomatic disease. The recent changes in criterion for hypertension, diabetes and hypercholesterolemia are leading us to the preventative treatment of many diseases that are of themselves asymptomatic.  The whole issue of overdiagnosis is going to be fascinating to follow over the next decade or two.

You may also enjoy:  PSA Controversy Continues

One other comment is that the video implies that only if a large heart attack occurs is cardiac arrest likely.  Actually even small heart attacks, and likely even episodes of coronary ischemia not severe enough to cause actual death of cardiac tissue can lead to cardiac rhythm disturbances, a.k.a. cardiac arrhythmias that may cause cardiac arrest and sudden death.

The key to preventing coronary artery disease, heart attacks, heart failure and cardiac arrest is to lower your risk of developing atherosclerosis.  The primary risk factors are tobacco use, high blood pressure, diabetes, lipid abnormalities like high LDL cholesterol and low HDL cholesterol, obesity and sedentary lifestyle. In some cases other familial factors play a role, but most often a strong family history of heart disease is because of a hereditary tendency to one or more of these risk factors.

So what do you do? In order of importance in my opinion:

• Don’t smoke.  If you do smoke quit now.
• If you have high blood pressure be sure it is well controlled.
• If you have diabetes do everything you can to control your blood sugars.
• If you have high LDL cholesterol and other risk factors discuss use of a statin or other lipid lowering medications with your doctor.
• Stay fit.  Exercise regularly, reduce your dietary animal fat intake, and lose weight if you are overweight or obese.
• If you already have atherosclerotic vascular disease, i.e. if you have had a heart attack, stroke, or peripheral artery disease even more aggressive treatment of risk factors like high cholesterol, high blood pressure, obesity, and diabetes is important.  Ask your doctor about how to accomplish these things.
• Ask your doctor about taking an aspirin daily.

This same issue occurs with everything from surgeries to chiropractic care.  I remember in medical school that one student in our class was traumatized by the sudden death of his patient right in the middle of his first time alone with a patient for a physical exam.  Did he do something to cause her death?  Almost certainly not, but still he was likely pretty anxious the next few times he did a physical exam.

The natural course of many self-limited illnesses makes post hoc ergo propter hoc relationships very common. If you have a sinus infection that is going to last 10 days, but you see the doctor on day 8 and get an antibiotic, are told the medication should help within 2-3 days, when you recover in 2 days it is natural to credit the recovery to the antibiotic.   If you get a headache the day after you start a new medicine, or a rash when you have been on the medication for a few days then post hoc.  The relationship is assumed.

This issue is discussed very nicely in a recent article in Forbes by Henry Miller:

The Data on Drugs’ Side Effects Must be Reliable

As a medical resident at a major cancer center some years ago, I was responsible for administering a 4 a.m. intravenous dose of a drug that was part of the patient’s treatment protocol. I stood by the patient’s bedside, groggily flicking and tapping the syringe to get the last tiny air bubble out of the drug before injecting it.

Just as I was about to push the plunger to administer the drug, the patient died — just stopped breathing and expired. There was a “do not resuscitate” order, so sadly, that was that. The time was 4:01 a.m.

Had I more quickly removed the air bubbles and administered the drug at exactly 4 a.m., the patient would have died within seconds of receiving it. As a result, the investigators on the treatment protocol, the maker of the drug, federal regulators and I would all have suspected that the drug was the proximate cause of death.  Read more

This post hoc issue plays havoc with everything from medication side effects reporting to patient’s expectations for treatment. I think it is an import concept to keep in mind when we try make sense of what we observe in live and medicine.

Why don’t I do a better job?  I suspect it is a combination of factors.  I think the first is that this is rarely high on a patients list of topics they want to discuss at an office visit.  It is easy to put off this discussion when seemingly more pressing issues are the patient’s expressed reason for the office visit.  Even at physical exam visits, or in the medical coding lingo “preventative care” or “health maintenance” visits, it is alluring to focus on topics that lead to a longer or healthier life rather than a better death experience.  Here is the list of the physician-related barriers to completion of an advance directive listed in the AFP article:

• Discomfort with the topic.
• Lack of institutional support.
• Lack of reimbursement.
• Lack of time.
•  Waiting for the patient to initiate the discussion.

In my case it is certainly not discomfort with the subject, and I am not intentionally waiting for the patient to bring up the subject, but lack of time and reimbursement undoubtedly play a role.

In addition most patients really don’t need my help in working through this decision process if they address the issue before there is a crisis. Although there are cultural, personal and ethnic variables that shape our decision making, most of my patients can  really quite quickly and easily work through the process of completion of both a very functional living will and a durable power of attorney without my assistance.  So why doesn’t everyone just do it themselves?  Here are the barriers listed in the AFP article that are patient related:

• Fear of burdening others, i.e. family or friends.
• Health Literacy
• Lack of interest or knowledge of the subject.
• Spiritual, cultural or racial traditions.
• Waiting for their physician to initiate the discussion.

So how can you just “Do it yourself?” It’s really easy.  Obvoiusly since you are reading this article you have access to the internet, and everything you need is just a few clicks away.  I encourage you, if you have not already completed these documents, to DO IT NOW:

1. Down load your state’s Advance Directives at the caringinfo.org site.  This is really easy and you can get everything you need by selecting your state from the list here.
2. Many states have a form called a POLST form.  This stands for physician orders for live sustaining treatment.  If you use a search engine like Google, and you type in your state + POLST form you will easily find a form to download if your state has a POLST form.  You can get the Washington State form to download easily at WA POLST download.  Many physician offices have these available, just ask your doctor.
3. For some people a form to help you ascertain your values on this subject and to make your values clear to the individual you choose to have your medical power of attorney is helpful.  The University of New Mexico  Institute for Ethics has published online a non-copyright protected form for you to download.  Some patients will find it helpful to attach this to their advance directive as guidance to their proxy in making decisions in line with their values.

There you have it.  You have no more valid excuses to keep you from completing your own advance directive and living will.  Once you complete it be sure to not keep it a secret.  Give a copy to your physician, to the person you choose as your DPA, and keep a copy handy at your home.   Don’t be a victim of your own procrastination or discomfort with this topic.  If you find it helpful ask questions on the subject up with your personal physician.  Be sure to let them know you have these documents completed.

In my best cheer-leading mantra:  You can do it!  Go – Go – Go!

I see patients, parents, grandparents, siblings, friends and lovers concerned about suicide in the office from time to time.  Other times I am the one concerned about suicide in patients I think may be at risk.  Suicide is I a big and growing concern in the U.S. these days and I thought this would be a good time to write about this topic to share some statistical information and some thoughts. I hope to stimulate a forum for comments and sharing of thoughts in the comments below.

First some thoughts:

• I think of suicide as the ultimate in selfish behavior most of the time. The purported victim leaves behind many other victims of their act. Family, loved ones, friends, associates and their whole community are left to grieve, often filled with guilt over the lost soul. Don’t ever think of suicide as leaving the world better off without out your presence, you will leave far more sadness and grief behind that if you live.
• Never be afraid to ask anyone if suicide is a concern.  They may lie and say no, but often people with suicidal intent will admit their concern if directly and empathetically asked.
• If you have concerns about suicide for yourself or someone else ask for help. There are 24-hour crisis lines available, your physician, pastor, or other professional is obliged and usually happy to try to help.
• Never think of a half-hearted suicide attempt as a way to find help.  Miscalculations or other mishaps can make a suicidal gesture (not really meaning to kill yourself, but really asking for help) into a successful suicide all too often.

Is suicide the epitome of selfishness?  I was initially taken aback when a person I completely respect told me how angry he was about a colleague who had committed suicide, telling me how selfish he though the person had been.  I had not thought of suicide as a selfish act previously, but have thought a good deal about it since.

I see patients, parents, grandparents, siblings, friends and lovers concerned about suicide in the office from time to time.  Other times I am the one concerned about suicide in patients I think may be at risk.  Suicide is I a big and growing concern in the U.S. these days and I thought this would be a good time to write about this topic to share some statistical information and some thoughts. I hope to stimulate a forum for comments and sharing of thoughts in the comments below.

First some thoughts:

• I think of suicide as the ultimate in selfish behavior most of the time. The purported victim leaves behind many other victims of their act. Family, loved ones, friends, associates and their whole community are left to grieve, often filled with guilt over the lost soul. Don’t ever think of suicide as leaving the world better off without out your presence, you will leave far more sadness and grief behind that if you live.
• Never be afraid to ask anyone if suicide is a concern.  They may lie and say no, but often people with suicidal intent will admit their concern if directly and empathetically asked.
• If you have concerns about suicide for yourself or someone else ask for help. There are 24-hour crisis lines available, your physician, pastor, or other professional is obliged and usually happy to try to help.
• Never think of a half-hearted suicide attempt as a way to find help.  Miscalculations or other mishaps can make a suicidal gesture (not really meaning to kill yourself, but really asking for help) into a successful suicide all too often.

Next some statistics that I find interesting and informative:

• N 2007 suicide was the 10^th leading cause of death in the U.S.
• Although persons of all ages may commit suicide young men and the elderly are by far at highest risk. The incidence of suicide in adolescents ages 15-19 is 6.9/100,000, in young adults 20-24 is 12.7/100,000 and in adults 65 and older 14.3/100,000. In the age range 15-19 males are 5x as likely as females, and in 20-24 males are 6x as likely as females to die of suicide.
• Access to firearms is a major risk for successful suicide.  Children in homes with firearms are 10x as likely to die of suicide as children in homes without firearms.
• Both men and women die of firearms related suicide but males are especially at risk. 56% of male suicides involve firearms vs. 30% of females.  Males are also more likely to die of suffocation than females at 24 vs.21%.
• Females are far more likely to die of poisoning at 40% vs. 13% than males.
• Gay young men are especially at risk for suicide.  See comments below.

Risk factors for suicide include:

• Prior suicide attempts
• Mental health problems
• Drug or alcohol abuse
• Separation or divorce
• Physical or sexual abuse
• Being young and gay.  Several studies show higher risks of suicide in gay male adolescents.  Risk estimates range from 2-10x. (1,2)
• Returning veterans of the recent Iraq and Afghanistan wars are at risk.

So what can we do to keep suicide from affecting those near us?  I suggest a few things. 

• If you choose to have firearms in your home, take rigorous precautions to keep them away from adolescents.  Recognize this as a major risk factor.
• Even if you do not suspect any concern, make the topic a regular subject to bring up with your child.  Be sure they understand that suicide is not acceptable, and that you are very willing to help them in any way if suicide becomes remotely a concern.
• Take any suicidal hints or references very seriously.
• Keep prescription and non-prescription medications well away from youth.  Buy non-prescription drugs in small quantities or keep larger quantities locked away.
• Never think of suicide as beneficial to others. It is strictly a selfish exit from life, and leave behind others to struggle with your loss as well as all of their own problems.  It makes nothing better.

I’d love to hear comments from readers. Leave a comment below.

I’ve heard from patients and red in the news about the fact that Pradaxa cannot be reversed with vitamin K like warfarin can. I think this is a seriously flawed argument. The Pradaxa half-life is short enough that requires twice daily dosing (12-17 hours) and within about 36 hours after the last dose of Pradaxa it’s anticoagulation effect should be largely gone in patients with normal renal function. When using vitamin K as an antidote warfarin it takes a day or two for significant hepatic metabolism of the coagulation factors inhibited by warfarin and I seriously doubt if use of vitamin K leads to a reversal of the anti-coagulation in warfarin patients any faster than or even as fast as simply discontinuation of Pradaxa therapy. It’s true that in major emergencies either fresh frozen plasma or other coagulation factor products can be used as an infusion to reverse the quite neuropathy in warfarin use. Pradaxa works directly as an inhibitor of coagulation, so its anticoagulation effect should be less responsive  to this type of therapy. Still I suspect that the argument that there’s no antidote for Pradaxa is less important clinically than it sounds in newsprint.

It will be interesting to see how the aftermarket evaluation of Pradaxa and the other newer anticoagulants bears out. Patients taking Pradaxa seem to certainly appreciate not needing to have frequent coagulation clinic visits to monitor their quite elation status necessary with warfarin use, and so far thankfully I’m not aware of any of my patients who have had bleeding complications from Pradaxa. I seem to see the current local cardiologists still prescribing Pradaxa fairly frequently and my expectations are that as more data comes to bear on the situation Pradaxa will be found to have a bleeding complication rate fairly similar to warfarin. Stay tuned for more updates regarding Pradaxa side effects and efficacy as they become available.

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.

How Doctors Die by Ken Murray a FP at USC.  

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

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

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

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

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

Polio Eradication

Eradication of Polio: It’s Happening

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

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

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

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

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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.

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

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

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

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

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

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

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

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

Should We All Go Gluten Free?

By Keith O’Brien November 25, 2011. 

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

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

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

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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 

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In the study patients had their colon cleared of feces and a large volume replacement with feces of another person, usually a relative. The reports that I could find did not go into detail as to just how this was accomplished, but it must involve clearing the existing feces from the sick patient’s colon, and replacing it with the feces of another person. I can just imagine the response I’d get from the nurses asked to do this if I ordered it on the hospital’s medical ward. I suspect it would be something like, “You want me to do what?” or “Are you sure another course of vancomycin is not a better choice?” Care of a sick patient getting a bowel prep for colonoscopy is no fun, but following that with a large volume feces enema! Now that has a very high “yuck” factor. Add to that collecting the feces and storing it for transplant and you have a procedure that is certain to bring a groan from the staff tasked with executing the details.
Hopefully we as a medical community can get past this prejudice against handling feces. The study, if it holds up to further scrutiny, sounds almost too good to be real. Dr. Mark Mellow and others from Integris Baptist Medical Center in Oklahoma City reported on 77 of the toughest C. diff. patients. These patients were old, had an average duration of the C. diff illness of 11 months, and 31 of the 77 were hospitalized, homebound or in a nursing home when the procedure was performed. Nearly all had been treated with vancomycin and other traditional therapies. 91% of the patients no recurrence at 3 months follow up, and this rose to 98% with additional treatment and repeat fecal transplant.
The procedure has a lot of things to overcome, the Yuck factor being just one. It has no pharmaceutical backing, i.e. no one has patent on feces, and so there is not big money to back further studies. Still, hospitals who are losing big money on long hospitalizations for patients with C. diff. colitis should be very excited to have a low tech, low cost treatment that really works for a disease that has been a huge problem leading to long and expensive hospitalizations. Also the procedure is somewhat sensational which may induce others to replicate the study and report their findings. Look at how much press the initial case presentation has garnered. Hopefully these factors will lead to further study and result in convincing evidence that this is an effective and safe treatment of refractory C. diff. and we will get past the smelly and yucky excuses not to perform fecal transplant. It sounds like the procedure is still a ways from ready for prime time, but it sure sounds promising. Human feces is a tremendously complicated ecosystem, and the thought that we can somehow kill off all the bacteria in the gut and get them to grow back right without replacing them with the real thing is maybe naïve. Fecal transplant may be just the answer to a stinky problem.

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