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Tuesday, February 2, 2016

Old Fangak, South Sudan--Bedside Ultrasound and other stuff

I just got back from a couple of weeks in Old Fangak, a community of people living by the Zaraf River in South Sudan. It's normally a small community, with an open market and people who live by raising cows, trading on the river, fishing and gardening. Now there are tens of thousands of people there, still displaced from their homes by the civil war which has gone on intermittently for decades. There are even more people now than there were last year.

There is a hospital in Old Fangak, which is run by Jill Seaman, one of the founders of Sudan Medical relief and a fierce advocate for treatment of various horrible and neglected tropical diseases, along with some very skilled and committed local clinical officers and nurses and a contingent of doctors, nurses and support staff from Medecins Sans Frontieres (Doctors Without Borders, also known as MSF) who have been helping out for a little over a year. The hospital attempts to do a lot with a little, and treats all who present there with whatever is available to combat their myriad ills. There are special programs for children with severe acute malnutrition, for patients with tuberculosis, kidney disease, Kala Azar, including food distribution for a subset of people with chronic illnesses.

I've been to Old Fangak 3 times now, always in the winter (warms my toes for a few weeks) during their dry/cool season. Cool means that it doesn't get much above 100 degrees during the day and cools down to sometimes below 70 at night. My stated purpose in going is to teach Jill and anyone else who wants to learn how to do bedside ultrasound. I love teaching people to do ultrasound and it means that a 2 week trip can actually have some long lasting benefits. I also get to be a general all purpose doctor who can give shots to babies, sew up lacerations, trim down leprous calluses, ponder the etiology of obscure illnesses and cook dinner. I get to see how the staff at the hospital manages to do the loaves and fishes trick with far too many diversely sick people and far too few resources.

They have a work horse of a Sonosite MicroMaxx ultrasound machine which is good for anything from babies to hearts to fractures and abscesses. I got to teach a midwife who has seen other people use ultrasound but hasn't been able to do it herself, an ER doctor who had only previously learned to do ultrasound to identify blood in the abdomen in patients with blunt trauma and a nurse who will likely make international medicine her career and was an awesomely quick study. Jill was already quite good with obstetrical ultrasound but became more confident with hearts and abdomens. Everyone learned how to make gel with glucomannan powder for when the carefully hoarded real ultrasound gel goes mysteriously missing. I brought my Vscan (little pocket ultrasound) for ultrasounding on the fly, and that was really useful as well.

An ultrasound machine paired with a person who can use it makes a big difference to care in the US, but is life-alteringly amazing in a rural hospital in Africa. What, you might ask, was it good for?

  1. An old woman limped in with a hard lump sticking out of the top of her foot. It had been swollen in the past, but now just hurt. It started when she kicked a tree. I can check it out by putting her foot in a tub of water and using the ultrasound transducer to see whether the little lump is a foreign body or a bone. Unfortunately it was a bone, sticking out of the top of her foot. Ouch. Not a lot to be done for that in this situation. 
  2. Babies. So many babies! One night there were two sets of twins delivered in one hour. The ultrasound could confirm the positions of the little tykes and predict the ease of delivery. The first pair were both head down and came out without a hitch. The second pair were smaller, worrisome for prematurity, and after the first one emerged (squalling nicely) the second one was lying in a transverse position. With a little manipulation from the outside, she was able to flip so that the head was down and was delivered without incident. There were slow or obstructed labors and being able to know that the baby was alive and well meant that the mother could be motivated to push hard even though she was really tired. 
  3. Abdominal pain in a person with known hepatitis B: Hepatitis B is unfortunately still quite common, and vaccination is not standard. One relatively young woman had been treated for hepatitis B but was having pain in her abdomen. The ultrasound showed a small nodular liver and ascites, but a small enough amount that removing it might be dangerous and certainly wouldn't make her feel better. Treatment with anti-viral medications was indicated, paracentesis (removing fluid from her belly) was not. 
  4. A pregnant woman was very anemic and also nauseated and unwilling to eat. On ultrasound her baby is still doing OK, but her amniotic fluid level is a bit low. When the transducer peeked around the uterus there were multiple loops of large bowel that are filled with fluid and thickened. In this situation the most common cause of such a finding is giardia, an endemic intestinal parasite. She got intravenous hydration, treatment for her giardia and her nausea magically resolved. She had lain in the hospital for over a week being miserable, but the ultrasound was able to point us towards the right diagnosis. 
  5. Heart disease is common there as it is here, but in Old Fangak it is primarily due to birth defects or rheumatic fever. A man presented to the hospital with swelling of his legs and shortness of breath. He was exhausted. He hadn't been able to lie down to sleep for months. He was treated with diuretic medication and beta blockers to slow the heart and improved quite a bit. The ultrasound showed advanced rheumatic heart disease, with a stenotic mitral valve and a leaky aortic valve. It was nice to know, and perhaps an email to specialists in Khartoum, the nearest city with really high quality medical care could secure him the heart surgery he needs. Probably not, but it's worth a try. There were children with signs of heart failure due to ventricular septal defects and a young woman as well, probably with an atrial septal defect. They could live relatively normal lives with heart surgery, but the Italian group that used to do this for free in Khartoum is no longer providing that service. They will get medicines which will work a little bit and they will probably die young. Stuff like that is hard to watch.
  6. Pus. People come in with swollen hands, fingers, thumbs, feet. There was a guy with a swollen thumb. After the obvious pus was drained there was still pain and swelling. We could see with the ultrasound that there was very little pus left to drain, but that the bone in the last joint of the thumb had broken due to the infection, suggesting a need for amputation of that bone. Another guy had a swollen finger, with pus on both sides of the tendon. This guided the drainage procedure. He didn't have obviously infected bone and might well recover the full use of his index finger. 
  7. People also became desperately ill sometimes, short of breath, low blood pressure, that sort of thing. A woman with a history of heart problems in the past came in unable to catch her breath, with a fever. Ultrasound showed that her heart was doing just fine and that her inferior vena cava was very small supporting a diagnosis of sepsis and pneumonia and leading to successful treatment with fluids and antibiotics. Another woman had known kidney failure and came in with a cough. The ultrasound also showed normal heart function, an abnormal left lung and dehydration in her. She was treated with intravenous antibiotics and fluids. The next day the inferior vena cava was full, meaning that she did not need more fluids, and her bladder was full as well, showing that she did have some residual kidney function. Her overall prognosis is terrible, but she was able to survive another few days at least. 
So bedside ultrasound clearly rocks. Living in South Sudan and being sick does not. 

Saturday, January 16, 2016

Annoying acronyms and miserable mnemonics: AIDET and the H's and T's

Mnemonics can be incredibly cool. When I was in medical school there was just too much stuff to remember and memory aids were so very helpful. Most specifically I refer to the vile and inappropriate one that helped me remember the cranial nerves which I remember to this day and will not share in print. In ancient times orators used memory palaces to memorize long speeches or poems, associating words with familiar and sometimes bizarre images. All this is to say that I have nothing against a good mnemonic. Lately though, as I have struggled to memorize a new acronym which is supposed to be good for me, I've been thinking about what makes a mnemonic good and what makes one annoyingly terrible.

The most irritating mnemonic in recent experience is probably the "H's and T's" from Advanced Cardiac Life Support (ACLS). When a person's heart has ceased to be able to sustain life or blood pressure, we use a memorized sequence of interventions to resuscitate them, the ACLS protocol. Ideally, we would all be fast enough and coolly competent and use our diagnostic skills and knowledge of treatment to rapidly and effectively help the patient recover in short order. The fact is that, for most of us, a cardiac arrest occurs rather infrequently and is associated with enough anxiety that, without a good solid script, shared with a treating team, we might just stand around and flap our hands and mumble. With the script we sometimes are able to restore a functional cardiac rhythm in time to keep from irrevocably damaging the brain. But if we try the usual maneuvers and nothing works, we are encouraged to think of the H's and T's. I have studied this for years and still I find that these letters do not help me much at all. That is because humans are not good at thinking of many things that start with the same letter. That's why the game Scattergories is actually challenging. A mnemonic has to be really good to work in a life and death situation. 

In order to help me maybe remember the H's and T's again, here they are. If a person persists in being dead despite your best efforts they may have: hypoxia, hypovolemia, high hydrogen ion (acidosis), hypothermia, thrombosis of the coronary or pulmonary circulation, tamponade, tension pneumothorax or toxins (poisoning.) And don't you forget it!

The other annoying acronym is AIDET, a communication tool introduced by healthcare consultants the Studer group to help improve patient satisfaction. The Studer Group arose out of the experience of Quint Studer in using a business model to improve patient and employee satisfaction in a failing hospital. Many hospitals could use help and Studer techniques have become very well accepted by management in hospitals, though somewhat less enthusiastically by clinical staff, who right or wrong do not feel like they need a script in order to communicate. AIDET stands for Acknowlege, Introduce, Duration, Explanation and Thank You. As a grammar police person I resent the fact that these are different parts of speech. Two are verbs, two are nouns and the last one is two words that make up a sentence. If one does by some chance memorize the words the problem may reasonably arise that they don't actually tell one what to do. After attending a workshop one might learn that one is supposed to say, "Good morning, Mr. Qwerty. My name is Jkl;. I'll be working with you today in what I hope is your most awesome and joyful healthcare experience ever. In 15 minutes your anesthesiologist, Dr. Asdf will be in to assess you for your surgery scheduled for 2 PM today. You will not be able to eat prior to surgery but we will  be happy to get you a late tray when you return. Thank you for allowing us to work with you today. We know you have many choices and  we are happy you chose X hospital."

AIDET is not entirely bad. Maybe it's not mostly bad. But it is also not great. First the acronym/mnemonic. It doesn't work. That's one reason why hospitals have to get their employees to attend practice sessions to absorb it.  And they do. I have failed to attend a practice session myself and, once I get back from Africa, I will likely need to do remedial work. A good mnemonic is ABC for airway, breathing, circulation, the recently replaced beginning of cardiopulmonary resuscitation (now CAB.) Or "righty tighty, lefty loosey" for opening a valve. Using AIDET to remember to recognize a patient, introduce oneself, explain what will happen and when and express gratitude of some sort is like grabbing for a cement life preserver. Maybe "who, what, when, where, why and hurray for you" or something goofy like that could work. The AIDET acronym is actually copywright protected so maybe that's why they push it--if you use it you have to pay Studer Group. Also the content and the concept is less than great. I accept that doctors and nurses often need to slow down and introduce themselves and explain what's going to happen, also to affirm the worth and dignity of the patient. But we need to do it in our own way, otherwise we lose our own dignity and will fail to notice what this patient needs at this particular moment. Patients will also start to notice that we are talking strangely. 

Monday, October 26, 2015

How can we start coming up with new therapies that actually save money?

In the United States, biomedical research, including basic science and clinical studies, is paid for mainly by companies that expect to make money off of new discoveries. The government, through the National Institute of Health (NIH) funds a little over a quarter of it, but most of the money comes from drug and device manufacturers.

This means that interesting research that might result in breakthroughs that save patients money is unlikely to find funding. This is terrible. If gummy bears cured cancer, we might never find out about it. If anything that is easy to come by, from various sources, were to show promise therapeutically, we as US citizens would not be likely to find out about it through our own research.

Some examples:

1. Red yeast rice, a dietary supplement made of rice fermented with the fungus Monascus purpureus in a centuries old process, contains a widely marketed cholesterol medication (lovastatin) that is naturally produced by Monascus. The doses are high enough to reduce cholesterol significantly. The best study of this product was done in China, with an extract of the yeast rice, and showed that it reduced bad heart outcomes more than did lovastatin in clinical trials here. The FDA has banned red yeast rice periodically (though it is now easy to find online) saying that it could be dangerous. For awhile, the only red yeast rice products that could be sold in the US were ones which either didn't mention how much active ingredient they contained, or contained little to none of it. Now that we can buy it again, it is unclear which brands actually work to reduce cholesterol.

2. Aspirin, which was first widely adopted for treatment of pain and fever in the late 1800s, was found in the 1970's to be very effective for treating and preventing disorders due to blood clots, particularly heart attack and stroke. I wondered how, since this drug was widely available at a very low price, research had been done in the US to show how effective it was. It turns out that the groundbreaking work was done in Britain, where most research is funded by the government (which would stand to gain, along with patients, from discovering an inexpensive approach to a common problem.) To be fair, in the 1970's research in the US was much more often paid for by the government, so the aspirin research probably could have been done here.

3. Corticosteroids (prednisone and others) are widely available and inexpensive medications which reduce inflammation. They have various side effects and so are used sparingly in most situations. It turns out that, when used along with antibiotics in severe community acquired pneumonia, they make people improve faster and die less frequently. A review of 13 randomized controlled trials came out in the Annals of Internal Medicine earlier this month. Dr. Reed Siemieniuk was the first author. He and his coauthors are from Canada and Europe and the vast majority of the articles reviewed were done in Europe. Studies like this don't happen in the US because drug companies have no incentive to fund them. Full color, full page ads or TV infomercials will not tout the importance of this discovery, so it will be a little more difficult than it might be to change the habits of US physicians to incorporate this life and money saving approach.

4. Nicotinamide, also known as vitamin B3, a derivative of niacin, was just reported to reduce pre-cancerous skin spots, known as actinic keratoses. These are the little scaly spots that happen on the arms, heads and faces of aging people who have spent time in the sun. It also appears that topical nicotinamide may do the same thing, as well as reducing wrinkles and other signs of aging. This vitamin is available widely and costs pennies a pill. How could such research have been done, since this discovery will likely decrease the amount of money spent on other expensive treatments and prescription potions for this problem? It was done in Australia, funded by the National Health and Medical Research Council. Nicotinamide, though it is related to Niacin, does not cause flushing and does not reduce cholesterol levels, though it has reversed symptoms of Alzheimer's disease in an experimental mouse model.

What can we do in the US to re-purpose our considerable intellectual resources and vast research machinery away from increasingly complex and costly new technology and toward elegant and ingenious cost-saving approaches? In the big picture, we could figure out a way to move money that will likely be spent on useless or overly expensive healthcare toward research that leads to lower consumption of resources. The NIH in the US is the organization that can fund non-biased research, and is perfectly suited to doing so. Money spent on cost-saving technology will pay for itself many times over.

Drs. Arthur Kellermann and Nihar Desai, from Bethesda and Yale respectively, discuss in a recent JAMA article several specific recommendations from RAND health, a think-tank charged with improving global health and reducing costs. These include creating a public-interest investment group to fund good projects, giving cash prizes to inventors, buying out patents to allow reasonable pricing and reducing unnecessary regulatory hurdles. They conclude:
"Realigning incentives to encourage inventors and their investors to develop cost-lowering products could transform technology, which is currently one of the most potent drivers of health care spending in the United States, into a powerful creator of value. Once that is done, ingenuity will take care of the rest."

Sunday, October 18, 2015

Repatha and Praluent: VERY expensive drugs to lower cholesterol which may not actually work to prevent heart attacks (then again, perhaps they will.)

In July of 2015 the US Food and Drug Administration (FDA) approved an injectable monoclonal antibody alirocumab (Praluent) which lowers the LDL or "bad cholesterol". The drug is produced by Regeneron, given by injection once every 2 weeks, and will cost $14,600 wholesale per year. In August, evolocumab (Repatha) was FDA approved. It, too, is a monoclonal antibody and will cost $14,100 wholesale when it is finally released. It was developed and will be marketed by Amgen.

These drugs are antibodies, produced in hamster ovary cells in vats, which, when injected, bind to proprotein convertase subtilisin/kexin type 9 (PCSK9), making it less active. PCSK9 normally reduces the liver's ability to remove low density lipoprotein (LDL) from the blood. The main drug class that we have now which reduces LDL is the statins, also known as HMG CoA reductase inhibitors, which reduce the production of cholesterol. A couple of common statins are atorvastatin (Lipitor) and simvastatin (zocor.) I have ranted about them copiously in the past.

The reason we worry about LDL is that high levels of it seem to be associated with heart attacks and strokes, and people with a genetic defect that raises their LDL to very high levels often die young of heart attacks. There are many drugs which can lower the LDL levels, but the statins work best and also have been shown to reduce the risk of heart attacks and strokes in high risk patients. The studies are less clear about their benefits for lower risk people. Many drugs which lower the LDL do not reduce the risk of strokes or heart attacks, and it may be that statins have positive effects due to their reduction of inflammation or some other positive effect on blood vessels.

In 2013, recommendations from the American Heart Association and the American College of Cardiology changed from recommending using medications to lower cholesterol below certain levels, depending on level of risk, using diet and medications, to simply using statins for everyone at elevated risk of vascular disease, such as heart attack or stroke. Statins don't appeal to everyone, primarily due to side effects of muscle pain and weakness, also sometimes problems with thinking and memory, so this approach is not universally applicable. But with statins now mostly generic, this approach costs only about $150 per year and is pretty effective.

There is another problem with this approach (besides the fact that it puts huge numbers of people who might never have trouble with vascular disease on a statin drug with unclear long term side effects). There is no room in these statin-based recommendations for non-statin drugs, especially absurdly expensive ones that were finally released after more than 10 years of research by powerful drug companies.

The PCSK9 drugs have been approved for use in patients with familial high cholesterol syndromes and those with known disease of the coronary arteries whose cholesterol remains high despite statins. Insurance companies and anyone else with concerns about rising medical costs are concerned that doctors will start prescribing these drugs with gay abandon to everyone whose cholesterol worries them, with a multi-billion dollar impact on health care costs. The drug companies promise to provide the drugs for less money to patients who can't afford them and to cut deals with insurance companies, but the costs may still be staggering.

In the last two days I saw two articles suggesting that we start to obsess about cholesterol levels again, shifting away from the recently accepted approach of simply treating everyone at high risk of heart disease with statins. The first, in JAMA, was authored by 3 physicians employed by the healthcare company CVS, saying that if we don't start checking LDL levels and targeting higher ones for treatment, anyone with very high risk will be put on PCSK9 injections. CVS, as a pharmacy benefit management company, stands to lose money if patients' drug bills go up astronomically. Then again, they might pass the costs on to consumers and manage to make money. Plus CVS sells point of care cholesterol blood tests, so I'm not sure where their interests lie.

The second was an "educational activity" presented by Medscape, featuring a discussion by 3 physicians with academic affiliations (two from Harvard Medical School) who would all like to go back to checking LDL levels and using medications to get the LDL as low as possible so as to reduce the risk of heart attacks. The activity was financed by Regeneron and Sanofi, who make the new injectable super expensive cholesterol drug, and all of the experts have been on the payrolls of one or both of the companies that produce these drugs. They are very excited about how well these new drugs lower the LDL, and they expect that when studies come out looking at reducing risk of heart attacks they will actually have some clinical benefit. They talk about how many patients might be "candidates" for this therapy, as if it's some kind of a sought after political office. That part is just plain creepy.

There are so many problems with all of this. First and most importantly, we don't know if these super expensive drugs actually reduce the risk of heart attacks. We won't know until 2017, when the first of the many studies which are ongoing will be available. It doesn't matter at all if they lower LDL levels, since high LDL levels aren't actually a sickness. The excitement about this new drug will again focus us away from the fact that lifestyle changes such as quitting smoking and becoming at least moderately active are even more effective in reducing risk for all kinds of vascular disease and other miseries than any medication we have produced. It's very likely that patients who continue to smoke and abuse their bodies in other ways will be put on these drugs, because those are the patients who are at highest risk of heart disease. Do we really want to be directing resources in this direction?

And what about the cost? Why $14,600 per year? What a crazy number. Probably we should just shelve it until we know if it works, then, if it does, figure out who actually needs it.


Friday, October 2, 2015

Medical bills: why are these completely inscrutable and full of mistakes?

Within the last two days I received a bill for my glasses and read a post by a friend ranting about medical billing mistakes. This is a huge problem that is so common that it could be considered the norm. It is ridiculously expensive and could probably be fixed.

My exposure to medical bills has been through patients who show them to me, hoping I can make sense of them, my occasional foray into the world of being a healthcare consumer and the woes of friends and family. I can say, with confidence, that I have never read a medical bill that I understood. When I do choose to dig a bit deeper, overcharging and errors are more common than not.

It is very hard to get good statistics on this, but the lower end of what I'm seeing suggests that one in 10 bills contain errors. It's probably higher than that.

Common billing errors include being billed for procedures that were cancelled, being billed twice for the same thing, under different names, being billed for a more complex version of what was actually done and being billed for more time than was actually spent. How do these happen? In general the errors aren't deliberate fraud. Frequently staff in the billing office do not talk to doctors but produce bills based on what the doctors write. Doctors don't document what happened right away if they are busy and so by the time they do make a note, details are often fuzzy. In the case of billing for canceled procedures, the only paper trail available to billers may be the order for the test, and the cancellation may have been communicated by voice, on the fly. When doctors do bill for themselves, it may be difficult to find the correct code, so, in a hurry, we just settle on the first one that resembles what we did. Most of us are not interested in getting better at billing because we hate it. We weren't trained to do it and it takes us away from patient care.

Patients often (but certainly not always) know what did happen. Their bills, though, are written in some long forgotten Martian dialect which makes it really difficult to correct the errors.

My bill for glasses, which turns out to have been correct (after two phone calls) is a good example of what is wrong with medical bills. I apparently owed $137 for "lens sphcyl bifocal 4.00d/0.1, and $155 for "progressive lens per lens" and also more money for "lens polycar or equal" (which I would have assumed was my lens sphcyl, but I guess not), also the anti reflective coating and a miscellaneous vision service and a miscellaneous product which apparently meant that they charged to drill a hole in the lens and polish it. Sales tax I could figure out on my own. Also the bill didn't say anything about insurance, which does pay some portion, and the biller was not planning to submit it. A separate bill has arrived detailing the cost for my exam, also written in some language that I don't speak. The bills are dated a week apart, for unclear reasons. Theoretically I should be pretty well positioned to understand this sort of thing, after 3 decades in the medical field. I'm guessing others, who might be less educated, sicker, more fatigued or less assertive would simply give up and not check the bill at all.

My friend's issue was being billed for copays that he actually paid at the time of service, then getting notices that he was delinquent for not paying them, having to call the billing office multiple times and eventually having to appear in person in order to get it fixed.

Because billing in excess of services usually leads to making more money, there is no real economic incentive to do this right. A responsive and intelligent problem solver in the billing office may actually lose the practice money, if he or she uses the relevant skills to solve customer complaints. The only economic reason to reduce inadvertent overbilling is to avoid being caught and penalized by insurance companies. There are definitely medical billing specialists who delight in doing their jobs accurately, but there is no cash reward for this sort of behavior.

The most effective first step toward taking care of the problem would be a requirement (it could even be a law) that medical bills be descriptive enough that regular people can actually understand them. The affordable care act made health insurance companies describe their services in ways that average people could know what they were buying. If people could actually read and understand their bills, they could see if they were correct. We could even tack on to the law a time limit for resolution of a query. Wouldn't it be sweet if a billing question would be fielded in 24 hours and resolved in a week? That doesn't sound too difficult.

The whole issue of medical billing is, of course, wrong in a very big way, since its existence is based on fee for service. As long as providers can make more money for doing more things and more complex and difficult things, their will be economic pressure to do more intense medicine on more people, thus creating more people who have been medicalized into being sick. We do, though, have fee for service medicine at present, so it's time to support the (not yet written) "Medical Bill
Clarity Act of 2015."

Sunday, September 13, 2015

Marketing medicine and the treatment of high blood pressure

I just read a disturbing article about a recently completed study on treating high blood pressure. The SPRINT (systolic blood pressure intervention) trial was conducted at around 100 locations in the US and Puerto Rico, comparing treating blood pressure intensively to usual care. According to recently adopted guidelines, we now treat blood pressure with the goal of reducing the top number, the systolic blood pressure, to below 140 for adults younger than 60 and below 150 for those 60 an over. The goal for the bottom number, the diastolic blood pressure, is below 90. We recommend lifestyle changes, encouraging exercise, weight loss and reduction in salt intake, and use medications when the blood pressure stays too high. In the SPRINT trial, a comparison group was treated with blood pressure medications, sometimes 3 or more different types, to lower the systolic blood pressure below 120. The patients in the comparison group (more intensive treatment) apparently did better, with a 30% reduction in heart attacks, heart failure and stroke, and 25% reduction in risk of death.

The SPRINT study only looked at patients 50 years of age or older with other risk factors for cardiovascular disease, including heart disease, kidney disease and a calculated risk of cardiovascular events of greater than 15% in the next 10 years. The data still hasn't been released in a way that we can really understand it, and there may be important caveats, such as subgroups who have particularly better or worse outcomes with intensive management, and other beneficial or terrible effects of the interventions. The news so far is just in the form of a press release, with an actual scientific article eventually to be published.

What bothers me is that now a whole group of people who think they are actually well will be encouraged to take medicine, with associated significant side effects, and will identify themselves as vaguely sick and needing medical attention. Also those patients who already are treated for hypertension and have "good control" will be started on yet more medications with drug interactions, high costs and potentially dangerous side effects. It will be difficult to lower the blood pressure below a systolic of 120 without causing symptoms of dizziness and fainting in some patients, and there will be an increase in the number of doctors "failing" to treat high blood pressure adequately and patients "failing" medications.

Already, at our present definition of high blood pressure (hypertension) one in three adults has it. Three out of 4 patients 75 years of age or older has hypertension. The CDC (Centers for Disease Conrol) estimates that treating hypertension costs over $46 billion per year. According to data from various randomized trials, at least 100 people must take blood pressure medications for 5 years to avoid 1 heart attack. This number varies significantly depending on a person's age and overall risk for heart disease, so more than 500 fifty year old women must be treated for 5 years with anti-hypertensive medications to avoid a heart attack, whereas 65 year old men can expect more of a benefit, with a "number needed to treat" of 101. If we lower the target blood pressure to 120, essentially every adult, with a few exceptions, will be on pills for their blood pressure, and the vast majority of them will see no benefit.

The side effects of treating high blood pressure, besides the cost of medications and doctor visits, which aren't trivial, include life threatening electrolyte imbalances, kidney failure and facial swelling as well as annoying dizziness, swelling of the feet and a cough. A sizable portion of the people who are treated with blood pressure medications, or would be, will experience side effects and no actual benefits.

Treating everyone with an elevated blood pressure with medications and defining them as having a medical condition was a huge expansion of the scope of medical care. The first effective anti-hypertensive medications were released in about 1958 and now there are hundreds of them, varying in mechanism, price and effectiveness. Hypertension was really the first symptom-free condition to be widely treated and marked a transition in doctors' roles to include more care that was focused on preventing actual disease than treating it. Most of us like the sound of that, but it means that one in three adults "needs" a doctor for their hypertension, and if hypertension is redefined at a lower number, virtually everyone will be under medical care.

There is a complex interplay of values going on here, and it is strongly influenced by the fact that medicine, as an economic entity, successfully markets itself and expands its markets by identifying conditions that increase risk for actual misery. These conditions then become targets for treatment, which increases doctor visits and medications prescribed. Treating high blood pressure has been perfect in this regard because the need is real in many cases and the outcomes have often been gratifying. People with significantly elevated blood pressure, especially those in whom it is persistent, do develop devastating strokes, heart attacks and kidney failure and treatment to lower the blood pressure, if taken regularly and over long periods of time, really does reduce their risk. Still, vast numbers of people are treated for high blood pressure who experience high costs, significant side effects and medicalization with no benefits, at huge costs to society in general.

Research shows that the vast majority of blood pressure measurements are taken in such a way that blood pressures may be artificially elevated. One way to narrow the scope of treatment would be to measure blood pressure more accurately--either by actually having patients rest for 5 minutes before taking blood pressures or by using ambulatory monitors which take blood pressure throughout the day during a person's regular activities. Both of these methods would serve to focus our efforts on people who might actually benefit from them.

What would be a good direction to move with treatment of hypertension that would help reduce overtreatment and increase benefits of treatment? Research focused on truly identifying who needs antihypertensive medication would be great. If 500 people like me need to be treated for 5 years to avoid one heart attack, that means that too many people are being treated. Research could help determine which of those 500 people actually need treatment, if it was designed to answer that question. The SPRINT trial was designed in such a way that it will likely increase both the number of patients in treatment and the number of drugs prescribed. That is not what most of us want. It is, however, the kind of research that grows medicine's market share.

If the treatment of hypertension was focused on patients who would truly benefit, and the intensity of treatment was proportionally higher for those with the greatest need, quite a bit of the tens of billions of dollars spent on hypertension might be liberated. The money not spent on medications and doctor visits could go to other interventions that would reduce cardiovascular disease. The amount of money that goes into overtreatment of hypertension could buy cooking classes and exercise rooms, swimming pools and dance classes. Unlike doctor visits and medications, this type of preventive medicine also makes us happier and helps make our lives richer.





Monday, August 17, 2015

Medicare Part D--the insurance plan to cover medication for seniors: has it helped?

In 2003 the Medicare Modernization Act added a prescription drug plan to the benefits available to seniors and disabled adults. The act did a few other things, including introducing health savings accounts and defining Medicare Advantage Plans. The prescription drug plan rolled out in 2006, after which time seniors who bought the extra coverage had some help paying for their ever more expensive drugs. Today the government pays about $70 billion per year to provide this service, 11% of the total cost of Medicare.

The purpose of Medicare Part D was to allow seniors, often the most financially vulnerable of our patients, to be able to afford to pay for medications without impoverishing themselves. Since medications are such an important part of treating the diseases of aging, the government hoped that seniors who were able to pay for necessary medications would be healthier, requiring fewer hospitalizations and emergency room visits. This improvement seemed likely to, at least partially, offset the costs of the program.

Medicare Part D is a private insurance plan which costs the insured, on average, $30 a month and pays some or all of the costs of prescription drugs, depending on how expensive they are. Different plans are different, but most stop paying after having paid out $2970, but will pay all but a small amount once the patient's out of pocket costs exceed $4750. The period of time during which the patient must pay all of their drug costs is called, euphemistically,  the "donut hole." Since the total cost of medications is not covered by the premiums people pay, Medicare subsidizes the difference.

In June, the Annals of Internal Medicine published an article which looked at the health benefits experienced by patients on Medicare due to Part D. They were unable to detect any improvement in health or utilization of hospital or emergency room services in Medicare recipients after the initiation of part D in 2006. They did find, however, a 14% increase in the use of prescription drugs. The study certainly would not be able to detect the fact that some seniors certainly did benefit by being able to afford life-saving medications, but on the level of the total population of patients on Medicare, there was no evidence that Part D improved health.

In some ways, Part D coverage is wonderful, despite this study's results. It is definitely less common, since its inception in 2006, to see older people stopping their medications because they can't pay for them. It is also less common for patients to have to choose between having money for food or doctors' appointments and paying for prescriptions. Sometimes I find that, because of the occasionally wonderful oddities of insurance, Medicare insured patients can actually afford the newest and best drug that truly has a positive impact on their lives.The ability to take a drug with a more convenient dosing schedule or with fewer side effects may not keep a patient out of the hospital but it can surely improve their quality of life. Having to stop a medication because of the "donut hole" coverage gap can lead to emergency room visits or hospitalizations, however. A much more expensive Part D without a "donut hole" might have a more impressive outcome.

On the other hand, however, prescription drug coverage that leads to a 14% higher utilization of medications might very well lead to worse health outcomes, which could help explain the findings of this study. In the years since Part D was rolled out, there has been a huge increase in the amounts of opiate pain medications prescribed, and many of the patients who use these are seniors. The epidemic of chronic prescription opiate use and abuse often reduces older peoples' ability to get around and increases falls. Other prescription drugs, even those felt to be pretty much harmless, often have interactions that are much more prominent in bodies that are aging. Side effects are also more common as we age, and can be devastating. Being able to afford more drugs undoubtedly can increase the risk of hospitalization, emergency room visits and disability in a significant subset of patients on Medicare.

When Medicare Part D was adopted it was clear that it benefited the pharmaceutical industry. It was expected, however, to be a win/win situation, with newly insured patients healthier as a result of their improved access to medications. The bill included the requirement that the government not be able to negotiate drug prices with drug companies, which the Veteran's Administration is allowed to do. This results in considerably higher costs for drugs for Medicare recipients than for VA insured patients. So Part D is expensive, and is probably considerably more expensive than it needs to be. People do like being able to get any medication prescribed or recommended by their physician, which is a limitation in a system like the VA's where there is a pretty set and pretty narrow formulary of drugs available. But formularies don't define which medication a patient can take, only which one will be provided at low cost by the dispenser. Negotiating prices within Medicare Part D, with an associated formulary could still allow choice and probably save lots of money.

Does Medicare Part D prescription drug coverage help? It depends on the patient. It clearly does help the person on a fixed budget who finds him or herself in need of  several medications which might add up to a few hundred dollars a month or more. A healthy but not wealthy 70 year old might have a sudden heart attack and find that he has diabetes which he had known nothing about having not visited a doctor for years. That patient might well be discharged from the hospital on 6 new medications which would throw his budget into an uproar, but might well keep him in good health for years. For patients with fewer needs or more abundant income, prescription drug coverage may do no good at all. For some patients whose ability to afford medications means that they will take ones which adversely affect their health, Part D is a hazard. Certainly 70 billion dollars a year and 11% of the healthcare budget is pretty pricey. The Medicare drug benefit probably needs a major overhaul in light of the data that it does not appear to have a significant or cost saving health impact on the population.