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Thursday, December 8, 2016

Drugs for cholesterol and high blood pressure actually can be cheap and work

A couple of weeks ago I started taking medicine to lower my blood pressure and another to reduce my cholesterol. This was a controversial move, given my deep distrust of the practice of medicine, when it is practiced on me, and pharmaceuticals in particular.

I know that, as a woman of 55 with an very active and healthy lifestyle, no chronic diseases and most importantly as a nonsmoker, I am at very low risk for any of the conditions that high blood pressure or high cholesterol could cause to happen. I am unlikely to have a stroke or a heart attack, develop narrowing of the arteries to my legs or develop kidney failure. The blood pressure and cholesterol levels have no effect at all on how healthy I feel. But one day, while pointing an ultrasound probe at my own neck, I saw a small plaque (a thickened area) in my left carotid artery. It was very calcified, which meant that it had been there a long while, but my carotid was not pristine. It is undeniable: I have vascular disease.

Will this lead to a stroke? Does it imply that the arteries around my heart are also affected? I don't know, and I may not find out. But I do know that taking a cholesterol lowering drug helps reduce heart attacks in patients with vascular disease around their hearts and I extrapolate that it may help reduce further changes to my carotid arteries which might lead to a stroke. My blood pressure is a bit high, and bringing blood pressure down does reduce stroke risk. I don't know that it will reduce my stroke risk, however.

So it was not entirely clear that I should take either cholesterol or high blood pressure medication. A little reduction in my very low risk may not be worth taking a medication with potentially profound side effects and associated high costs.

I decided to try the medication in order to assess whether it gave me trouble of any kind. If it did not, I might have nothing to lose. The blood pressure medication, lisinopril, has been on the market for decades. It is strongly associated with reduction in the usual complications of hypertension. Its main side effects are a nasty nagging cough and dizziness. It can also cause life threatening swelling, often of the face, but this is rare. I have had no swelling, no dizziness, and though I can feel just the tiniest bit of increased tickle in my lungs, it is hardly noticeable.

Regarding the cholesterol medication, atorvastatin (formerly known as Lipitor), it, too, has been around for a long time and has been extensively tested and found to be pretty safe and effective. It can cause muscle cramps and weakness, and I have been told by some patients that it makes them less mentally acute. It can cause gastrointestinal upset and may be associated with weight gain and a risk for diabetes. I am having no trouble so far.

As for the cost, I have had to shell out nearly $5 in copays each month, with my insurance footing about $1 of the bill. This is not expensive. This is a superb deal. I get it from my local pharmacist, not even from a mail order or Walmart's $4 plan. It is cheaper than Walmart's $4 plan! In 20 years I will have spent around $1200, plus there will be the occasional blood tests to monitor my kidney function. I checked my cholesterol after being on it shy of 2 weeks, and it was dramatically lower. I, once again, am not sure that this will translate into better health, but it is not odious at all.

The moral of this blog is that not everything is terrible in the US healthcare system. I could, and will, complain about the surrounding process that leads to people like me being on medicine at all, including issues like medicalization of the healthy and blockbuster drugs being widely adopted without adequate scrutiny, but presently I will give generic atorvastatin and lisinopril a big high five.

Friday, November 18, 2016

Presidential Election 2016 and the internet--the real winner

The last year has been difficult to watch, and the last few months even more so. News and quasi-news organizations have been bombarding my email with stories about the people vying for our presidency. It has been anywhere from difficult to completely impossible to screen this information for accuracy. Lies and information taken out of context and repeated until it seems true has been part of both party's rhetoric. The whole field of potential candidates were infected with it before the primary elections.

The emotions have been high, too. By the time the election finally happened on November 8th, we had a comic book villain straight out of the Batman movies running against Satan in female form. The outcome has left people deeply sad and frightened, even people who voted for the winner. There is hope, too, and kindness and gathering together. There is huge uncertainty.

I've been alive for 13 presidential elections, and this one was really different. This is partly because of an increasing gap between rich and poor, fallout of the financial crisis of 2008 and the changing international landscape, but the biggest change has been the growth of our use of the internet and social media.

Most people like to believe that the reason for our recent presidential election results can be found in the thoughts and behaviors of human beings. It feels good, in the face of a frightening and unexpected event to imagine a way that it could have been under our control, that next time we could anticipate it and make significant changes.

As human civilization has evolved, so has our ability to communicate complex ideas. Language, then writing, then printing presses, then telegraph, radio, television and now the internet, links us and allows us to learn from each other and share ideas and feelings and events. With the internet, and now our mobile phones which are ridiculously powerful computers in our pockets, we nearly share a common brain. Even the progressively smaller portion of the population that isn't directly connected via a computer is indirectly connected if they read a newspaper, watch a TV or even talk to a neighbor.

The internet of news is a small part of the entity that is the entire internet. Items that people like to look at rise to the top of any search and appear prominently on Facebook or other sites where people share information. This could be a cute baby dancing, a way to lose weight or a delicious news story, such as a powerful person behaving poorly and getting caught. We will choose to look at these things even if they are out of context, don't work or aren't true, and they will become a larger proportion of what we see. We will be less likely to look at things that are complex, nuanced, and present more than one side of an issue. What we click on is what we get.

There is actually quite a market in made to order "news". Paul Horner was featured in the Washington Post, explaining that the lies he successfully spread via Facebook and other sites around the elections were really just satire and made to be taken as such. But readers believed that people were being recruited and paid $3500 to protest at Donald Trump rallies (he invented this and even created a fake Craigslist advertisement to back it up.) He made money on stories like this, and others such as that the Amish had decided to vote for Trump. Ads on these fake news sites make a good salary for a person with a good imagination. I won't link the stories because that would, in a small way, add to the viral nature of the stories and Paul Horner's livelihood. In fact, by posting a link to the Washington Post article, which links to Paul Horner's stories and his ads, I have contributed to his success, and perhaps the success of fake news in creating misguided popular sentiment.

Humans are amazing. We have created a way to communicate instantly with a group of friends on opposite sides of the earth. But with this we have power to make fiction nearly real, with potentially disastrous consequences. On the medical side of things, I have noticed that the ability to be completely absorbed in communication that requires nothing but small movements of the hands has contributed to an epidemic of diabetes and obesity. Although entertainment that doesn't require the use of resources may be an important aspect of life in a resource stressed world, I don't think we are ready for what we have created. We are more than what we have let ourselves become. We have abilities to connect via touch and smell and eye contact. We care for each other deeply. We have let ourselves become communication nodes made of flesh in a supercomputer which does not have our best interests in mind.

Personally I am being a bit childish about all of this. The internet has let me down. It has sucked up my free time and made my patients fat and has elected people to the country's highest office based at least significantly on information which is not true. I read that we need to take to social media to unite to fight for causes I believe in, and I am questioning that. Facebook is no longer on my phone. I think several times before clicking on links. And I realize that this is a piddly and ineffective response to a problem that is huge and unacceptable. There has been tremendous good that has come out of our ever more powerful abilities to communicate, but presently I am very angry at the internet and I refuse to play.

Monday, November 7, 2016

Suicide, psychiatric care and inadequate resources

An article released today in the JAMA sites evidence that the suicide rate in America has risen by 24% in the last 15 years associated with a significant reduction in the numbers of psychiatric beds available. The US has had a lower capacity for psychiatric patients than comparable countries in Europe for years, but in between 1998 and 2013 that number dropped even further.

Waiting in the ER for days
This trend has resulted in atrocious treatment for people with mental illness. Because it is so difficult to find room in a mental hospital for patients with mental conditions that make it unsafe for them to return home, such as suicidal thoughts or intentions, we sometimes see these people spend days or even weeks in emergency rooms just waiting for something to open up. I never saw this a decade ago, but now it is not uncommon, even in our small critical access hospital, to see a patient in one of the little windowless and noisy cubicles of our ER for days at a time. They can't move upstairs to a more comfortable, if inappropriate, hospital bed because our hospital cannot offer psychiatric hospitalization because we have no psychiatrist on staff. Psychiatrists are rare in small towns.

Many factors led up to this
This situation is a slow motion car wreck, not an all of a sudden sort of thing. Care for people with mental illness has been spotty and often terrible in the US, but has generally had a trajectory that aims toward better care and understanding. Early in the 19th century an approach called "institutionalization" created mental hospitals which were intended to care for people with what was then untreatable mental illness for long periods of time. These institutions fostered dependence, usually did not cure or treat psychiatric disorders, made patients vulnerable to abuse and, to top it all off, were quite expensive. Some of the costs were defrayed by unpaid work required of inmates, but in 1973 a court ruled that they were owed at least minimum wage, making the overcrowded and expensive institutions even less viable. Starting in the 1960's a strong movement, led by mental health pioneers, pushed for deinstitutionalization. It was argued that most mental patients could have their needs met by community mental health centers and could live in sheltered living situations such as halfway houses. Many state mental hospitals were closed in the 1970's and 1980's, with good and bad results. The number of severely mentally ill people who are homeless did increase significantly, putting a higher burden on already stressed acute care hospitals. Drug therapy for depression, bipolar disorder and schizophrenia began to be more effective, though, which meant that some people with these diseases genuinely got better and were able to be successfully independent.

Medical insurance and mental health
There was less capacity for inpatient care of mental patients after deinstitutionalization, but for many of these people any care at all was prohibitively expensive because most insurance plans had little or no coverage for mental health issues. In 1996 the Mental Health Parity Act was passed which required health insurance companies to cover mental health costs up to the same dollar amount as covered for medical or surgical care. Insurance companies quickly circumvented this by restricting numbers of visits and numbers of days in the hospital. In 2008, as the real estate market, banks and stock market were going up in flames, a rider was placed on TARP (Troubled Asset Relief Program--otherwise known as the bank bailout) called the Mental Health Parity and Addiction Equity Act. This was worded in such a way that mental health care is now generally covered by insurance.

It is wonderful that people with depression, schizophrenia, bipolar disorder and other serious mental illness can get help without necessarily bankrupting their families. This can mean that people get treatment for these problems before they get serious enough to require hospitalization. It probably also increases the demand for psychiatrists and psychiatric beds, both of which are in short supply.

The American psychiatrist: an endangered species
Psychiatry is not a very popular specialty. Out of about 30,000 residency positions each year, only 211 were for psychiatry in 2014-15. That would translate to 211 new psychiatrists for the whole US the year they complete training, assuming all of those candidates finish the program and choose to practice in the field. Many psychiatrists are aging and retiring and there is already a critical shortage of psychiatrists to meet our present needs. Psychiatry is one of the lower paid medical specialties and is a difficult row to hoe. Successful treatment of patients is very dependent on variables over which a psychiatrist has no control, such as community support, housing and job programs.

Prisons: our new insane asylums
Prisons now house a tremendous number of people with mental illness. In 2007 the Department of Justice reported that 24% of jail inmates had symptoms of psychosis, about a quarter of people in jails and prisons had a history of mental illness and a higher percentage had symptoms of mania and depression. The total number of patients in state mental hospitals is about 35,000 and the number or mentally ill people in prison is over 10 times that number. It is very difficult for people dealing with mental problems to tolerate the stresses of incarceration, leading to high rates of injury in fights and attempted suicide.

But people with mental disorders who are at risk for injuring others or breaking the law are more likely to get a bed in a psychiatric facility than people who are simply miserable or increasingly psychotic and have not broken the law, who could really benefit from a stay in a psychiatric hospital to stabilize their medication and give them intensive treatment. It is those miserable, suicidal and psychotic to the point of inability to care for themselves people who end up in emergency rooms for days awaiting a bed.

What would it be like...
I can only imagine how it feels to be seriously mentally ill in some of these situations. Picture being seriously depressed or anxious and being in prison, where kind words are mostly non-existent and there is nowhere to take comfort. Or schizophrenic, hearing voices that break you down, surrounded by nobody who cares. I can hardly allow myself to conceive of depression, anxiety or psychosis while homeless, exposed to the rain and the cold and vulnerable to assault. Closer to home are the patients who wait in the emergency rooms, with nothing to do, no chance to go outside, take a walk, lying on a 30 inch wide gurney covered with rumpled sheets, contemplating suicide while having no idea what is happening and when.

If we were to fix this, what steps would we need to take?

Clearly we need more psychiatrists. We also need more psychologists and they need more authority to treat, including with medications. This is a different conversation, with intrigue that I don't really understand. But we do need psychiatrists, MD trained, motivated, excellent at what they do, and we need to pay them in accordance with how vital their work is. There are already incentive programs to train as a psychiatrist and work in underserved areas, but we need more incentives.

We need more capacity to take care of patients in hospitals, for those times when things get too intense for them to survive independently.

We need systems to help take care of people with mental illness who need jobs and housing and treatment for substance abuse. We need to strengthen social networks in neighborhoods and communities. This is vitally important for keeping patients out of psychiatric hospitals and out of prison.

We need to shift people with mental illness out of the prisons, which are overcrowded, overused and dysfunctional. This will involve better and more capable staffing and better oversight along with more capacity to take care of them in psychiatric hospitals and community mental health facilities.

We need to support the families of these patients because they are often the only stable thing in their lives. Patients with mental illnesses often burn out their families which is a tragedy in so many ways. Programs to support families, including caregivers and assistants to help support patients' independence should be strengthened.

All of this will cost money, but I suspect not more money than we are presently spending on our dysfunctional systems. Shifting money towards appropriate care for people with mental health problems will not only reduce costs that go to warehousing many of them in the prison system and the cost of acute medical care for the homeless and those plagued with addiction, it might also decrease the overall national burden of misery, hopelessness and isolation.

Thursday, November 3, 2016

Recovering--a sacred time.

One day a few weeks ago, after returning from a set of seven 12 hour shifts in a hospital away from home, my husband convinced me to go to a concert. The group performing was the Deviant Septet, based out of Brooklyn, NY. They were an odd combination of instruments and they played mostly newly composed music.

The second piece in their program was by Chris Cerrone and was called "Recovering." I expected nothing, perhaps a nap even, but was completely absorbed by the music which wordlessly represented a magical period that I get to observe regularly but rarely remark upon.

Patients come in to the hospital when they are sick, and often getting sicker. They are vulnerable and place themselves in the hands of strangers. Usually they feel terrible. We do things to them to try to make them better. Often we are successful. And then something magical happens. Their faces look brighter. Their vital signs stabilize. Their eyes focus. They make jokes. It's still not over, though. There are setbacks. There is pain. They are weak and their appetites are not vigorous. But a gate has been passed through.

I don't often take the time to appreciate this transition. For me it is often filled with new concerns. What next? How can we all avoid this kind of event in the future? How much more time before this person can leave the hospital?

This piece of music took me back to the times when I was sick and finally getting better, when the world around me began to be relevant again, and sometimes beautiful. It reminded me that there is a thing that happens, this "recovering", and spending a little time noticing it will be a good practice.

Saturday, September 24, 2016

My week in ultrasound

After 5 years of doing bedside ultrasound, I'm still excited about it. Bedside, or Point-of-Care ultrasound is using an ultrasound machine during the physical examination of a patient in order to make a diagnosis. I use a pretty tiny machine that fits in my pocket. As an internist who works in the hospital and in rural clinic outpatient settings, I get to use my ultrasound all the time, and it's still lots of fun. (For more on adventures in ultrasound see this or this or this.) Those of you who have read this blog for awhile can skip the intro and go to the cool cases.

When I talk about it, most people who haven't already heard me wax eloquent say, "you mean you look at babies?" Ultrasound has been used as a bedside tool for looking at pregnant wombs for a very long time. It is extremely useful for that, since you can see if the baby is alive, about how old it is, whether their are two, what position it is in and a number of other useful things. I would never give up the chance to look at a baby if my patient were pregnant and willing, because they are so cute, but since I am not an obstetrician, I look mostly at other things. I can see whether the heart is failing, whether there is extra fluid in the lungs or belly, whether the kidneys are blocked, whether the bladder empties. I can see pneumonia and broken bones, tell whether a swelling is full of fluid and whether a lump is solid or a cyst. I can see disease in blood vessels and stones in gallbladders. Combined with talking to a patient and doing my usual physical exam, I can determine whether a patient is dehydrated or the opposite and can often be more accurate about diagnosing blood clots or sepsis. It's cool. Yes indeedy it is.

This week I worked as an outpatient doctor in clinic and also in the hospital, admitting and taking care of sick patients. I use the ultrasound nearly every time I examine a patient and it always helps, but there were some cases in which it was more spectacularly useful than in others.
  1. A patient in clinic had pain in her head and cheek and teeth on the right side 3 weeks after getting a cold. She had a long history of allergies and sometimes used a nose spray or an antihistamine, but this was worse than usual. On exam there were polyps in the nose and maybe a little bit of tenderness in the right side of her face. It is possible to use the ultrasound on the sinus bones behind the cheek to see if there is fluid, because fluid transmits ultrasound and you can see the back wall of the sinus only if there is fluid in it. I could see the back wall on the right, the side with symptoms and not on the left. I diagnosed a sinus infection. She will try nasal steroid spray and washes to see if things can open up and drain, and if that doesn't work, she has a "pocket prescription" for an antibiotic which she can fill and take. I also looked at the teeth on the right with the ultrasound and found no evidence of an abscess, which was reassuring.
  2. Another patient in clinic had stubbed his toe pretty hard. It had swollen and then swollen some more and he was concerned about an infection. The clinic does not have an x-ray machine and is a pretty long drive to the closest one. Beside the cost, it takes an hour of a patient's time to wait, fill out papers and then have an x-ray done, plus I will usually then wait another hour for results and the patient will then be difficult to contact. I was able to ultrasound the toe, find a non-displaced fracture at the point where he was tender and give an explanation plus an appropriate set of recommendations.
  3. At the hospital I had a patient who had been admitted with low blood pressure and likely pneumonia along with blood enzyme tests suggesting a possible heart attack. He responded well to antibiotics and fluids and, due to having lots of chronic medical problems, wanted to avoid being transferred to a larger hospital to see a cardiologist. I knew from previous visits what his heart looked like with ultrasound and could tell him that it looked no worse, which meant that an emergent visit to the cardiologist was not necessary. I was able to use the ultrasound of the heart at the time of our conversation to help guide our shared decision-making about whether to get in a helicopter and head far away from family and friends.
  4. Another patient had severe pancreatitis, an inflammation of one of the nastiest and most caustic organs in the digestive system. He was 80 years old and drank too much whiskey on a daily basis, which caused the pancreas to become angry. After a day or so he developed an acute alcohol withdrawal syndrome, trying to crawl out of bed, anxious and with an elevated heart rate. We treated him for the alcohol withdrawal, but his heart rate remained elevated. Was he dehydrated? None of the other labs gave me the information I needed, but ultrasound of the inferior vena cava showed that he had been adequately hydrated and that, as expected in severe pancreatitis, there was some fluid in the belly and at the base of the lungs, so more fluid would make things worse rather than better. I was able to repeat the ultrasound daily to determine how much intravenous fluid to give.
  5. A young man, with a history of longstanding intestinal inflammation and several operations in the past, presented with abdominal pain. X-ray was pretty normal, but can be hugely misleading. A CT scan would have been helpful, but is associated with a high radiation dose. He had undergone many CT scans in his life and the possibility of his developing cancer on the basis of his radiation exposure was already significant. I was able to look for fluid in the belly or fluid filled loops of bowel which would suggest obstruction and feel pretty confident that a non-surgical approach to his problem was safe. 
It was a good week. Nobody died. I felt competent. Patients were happy. Bedside ultrasound was terrific.

Sunday, September 18, 2016

What's wrong with socialized medicine? The Economist calls the National Health Service "a mess"

The British National Health Service (NHS) was born in 1948, based on legislation passed that year mandating free high quality healthcare for all paid by taxes. In contrast, the US started Medicare in 1966 to provide healthcare to the elderly and the State Children's Insurance Program (SCHIP) in 1993 to fund healthcare for children whose parents were unable to afford it. Healthcare in the UK is still almost entirely funded by the government (through taxes, of course), which it is not in the USA.

Britain is proud of the NHS, and rightly so. They have it figured out. Or so it would seem. Everyone can get care and nobody goes bankrupt because of huge medical bills. Brits do have to pay for prescriptions but everything costs the same, the equivalent of $11 per month.

So why would the Economist, the global news magazine based in London, call it a mess? This article says that the NHS is in trouble, and needs to learn some new tricks in order to stay effective. It turns out that Britain only spends 7.3% of its gross domestic product on healthcare which is significantly below average for its peers in the Organization for Economic Cooperation and Development (OECD) countries, and plans to cut that expenditure to 6.6% in the next year. Because their population, like ours, is aging, costs of care are actually rising so already pinched services are being further curtailed. Because of the high costs of caring for patients with complications, some local health commissions will not provide routine surgery to patients who are obese or smoke cigarettes. General practitioners are overworked and can't provide the kind of preventive services that keep patients out of the hospital and nursing homes are unable to house all of the patients who need their beds so those patients stay in the hospital, limiting the beds available for sick people or people needing surgery.

The US, in comparison, spends over 17% of its GDP on healthcare, at least 5% more than the next highest OECD country. Most of our problems are not due to stinginess of payers, but rather to distribution of healthcare dollars, with some people having no access to affordable medical services and others receiving care that is very expensive which they may not need or want. Many of us long for a fully government funded healthcare system like the NHS.

So what has gone wrong with the NHS, then? I'm not entirely sure, but I have some ideas. Since the government is the payer for services, they have the ability to limit funding. Because of the inevitable waste that goes on with the provision of medical services, it could well be that 6.6% of GDP is plenty to provide good healthcare. It is not enough right now with the system they have. Because the government pays for services regardless of whether the consumers find them to be of good quality, there is no direct incentive to please the patient. Because doctors don't know how much things cost, they are less able to be good stewards of resources. Their healthcare delivery is therefore inefficient, and reducing funding has not made it better.

We do have similar problems in the US, with both lack of knowledge about what things cost and lack of incentive to do things better or more efficiently. Because the government is not the only payer and so cannot put a cap on payment for healthcare, our system is much more expensive. Our hospitals are prettier and our technology is more snazzy and we probably do more miracle cures per capita.  But citizens of the UK have universal access to medical care and nobody goes bankrupt because of medical bills.

Since healthcare per the NHS is not what we want, but we do want universal access with good quality and lower costs, how shall we do it? Americans have enough mistrust of government, and fiscal conservatives are absolutely allergic to the federal government being the sole provider of health insurance, so we will not get "socialized medicine" anytime soon. The Affordable Care Act (ACA, also known as Obamacare) has improved our situation considerably. Expanding Medicaid to cover Americans whose income is at or below 138% of the federal poverty line has helped in the 31 states that have adopted that (my state, alas, is not one of them.) It is now easier and cheaper for the rest of us to get insurance, which helps avoid catastrophic and crushing medical bills. But even people with health insurance go bankrupt due to their share of healthcare costs, combined with inability to work. Footing part of our medical costs is supposed to help us make more frugal decisions, which is one of the reasons most healthcare proposals have included some kind of a deductible ("cost sharing.") Unfortunately most patients don't have the information they need to make frugal decisions and their doctors don't know enough about costs or other options in many cases to help them do this.

In the JAMA (Journal of the American Medical Association) an article reported that an intervention to give doctors information on costs of the various aspects of their patients' care as well as a look at their outcomes significantly reduced costs while improving hospitalized patients' health. This seems obvious. Of course knowing what things cost and how a patient fares will make us do a better job and not cost so much. The strange thing is that this is not standard practice. We don't know what the tests and procedures we order actually cost. And most of us don't get a longitudinal view of how a patients illness or surgery actually turned out.

So if we could have any system at all, what would be best for us here in the USA? I'm not sure it actually matters, as long as we get what we need and so long as there is enough shared knowledge about what things cost, how well they work and what are the alternatives. The direction we have gone, with private and government funded insurance has lead to our present situation. But if the insurance companies paid physicians to take care of patients, and how much we actually made depended on providing the most appropriate care that caused the least unpleasant impact on patients' lives, costs would go down and care would improve. This would require that patients' voices be heard. It would require that doctors knew what was good value and the healthcare industry was encouraged to create options with better value. A single government payer could do this, but not without built in systems to feedback what patients value and what actually works and innovate actively to improve quality.

Thursday, September 8, 2016

T-mobile and medical billing nightmares--a rant

A few months ago I had a clever idea about how my husband could use my cell phone in England, because getting cell phone service across the Atlantic can be expensive and inconvenient.  

So I had this bright idea. I have an unlocked smartphone that I use in Africa or Haiti with a sim card that I can buy there cheaply and with no difficulty. T-mobile, the cellular phone provider that began as a German company and has provided competitive service in the US, advertised that their service would also work in the UK and Europe and that it would include unlimited data. Or something like that. It sounded great. I would just buy the T-mobile sim card in the drugstore here, get the service and be good to go. But not so fast. T-mobile does have the no fuss pre-paid option, but to get the international service requires a different plan, with a monthly fee. After attempting to do this online, then converting to the monthly service, nearly losing the money I had mistakenly spent on prepaid minutes, speaking to operators working out of many non-English speaking countries, whining and finally prevailing, I signed up. Unfortunately T-mobile didn't work in most of the places my husband traveled and didn't work at all in my community. No big deal, live and learn, and I never received a bill. Cool. It didn't work and I didn't have to pay. Eventually they notified me that my service had been discontinued. All good.

Then I got a notice that my account had been sent to collections. $185.00 I owed. I called, spoke to people from many countries, raised my voice, heard vile hold music, spent an hour predominantly on hold, closed my account, and assured the poor folks at the call center that I didn't intend to pay for a service that had never worked and for which I had never been billed. As I delved more deeply into what had happened, I found that they had notified me of billing, via the cell phone that had no service where I was. When I tried to log in to my account at their website to look at an itemized bill, I no longer had access due to having closed my account. I fumed and felt myself to be ill used. At last I paid the bill in order to never have to speak to them again or listen to their hideously distorted hold music. Probably worth it. I will think of it as a fine for making a poor choice. I did research other customer complaints regarding T-mobile and found that mine paled in comparison. It could have been so much worse.

But the whole experience did make me much more viscerally aware of how my industry treats people who owe money. I consider T-mobile to be a bunch of amoral and powerful extortionists. But the same kind of thing happens to thousands of unsuspecting medical consumers when they unwittingly spend huge amounts of money on medical care. Take, for instance, a person hit by a car. Insured or not, they will be billed for some portion of their medical care in emergency rooms, surgery, intensive care and for their general medical hospitalization. As they lie helpless in the hospital the bills will likely arrive at a mailbox that is being emptied and put in a shoebox by a neighbor, possibly under a utilities bill that is more important or likely lost amid catalogs, and certainly confusing as heck once they are opened. Hospitals and doctors are not shy at all about sending unpaid bills to collections. When the unfortunate car accident victim finally gets home after rehab, the collections agency will likely have reduced the information in the bill to a single heart-stopping number without any itemization or information about how to dispute it (such was my T-mobile experience.) The Consumer Financial Protection Bureau documented in a December 2014 report that just this sort of thing happens frequently due to the complexity of medical billing and insurance payments. People sent to collections for medical bills often have completely clean credit histories and didn’t pay those bills because it was never quite clear who owed what and to whom. (For more info on medical billing, read this blog.)

I can choose never to deal with T-mobile again if I want. Also my bill was only $185, which is a lot for nothing, but will not bankrupt me. Medical debt is the major cause of personal bankruptcy and a decision to never receive medical care again can have devastating consequences. Sometimes, as a person who is supported by healthcare dollars obtained in part from heinous billing practices, I wonder if I'm really one of the good guys.
(I would like to see a system in which medical care cannot destroy a person financially. This will involve reducing what we spend on it by getting rid of wasteful practices that do nobody any good, simplifying the payment system and assuring universal access to what we can agree are necessary medical services. But that is a story for another day…)

Tuesday, July 26, 2016

The "Yearly Physical"

"I'm going to the doctor next week for my yearly physical."

So normal. Of course you are. Everyone should do that.

But the concept of a yearly examination of one's whole body to see if everything checks out fine is a relatively new invention and whether or not it is necessary is a very controversial question.

I just read an article by Abraham Verghese, an internist and champion of physical diagnosis, professor at Stanford University, inspired writer, about the history of the physical exam. The idea that physicians could know more about a person than he or she could know about him or herself has only gained traction in the last century and comes partly from the invention of gadgets such as the stethoscope, the reflex hammer and the blood pressure cuff which reveal truths only to those of us skilled in their use. Enthusiasm for these has waned a bit as we have become enamored of our ability to see the shadows made by bones and such during an onslaught of electrons (x-rays), or the ability to check the levels of molecules and minerals in the fluids of our bodies, among other technological miracles. This evolution which takes us away from the bedside has also made us less confident in and also less dependent on the information we get by physically examining our patients.

We love what we can measure and correlate, and the physical exam is part of that process. If we can feel an enlarged spleen or liver, that is correlated with certain disease states, but certainly not always. If we can feel lumps in the breasts, testicles or thyroid, there may be something life threatening going on. Or not.

As doctors, we are trained in the nuances of the physical exam. I learned how to examine every orifice and surface, looking for specific abnormalities, and then developed skills over many years in understanding the wide variation in normal people. My physical exam is a conversation with my patient's body which happens simultaneously with a verbal conversation, which in itself is a kind of physical examination. How a person speaks, what interests them, how they follow the conversation are part of the neurological and psychiatric examination. As the physical exam unfolds, my understanding of a patient and my relationship with him or her deepens.

Does a physical exam save lives? I'm not sure. The definitive study will never be done. Only a small subset of what we do at the time of a physical exam has been rigorously studied and found to be of benefit. What a physical exam should entail has never been adequately worked out and there is no consensus. A pelvic and rectal exam, synonymous for some people with a "complete physical" have not been shown to have value in a patient with no symptoms in those areas. These and other parts of a "routine physical" may lead to overdiagnosis: finding something wrong that leads to more testing or treatment that does not improve or lengthen life. Nevertheless, it seems likely that a physical exam, done well and mindfully, is substantially valuable.

If it is valuable, shouldn't we all be getting one, yearly at least? Not necessarily. Plenty of people are healthy and will remain healthy without a doctor doing anything at all to them. "Health checks" were studied by the Cochrane Collaboration and found not to improve morbidity or mortality. There are a few things that would be good to check if you are feeling healthy, just to make sure all is well, though.  It would be good to measure blood pressure  or screen for HIV or hepatitis C for people at risk. If a patient somehow hasn't heard that it is unhealthy to smoke and be inactive and morbidly obese, ride a motorcycle without a helmet or drink and drive, it may make sense to impart this wisdom.

Medicare does not cover a general physical in the sense that most people think of it. What it does cover is a "Welcome to Medicare Physical" right after becoming insured under Medicare, which involves some screening that is important for determining risks and needs, and a yearly "Wellness Visit" which involves only vital signs and some screening tests along with advice on what is presently being recommended, stuff like mammograms, pap smears and colonoscopies. Patients are often put off by this because they don't like scripted interactions with their doctors, and doctors are put off by it because we have usually not memorized the script and some of us are not sure we agree with it.

Is a physical exam a good idea then? And should it be performed yearly on everyone? I, personally, would prefer that I have a chance to have unstructured time to physically examine and interview my patients yearly, in other words to do a physical. I would like them also to get information about what the evidence says about various screening tests and I would like that to be easily accessible in the medical record, but I don't necessarily feel strongly about being the person to offer that information. Perhaps a nurse or a health educator could do that better. I recognize that insurance companies may not cover a complete exam for a person who is healthy.  For this reason, a physical exam may need to be scheduled as a prolonged visit to discuss multiple health issues. Taken as a whole, and not because it is based in scientific evidence, I favor the physical exam. I also would completely forgive anyone who preferred to skip it.

Tuesday, July 19, 2016

Preventing Cervical Cancer in Tanzania

I visited Tanzania again this summer, once again helping a group of amazing University of California, Irvine medical students with their summer not-a-vacation trip to teach bedside ultrasound and do other research projects. 
One of the projects this year sprung out of a request by a doctor we have worked with on Ukerewe Island. The island he serves is rural, primarily supported by fishing, and has a high rate of sexually transmitted diseases due to fishermen visiting prostitutes on the mainland and bringing home infections to their wives and girlfriends. This translates to high rates of HIV infection, pelvic inflammatory disease and the spectrum of disease caused by human papillomavirus (HPV). HPV can cause genital warts, which are only mildly distressing, but it can also set in motion cellular changes of the cervix that can lead to cervical cancer. Tanzania has a distressingly high incidence and death rate from cervical cancer and this Tanzanian physician asked one of the students if we could do a project that would help reduce cervical cancer.

The high mortality and incidence of cervical cancer in sub-Saharan Africa can be (and has been) addressed in many ways. Primary prevention would involve using condoms or maintaining celibacy or reliable monogamy. We have a vaccine now that can prevent persistent infection, but it is still very expensive and not used much in resource poor countries like Tanzania. Pap testing is the method we use in the US to prevent cervical cancer, and its use is widespread and effective here. It involves taking a sample of the cells of the cervix during a speculum exam, sending this to a pathologist for evaluation, and repeating that test at regular intervals. Abnormal pap tests are reported to the patient who is notified to return for further testing and eventually removal of the infected tissue if it persists. The abnormal tissue is visualized by applying acetic acid to the skin of the cervix, then using a cervical microscope or colposcope to either biopsy, cut or freeze away abnormal tissue. In most of Africa this is not even vaguely practical since women go to the doctor infrequently and speculum exams are not often performed. It is not always practical to contact people by phone, and they often come from far enough away that returning for multiple visits to deal with an abnormal pap is not likely to happen. In addition, were physicians to start performing regular pap testing, there are not enough pathologists to process the specimens.

About 10 years ago I read an article in one of the large medical journals which described an abbreviated screening test for HPV infection in which vinegar (acetic acid) was applied to the cervix, abnormal areas that looked HPV infected were identified with the naked eye and those areas were simply frozen, destroying the infected and precancerous tissue. This sounded amazing. Since then this procedure has become well accepted, though certainly not universally available, to people living in many African countries. The World Health Organization has studied it and pronounced it to be practical and recommends it for resource poor settings.

The students heard about an organization, CureCervicalCancer, which teaches healthcare workers visual inspection with acetic acid (VIA) and supplies a gun which can deliver compressed carbon dioxide (available in poor countries because it is used to make soda pop) to the infected tissue of the cervix, to freeze it off.

This year several people affiliated with Cure Cervical Cancer came to Tanzania with us, trained Tanzanian MD and non-MD healthcare workers to perform visual inspection and cryotherapy and gave them supplies they would need to make the service ongoing.

The idea of being able to provide that kind of immediate and practical service was very exciting. I just thought it wouldn't work. Doctors and nurses in Tanzania are so overworked that I doubted they would come for a few days to learn a new technique. I also thought that a pelvic exam using a speculum would be a VERY hard sell for women who have never had a pelvic exam, especially since they would be feeling fine. I thought that the doctors wouldn't have time to continue to do these exams after we left. It turns out I was wrong: health care workers were enthusiastic and attended the trainings and women lined up for testing. 

The first day we had fewer patients than the leaders felt was acceptable, about 60 patients total I think. So the students who knew Tanzania from previous trips made flyers which they handed out, used their large word of mouth network and finally hired guy in a truck with a loud speaker to drive around the streets advertising the free clinic. The next two days doubled or even tripled the number of patients screened! Several cases of HPV infection were seen and treated and a few early cervical cancers were identified and referred for likely surgery.

This project may persist. They were able to train people from the city of Mwanza as well as Ukerewe Island and they promise to continue to do screening after we leave, free of charge. We shall see. There is some kind of audit planned for 6 months out. Clearly more nurses and doctors need to be trained to do this. This is clearly the right kind of screening to do in this setting and may reduce the burden of cervical cancer. In our screening clinic the host hospital also offered free HIV screening which was fantastic since treatment of HIV in Tanzania is free. Cervical cancer is more common and more aggressive in HIV infected women, so combining the screenings is really powerful.

I think this will help. I do have some reservations, though. In the US, 80% of people will be infected with HPV during their lifetimes, and the vast majority will kick it and have no ill effect. At any one time, I've read, 10% of women will have HPV infections. Only a fraction of the types of HPV that are out there are able to cause cervical cancer. The point here is that all HPV infection does not necessarily need treatment. We don't have evidence yet that VIA with cryotherapy saves lives, though it seems likely that it will and there have been mathematical models that evaluate this. VIA is, though, a sustainable method to treat HPV infection early and thus to prevent late sequelae including cancer  Clearly real prevention of infection would be the most valuable intervention in prevention of cervical cancer. This could be by vaccination, if the vaccine were affordable, or use of condoms to prevent transmission of infection.  More important even than that would be changes that allow women to have more control of what happens to them sexually. This will require improved education and economic opportunities so that women have value in the society outside of their roles as mates and mothers.

Sunday, July 10, 2016

My thyroid nodule

About 4 years ago I was examining my neck and discovered a nodule in the right side of my thyroid gland. I was examining my neck because I very rarely see a doctor and figured that I should at least cursorily examine myself to see if I could find anything of interest. My heart sounded fine, my lungs were excellent, weight was just right, pulse was nice and low, liver and spleen were fine, skin was slightly sun damaged but basically OK, blood pressure was a tad high and there was a small but definite lump in the right side of my neck.

Since I have a portable ultrasound, I looked at my thyroid nodule and found it to be about 1.8 cm, with some internal calcifications and a bright capsule. It was slightly darker than the surrounding thyroid tissue and had a few visible blood vessels.

I read about thyroid nodules and found that:

1. They are being noticed much more frequently because of increased use of CT scanning and ultrasound imaging.

2. They are very common. Nearly half of people will have significant, greater than 1 cm, thyroid nodules at autopsy.

3. About 5% of thyroid nodules are cancer, and cancer is more common in younger people, people with a family history of thyroid cancer, history of radiation to the head and neck, rapid growth of a nodule and larger nodules.

4. Experts generally recommend biopsy (taking a thin needle sample) of nodules over 1 cm in size.

5. Thyroid cancer is being overdiagnosed due to biopsies, because a needle can pick up a little bitty thyroid cancer which would never have been any problem over a person's life.

6. Some thyroid cancers will kill people. Most will not. It's hard to tell which will do what even after evaluating the tissue taken at a biopsy.

So I decided that if mine were a cancer which would cause trouble, it would almost certainly grow. I decided to follow it on ultrasound, measuring its size and watching what it looked like, and maybe get a biopsy if it grew.

It didn't seem to grow, at least not much. I was aware that it existed. I could feel it, though it didn't hurt. I was happy with my decision. Then I went to a talk about thyroid cancer at a major medical meeting. The speaker said that some thyroid cancers could grow very slowly over years and could still metastasize (spread to other areas.) Shucks. What if I got metastatic thyroid cancer? I could just imagine my family's displeasure. "It's a fool who has herself for a doctor." Also the expense, the plans forsaken. I decided to have it biopsied.

I went to a radiologist friend who said she had done many and assured me it would be painless. I scheduled it a week after my decision. I found that I needed a preoperative physical exam, which was a problem because I didn't have a doctor and hesitated to fill out my own paperwork because I figured I couldn't get away with it. So I had a physical exam which wasn't bad at all. I shuttled the paper copy to the radiology department. They still lost it, but eventually found it, and all was as it should be.

The radiology department is very familiar to me. I knew the smell and sound and paint color of the room in which I donned my hospital gown. The radiology technician gooped my neck with ultrasound gel and took about a million pictures of my nodule, measuring its length, width, height, observing its color doppler signal, looking for other nodules that might have hidden from my examining hand. My radiologist friend came in. We discussed things we agreed upon. We argued about the utility of mammography. That was probably not a good move, since she would then stick my neck with a variety of needles.

She numbed the left side of my neck with a lidocaine injection. I asked her if she knew that the nodule was on the opposite side and she reassured me that she hadn't been born yesterday and had performed this procedure before and knew exactly where my nodule was. She introduced a long needle from the wrong side of my neck into the nodule on the other side so as to avoid poking my carotid artery which was really quite close to my nodule. The bright shiny capsule turned out to be incredibly tough, requiring rather vigorous stabbing to get a sample. She then informed me that she recommended we do a core biopsy as well, since the pathologist appreciated a larger piece for evaluation. This was done through a type of coaxial cable. The core was taken with a gun which made a disconcerting thump as it removed tiny pieces of my thyroid. She showed me the little bottles with chunks of tissue it them. The hardware came out of my neck. Blood was mopped up.

It didn't hurt very much. Maybe a little like being strangled without the can't breathe part. Maybe not that bad, since I've never actually been strangled and wouldn't know. There isn't much numbing, just at the place where the needle goes into the skin because the thyroid itself has only dull pressure sensation. Swallowing is rather sore for a few days, however, because the thyroid moves up and down with every swallow.

Weeks later the bills began to arrive. I have medical insurance these days, through the hospital where I work. The total charges were $2,361. About half of this was for the ultrasound, about $300 was for the pathologist to read the slides. Another approximately $300 was to the radiologist, with free update on the utility of 3-D mammography and $500 was for supplies such as needles and coaxial cable. "Adjustments" due to using the hospital, which provides the insurance, for the whole procedure reduced the cost by a bit over $1000. So insurance paid $820 and I paid about $500.

The results came back "non-diagnostic." There was not enough thyroid tissue to be sure it's not cancer. Up to 20% of thyroid biopsies are non-diagnostic.

My initial reaction was that I was looking for cancer cells and they didn't find cancer cells and so I'm fine. It turns out that this is about right. There is a study from 2014 in which patients with non-diagnostic results on fine needle aspirate had a repeat biopsy (which I would not do because ouch, in so many ways). These patients almost never had cancer diagnosed, and almost all of those who did have abnormal repeat biopsies turned out to have false positive results. This means that they had a significant surgery removing a part of the thyroid and there was no cancer.

What I learned from my thyroid biopsy:

1. They are very expensive and the cost to even a well insured consumer is not small.
2. A thyroid biopsy is not painless. It is also not horribly painful. I do not want another one.

In the big picture, there is not a lot of value in routinely evaluating thyroid nodules with biopsy. There are 240 million adults in the US. About half of them probably have thyroid nodules greater than 1 cm. Performing an uncomplicated biopsy on all of them would cost about 240 billion dollars, assuming no repeat biopsies, diagnosing 6 million of them with cancer. Thyroidectomy and further treatment and followup of these diagnosed patients could easily cost that much again, adding up to nearly half of the US's yearly healthcare spending. A not insignificant number of people would suffer damage to their recurrent laryngeal nerve, limiting their ability to speak and sing, or lose the function of their parathyroid glands which regulate calcium balance. Of the cancers discovered, quite a few (hard to know the number) would never cause harm if untreated. Only about 1900 people die of thyroid cancer each year in the US and some of these are due to very aggressive cancers that will be fatal regardless of when or whether surgery is done. Despite an increase in detection and surgery for thyroid cancer in the last decade, there has been no change in death rates for this disease.

In the smaller picture, specifically the picture of an individual person with a lump in the thyroid, it is difficult to know what to do. Thyroid cancers can metastasize and kill a person. They just don't do that very often. Reassurance is valuable. Being diagnosed with cancer that would have caused no harm could be devastating. Being diagnosed early and avoiding death is priceless but extremely unlikely. As a doctor my practical approach should probably be to avoid searching for thyroid lumps in patients with no symptoms and to try to help those patients whose lumps come to light navigate the dangerous waters of further medical evaluation.

Thursday, June 2, 2016

Thinking beyond hospice

I recently attended the death of a friend at his home. He had a disease that was terminal and untreatable and he and his wife had finally decided on no further medical treatments that would require hospitalization. He was not very old and had been cared for by his children and wife during the previous 4 months that he couldn't care for himself. Time had become short and valuable and he had become weak, so he didn't amend his POST (Physician's Order for Scope of Treatment) to indicate that he wanted no resuscitation, though his wife and family knew his preferences. He had not entered hospice because his needs were adequately fulfilled by his family, friends, his physicians and home health.

When his wife noticed his breathing had changed, she called me, a friend of the family. I had offered to be available to come over for any medical situation in which they might need a rapid house call. I arrived about 15 minutes later and he had just died. I confirmed the situation with my medical gadgets. We were all sad and tearful and we talked and hugged and talked some more. I called the police, reported the death and the fact that it was expected. A kind and respectful sheriff's deputy came out and took a picture and a couple of statements. I called the local funeral home and a couple of guys who were on call came over with their stretcher and bag and quilt to collect him. About 90 minutes after I got the first call, his body was on its way to the funeral home and thence the earth and eventually the far corners of the universe. We sat and talked as the sun went down.

It was a good death, as much as a death of a vital and gifted person with plans can be good. It was a hospice-free home death, surrounded by family and friends. Such a thing is becoming vanishingly rare, and it made me think. Maybe we could make this easier. Maybe our community could reclaim the wisdom that it takes to facilitate better deaths, with or without hospice, nuanced to our needs and resources.

Hospice care is intended to be a holistic approach to providing support to dying patients during their last 6 months of life. The concept of hospice dates back to medieval times. Wikipedia says that in 1090 there is evidence that places existed which were devoted to care of the incurably ill, staffed by crusaders. There have been institutions for treatment of people who are dying since then, likely because of the clear need for dedicated care for people who are vulnerable and in pain and unable to advocate for themselves. Hospice at home was encouraged by Elizabeth Kubler-Ross (author of the book On Death and Dying), arguing that we shouldn't institutionalize people who are going through a universal life process. Legislation to pay for hospice care passed in the early 1980's in America. Hospice care has increased in popularity, more than doubling the number of patients utilizing the service and the amount of money spent in the last 10 years. This year an industry report predicts that the US will spend over $25 billion on hospice care. (It will also save several times this amount of money by providing appropriate care for the dying rather than futile procedures in a hospital setting.)

Hospice is extremely valuable in our culture which has lost the habit and skills of taking care of the dying at home. They provide a consulting nurse who keeps in touch with both the patient and his or her doctor, providing adjustment of medication to ease suffering and equipment such as hospital beds or shower chairs that may become necessary. They provide 24 hour phone advice and expertise regarding the dying process. They organize volunteers who will spell a caregiver to go out for a walk or shopping and aides who can help with bathing. Besides being valuable, hospice is also extremely expensive (mostly paid for by insurance including Medicare) and often feels like a one-size-fits-all solution. Hospice is difficult for introverts and people who treasure their privacy. "Going on hospice" can be demoralizing. Hospice is mostly not available to people who are still undergoing life-prolonging treatments such as chemotherapy. The use of pain and anxiety medication often seems heavy handed. I have ranted about some of these issues in the past. All this aside, I am truly grateful for the existence of hospice services and devoted hospice workers who make dying at home and in peace easier.

But I think we can do more and maybe better. My friend who died, and his family, needed his wise friends and his multidisciplinary team organized by his specialist, his flexible and understanding primary care physician and, in the end, me to smooth the difficulties of his passing. It turned out that he needed a bare minimum of medication and remained intelligent and interactive up until nearly his final breath. He didn't need hospice, but he did need help. I think there is support that a community can provide that is beyond what a hospice organization does.

What we need is a network of people in our community who are good for different things, to share with each other and with people somewhere on the dying spectrum what they know. Emergency medical technicians know what needs to be done when somebody dies at home of a terminal disease and so do I, but families of dying people should know too. It would be reassuring. Lawyers know about what is needed to have a valid will. Priests, nuns and other clergy people are skilled in helping people find meaning in the process of dying. There are people in my community who always seem to be there when someone is very sick and they are comfortable with some of the worldly aspects of the end of life. There are people who have special relationships with animals who could give comfort by visiting with a cuddly creature. There are musicians of all description and artists who can brighten a dreary space. People who have recently gone through the death of a loved one might be glad to sit down for a cup of coffee or come along for a doctor's appointment to take notes or ask the right questions. They may know how to make the funeral process less expensive. There are social workers who would be founts of good advice. Some people know about helping write a life history. Some people can do guided imagery or hypnosis for symptoms control. There are needs and solutions I haven't thought of, and somebody in my community knows about them.

When I was pregnant with my second child, we hired a doula. She was a woman who had lots of experience with birth and who helped me with questions I didn't want to ask an obstetrician. She encouraged me, shared stories and sat with me the entire time I was in labor, which was a long time. Because of her confidence I didn't feel frightened and I didn't need labor anesthesia. There are also doulas for the end of life. There are none in my community, but I think there are people with the basic wisdom and experience to be a companion for a patient and family during the dying process. Death can be frightening but it doesn't need to be.

This network of people would not displace traditional hospice, at least not in most cases. It would be a volunteer organization and, with the possible exception of doulas, there would be no requirement to be "on-call." This would create new connections within our community. There would be unexpected and probably positive consequences. Each person who volunteered would know that, although they are giving now, they will be receiving at some point because death is going to happen to all of us.

The hospice movement that gained steam in the 1980's was very important. It helped move death out of the hospital and the intensive care unit and back home, where we can be surrounded familiar things that bring us comfort. I think we are ready to take the next step. We may be ready to use our collective wisdom to find the meaning in life's end, beyond the mistaken concept that death is a failure of medical technology. Life is valuable in part because we know we will die. Like birth, we only get to do it once. Maybe we can be intentional about it and help each other out by sharing what we do well.

Thursday, May 26, 2016

Is there a pill to make you live longer? The HOPE-3 trial and the hype that will surely follow ...

Today in the New England Journal of Medicine (NEJM) an article has appeared reporting the results of the Heart Outcomes Prevention Evaluation-3 (HOPE-3)trial. Exciting simplifications are sure to follow in the news. If you would like to stop reading now, the answer to the question posed in the title is probably no.

The question:

For many years researchers have discussed the possibility of a creating a pill that might contain several kinds of medication that would reduce people's risk of dying of cardiovascular disease. It is an attractive thought. Since cardiovascular disease is the major cause of death globally, reducing that risk has the potential to vastly reduce death and disability. Originally we thought that a suitable "polypill" might contain something to lower the blood pressure, something to lower cholesterol and something to reduce the risk of blood clots. Many studies have looked at the mortality benefits of various blood pressure pills, cholesterol lowering strategies and anti-clotting drugs and we have found that some of them help some people to some extent and some cause some people problems. Drat. So complex.

The history:

The original HOPE trial looked at a blood pressure pill (ramipril) which was added to whatever other medication a group of people at high risk of cardiovascular disease were taking. It lowered the risk of heart attack, stroke and death significantly enough that the study was stopped early and drugs in the ramipril class (Ace inhibitors) were aggressively prescribed, especially for patients with diabetes, probably to good effect.

The HOPE-2 trial looked at using vitamins to reduce homocysteine levels, which appeared to be a significant risk factor for heart attack and stroke. The studied doses of vitamin B6, B12 and folate did not reduce any of the outcomes they looked at. HOPE-2 was dashed.

In 2007 HOPE-3 began, looking at a combination of blood pressure medication and cholesterol medication, specifically to reduce death from heart attack or stroke, new heart failure, cardiac arrest or non-fatal heart attack or angina. The study was performed in academic medical centers all over the world, including the US, Europe, China and India, South Africa and Southeast Asia. Over 14,000 patients were enrolled, limited to men 55 and over and women 65 and over with intermediate cardiovascular risk (calculated at about 1% per year). Women 60-65 years of age were eligible if they had one of several specific risk factors, including glucose intolerance, smoking and high waist to hip ratios. These were people who had never had heart problems or strokes.

Drug company involvement:

Astra Zeneca helped fund this study along with the Canadian Institutes of Health Research. The cholesterol and blood pressure medication used in the study was on patent and sold by Astra Zeneca. The cholesterol pill was rosuvastatin (Crestor) and the blood pressure medication was candesartan/hydrochlorothiazide (Atacand/HCT). There were many drugs to choose from in the categories of effective blood pressure reducers and statin cholesterol medication, some of which would have been cheap and generic. The drugs they did choose are now generic but not yet cheap. I suspect Astra Zeneca hoped the study would have ended in time for them to reap financial benefits as their particular drug proved miraculously effective, or that the combination of the drugs could be made into a new formulation that would extend their market share.

So what happened? Getting to the point.

First there was a run-in phase. The 14,000+ patients were given the study drugs and about 2000 of them dropped out because they didn't tolerate them or didn't want to participate anymore. 12,000 patients were left. Of these about 3000 took placebo pills, 3000 took the blood pressure pills only, 3000 took the cholesterol pill only and 3000 took both blood pressure and cholesterol medication. After about 5.5 years, the patients taking blood pressure medication did not have a significantly lower risk of death, heart attack or stroke or the other cardiovascular outcomes. The patients taking cholesterol medication did have a reduced risk of death and cardiovascular outcomes. Taking both blood pressure medication and cholesterol medication was no better than just taking the cholesterol medication.

How big was the effect and how much does this cost?

The article quotes a hazard ratio of 0.71 for patients taking the combination medication, meaning that the medicated patient has 7 tenths the risk of a bad outcome of the unmedicated patient. The raw numbers are way more interesting. After about five and a half years of taking the combination of drugs or placebo, 163 patients in the active drug group had died and 178 of the placebo group had died, a difference of 15. At the present cost of these drugs, about $280 per month, it would cost about $3.7 million per life saved, which is pretty steep. Just taking the cholesterol medication, which is really the only one that had a positive effect, would cost about $2.6 million per life saved. If there were drugs on a $4 a month plan that did the same thing  we might get down to a very reasonable cost of $53,000, assuming no other associated costs like doctor visits or lab testing (which is not a fair assumption.) Death is not the only thing we care about, of course, but other differences, such as numbers of hospitalizations, were not much more impressive when I reviewed the supplemental data.

How about side effects?

To begin with, 2,000 of 14,000 patients did not like or tolerate the study drugs, so some of them probably had intolerable side effects. During the study, however, there weren't many important side effects except a bit more dizziness in the patients on blood pressure medication, which apparently didn't do them much good anyway. There was some muscle pain, but patients on placebo also had that. The dose of the cholesterol pill was very low, which might have explained the pretty awesome side effect profile. Also the patients most bothered by side effects probably dropped out in the run-in period. By the end of the study only about 70% of patients were still taking the prescribed drugs, so there may have been intolerance that was not reported. There was no excess of development of diabetes, perhaps because of the very low statin dose. Good studies have shown more development of diabetes in statin users, but doses are often significantly higher.

Other interesting findings from the supplemental data:

I was very pleased that the NEJM published a well written summary of data that didn't get discussed in the article. There were some really weird things that showed up.

  1. South Asians and to some extent Chinese subjects did not have near as much benefit from the study drugs as did subjects of European descent. 
  2. Stroke risk was actually higher for patients with borderline high blood pressure when they were treated with the blood pressure lowering drugs, though reduced for patients with higher and lower blood pressures. 
  3. Patients with the highest cholesterol levels (LDL greater than 141, mean of 166) did not benefit from treatment with cholesterol lowering drugs. That's really strange and counterintuitive.

Bottom line?

We have not discovered a pill yet that will make everyone live longer. Taking a statin drug which lowers cholesterol (who knows if that's the important effect) may lower your risk of cardiovascular disease or death, but you need to take it a long time to make a small difference and we aren't sure which one is most effective. Most people who take statin drugs (Lipitor, Crestor/rosuvastatin etc.) for primary prevention (meaning they haven't had heart attacks or strokes) will not benefit from them. Low doses of Crestor/rosuvastatin usually have a low risk of side effects. Treating normal or slightly high blood pressure with low dose candesartan/HCTZ doesn't reduce the risk of heart attacks, strokes or cardiovascular death. Navigating the pros and cons of all of these pills and potions is neither obvious nor simple and is best done with a doctor who you know and trust.

Thursday, May 12, 2016

Medical error--the third leading cause of death, or not nearly so simple?

Splashed over news feeds this last week is a reference to an article published last week in the BMJ (formerly known as the British Medical Journal) that states that "medical error [is] the third leading cause of death in the United States."

What is this article actually about?

The new article refers to research done over the last 2 decades, and most recently an article by NASA toxicologist and patient safety advocate John T. James PhD in the Journal of Patient Safety in 2013. Dr. James evaluated 4 previous studies and estimated that 400,000 people, approximately, die yearly in the US of conditions that were either caused by or, more often, made worse by medical error.

That article, too, was met by outrage and was widely quoted and misinterpreted. I think hardly anybody actually read the article. Headlines read "Deaths by Medical Mistakes Claim the Lives of 400,000 People Each Year."

No new data, but a new way to think about it:

As far as I can tell from reading this most recent article, in BMJ, there is no new data. There is just the realization that if this many people are dying of medical error, it should be showing up somehow as a major cause of death, just like heart disease or cancer. The reason that it is not is because the questions that are asked on death certificates do not include anything about whether medical error had occurred. The article, quite correctly, states that this should be documented. Documenting this is the first step toward making major changes that will keep patients safer.

So what did the original article actually say?

When Dr. James' article came out in 2013, I read it and wrote a blog commenting on the study, its methods and what medical error looks like from my experience. Dr. James kindly responded in a comment,
"Thank you for putting my JPS study in an appropriate perspective. Some folks like to sensationalize the results as if these patients die only because of a medical error, and that is not what I wrote or intended."
The blog from 2013 was actually pretty good and completely relevant to the recent news release. You may want to read it. It does put the data into perspective.

Patient safety--very very important!

I am glad that this recent article has grabbed international attention for patient safety. What we read in USA Today and the rest of the popular press is not an accurate depiction of the problem, but the problem remains very real. Medical error is contributing to the deaths of hundreds of thousands of patients yearly. We, as physicians and healthcare providers, are trusted with the lives of vulnerable people, and it is up to us to build processes that allow our good intentions to be translated into good care.

Sunday, May 1, 2016

Practical and commonsense research from Ontario's Physician's Services Incorporated Foundation: Let them drink apple juice!

Today in JAMA online (the Journal of the American Medical Association) a delightfully practical article was published regarding how to help little children recover from gastroenteritis (stomach flu.) The authors, Doctors Stephen Freedman, Andrew Willan, Kathy Boutis and Suzanne Schuh, compared the health of over 600 children aged 6 months to 5 years, when given a medical rehydration solution to drink versus diluted apple juice along with the fluids that the child preferred. These children were not chronically ill or severely dehydrated, but were sick enough to have been brought by their parents to the emergency department and were at risk for needing hospitalization or intravenous fluids.

In previous studies oral rehydration with electrolyte solutions such as Pedialyte, which contain over twice as much sodium and 6 times as much potassium as sports drinks, along with much less sugar, had performed well in preventing hospitalization or return to the emergency department. Theoretically, children would need electrolytes to replace the ones lost in diarrhea or from vomiting, and extra sugar would just draw more fluid into the intestines, worsening the diarrhea. In the children studied in this recent research, however, giving a teaspoon of dilute apple juice every 2-5 minutes and treating vomiting with a very effective anti-nausea medication, ondansetron, by mouth, worked at least as well, actually significantly better than the same routine using bottled electrolyte solutions. This was particularly true in the children who were over 2 years old and so had definite taste preferences. Children given dilute apple juice and then liquids that they preferred were less likely to be admitted to the hospital or need intravenous hydration than children who were provided oral electrolyte solutions.

There has been a magic associated with giving children Pedialyte or similar solutions for their mild intestinal ills, despite the fact that it is more expensive (1 liter costs about $9, though may be as cheap as $5 when bought in bulk) and doesn't taste very good. Children mostly don't mind it, but some really do, which can be a big factor when they are feeling queasy. This study presents evidence to allow parents to give their children pretty much any liquid that sounds good, making an extra trip to the pharmacy with a sick child unnecessary.

Now oral electrolyte solutions and apple juice have both been available from many manufacturers for many years. What drug company, then, would be interested in funding this lovely research? None, of course. Could it have been funded by a governmental agency? Yes, I guess so, though much of that grant money is very hard to get. This study, though, was funded by a private foundation with a very interesting story.

In 1947 physicians in Ontario, Canada, joined together to create a pre-paid health plan. The physicians pro-rated their fees to stay within budget, and eventually 8000 doctors participated. In 1969, the Physician's Services Incorporated health plan ceased to exist and was replaced by a state run entity, now the Ontario Health Insurance Plan. There was still money in their account when they stopped providing services (they must have been doing something right) and the physicians decided to use it to create a foundation to improve the health of the citizens of Ontario. The original investment of those physicians was $16.7 million, and in the years since inception over $167 million has been paid out in grants. They now have around $90 million from which they fund over $3 million in grants yearly.

If you are interested, read the 2015 annual report for the foundation. The projects they fund are wonderful. There are little grants, one for $5500 to a physician who wanted to study lower doses of a testosterone product for female to male transsexuals. There are larger grants as well. There is a project to grow mats of human cartilage from small numbers of cells to heal the damage of osteoarthritis, reducing the need for joint replacements. There is a fellowship for a researcher who will take scientific research and bring it to the bedside, this year a nutritional expert who works on creating healthy diets. The money granted to this person is to free them up to do work that will not provide them any likely financial benefit. There is a study to look at the side effects and impacts of those side effects on patients who take the (often not very effective) drugs for Alzheimer's disease. There is a study looking at whether giving children who receive antibiotics in the hospital a probiotic milk product (kefir, I'm thinking) reduces their risk of getting antibiotic associated diarrhea. The studies are all like that: practical, meaningful, unlikely to increase healthcare costs and likely to improve health. They are studies that are not often done in the US, where drug companies are our major funding source, expecting to make more money selling drugs than they spend on research.

The PHI foundation is much smaller than the Rockefeller, Howard Hughes or Bill and Melinda Gates foundations which privately fund research in the US. Even so, they helped Dr. Freedman et al publish a paper that will allow the next generation of babies and toddlers to drink dilute apple juice rather than electrolyte solutions and be more likely to stay out of hospitals as they recover from their tummy troubles. Their other grants are just as good. They are a model of medical research funding I have not seen before. They are private individuals, doctors even, who have worked together to do something great. They are not super rich philanthropists, drug companies or federal government agencies.  This organization is making a powerful and positive impact by funding and encouraging researchers who are wise and curious.

Friday, April 22, 2016

How bedside ultrasound was awesome last week

I sometimes do locum tenens assignments as a hospitalist in rural hospitals. It is a good way to find out how other systems work, or don't work, and meet new people and interact with new communities. It's great to be home and also good to go away and come back later.  Besides the usual trappings of doctoring, including stethoscope, otoscope and white coat, I wouldn't be caught dead without my pocket ultrasound.

I just got back from a week of 12 hour shifts in a 48 bed hospital and once again was very happy to have the ultrasound. They do have ultrasonography in the radiology department at this hospital, but echocardiography (ultrasound of the heart) is only available on weekdays from about 8 to 5, and it needs to be scheduled in advance. Also the ultrasonographers don't necessarily look at the things I find interesting, and can't combine imaging with physical exam findings and what the patient tells me in real time. Patients also really enjoy seeing what's going on inside when we both look at the pictures together. Ultrasound has been part of my usual practice for 4 years now, and you might think it would get old or boring, but it hasn't.

These are a few of the cases in which it made a huge difference to a patient that I had access to ultrasound at the bedside as part of the physical exam:

1. A man came in with a history of heart valve surgery and swelling of the legs. It was not clear how well he took his medication at home, but he was known to have congestive heart failure. He had had a large pericardial effusion with tamponade (fluid surrounding the heart causing it to fail) a few months before I saw him. The bedside ultrasound ruled out tamponade and showed that his heart failure was in pretty good control. He improved impressively with just staying on his regular medication and keeping his feet up. Without the reassurance of the ultrasound I might have given him extra diuretic medication and perhaps caused kidney failure. I also might have had to send him to another hospital for a full scale echocardiogram to rule out tamponade, which would have required an emergency intervention.

2. A person with a long history of alcohol abuse came in feeling generally terrible. After treatment for alcohol withdrawal, he developed very low blood pressure and high heart rate with a low grade fever. Ultrasound of the left lung showed a definite pneumonia, though the chest x-ray visualized that area poorly, missing the pneumonia completely. Having this diagnosis helped considerably in diagnosing sepsis and choosing the right antibiotic as well as ruling out a heart problem as the cause of the vital sign abnormalities.

3. A very old man came in from home with a recent history of bleeding from his urinary catheter due to pulling on it. The family was worried about blood clots obstructing the catheter. A very quick ultrasound reassured them that all was working as it should have been. The patient was saved having the catheter unnecessarily removed and replaced.

4. After a motorcycle wreck which caused rib fractures and a pneumothorax (popped lung) a patient had persistently low blood oxygen levels. She was also a smoker so the differential diagnosis included worsening pneumothorax or simply not breathing deeply due to pain. The little ultrasound detected no pneumothorax so treatment was aimed at improving breathing rather than considering placement of a chest tube. There are many other imaging procedures that could have made this determination, but none of them were instantly at hand when I needed the answer.

Bedside ultrasound is gaining popularity as a tool for internal medicine physicians and hospitalists, but is nowhere near being universally or even commonly a part of our practice. It does take training, practice and the little machine in the pocket or easily available on a cart in the clinic or hospital floor. Truly, these are obstacles, but totally worth tackling.