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Friday, February 24, 2012

Wound care products--a rapidly expanding market, and way too expensive

About 15 years ago a non-healing wound on a  person with diabetes or vascular disease was treated by surgeons and primary care physicians, sometimes by podiatrists, and would take months or years to heal and often lead to amputation. Wounds like this were depressing for both patients and physicians because they combined pain and hopelessness and resulted in death, disability and use of lots of resources.

Starting about 10 years ago, I started to see, from my primary care practice, fancier wound dressings and doctors and nurses who specialized in taking care of wounds and ulcers. This was a great relief to those of us on the front line, struggling and failing to heal these things. The success rate for healing seemed to improve, but ever so slowly.

The problems with healing a wound involve the fact that wounds happen for a reason, unhealthy tissue or lack of sensation leading to injury or fluid buildup from internal problems or pressure due to immobility. Many of these issues will continue to encourage wounds to stay open while care providers are doing what they can to make the wound close. Also, open skin leads to bacterial growth and infection, and once bacteria establish in a wound, it is difficult for it to close. The treatments that are intended to reduce bacteria, like antibiotic and antiseptic chemicals often are toxic to growing skin cells as well as infecting bacteria. The old fashioned "wet to dry" dressing had just this problem. Gauze was placed on a wound wet, allowed to dry, then pulled off taking infected goo and healthy skin with it. It was usually counter productive and incredibly painful.

Wounds can be dry, with a stable scab that doesn't want to heal, or wet, sometimes oozing spoonfuls of lymph and such in a day. They can be small and deep or large and superficial. They can involve structures underneath, such as bone and muscle. All of these different kinds required different approaches.

Wound care products attempt to address all of these issues with creativity and technology and often include pieces of folk wisdom and stuff that worked in the past. We have greasy zinc oxide paste with herbal additions to prevent breakdown of chronically wet skin on bottoms, much like the old fashioned desitin which was probably used on the bottoms of my generation of babies. We have absorbent products made of various types of foams and fibers, some containing antibiotics, but more often silver, since it is antibacterial without being irritating or inhibiting skin growth. We have lab grown skin graft material that can be used to cover a clean wound that needs more active healing. There are dressings that are made of sticky wax that can stay on for days to protect an ulcer in a place that gets lots of friction. In the last few years particularly gnarly wounds have begun to be treated with wound vacuums (wound vacs) that place gauze or foam on the wound and then create a small amount of suction meant to pull tiny blood vessels and healing fluids to the surface to improve healing. These also conveniently remove pus and liquid from wounds that exude so much that they can't be kept clean. Hyperbaric chambers expose people to high levels of oxygen which can heal stubborn wounds that don't respond to the usual treatments. There are new topical gels and ointments that use such things as honey and silver as well as iodine and anitibiotics, and there are products that use the body's growth factors to improve cell growth.

Lots of hope, but at a really high cost! The foam or fiber dressings cost between $150 and $250 for a box of 10 four inch squares. The gels cost upward of $80 for 1.5 ounces. A day on a wound vac in a nursing home costs nearly $100, paid by medicare until the benefit is exhausted. A day in a hyperbaric chamber can cost from $200-$1000 depending on whether it is located in a hospital or a private clinic (more expensive at hospitals.) Wounds are healing  up faster than they used to do and are more comfortable and less smelly for patients. The basics required to heal a wound remain the same: good nutrition, not smoking, avoiding infection or reinjury and improving blood flow. Fancy dressings are helpful, but their relative contribution compared to the basics is small.

Ideally what we need is a magic potion that heals wounds cheaply and relieves pain. It would be nice if it also was readily available and didn't require refrigeration. If such a thing existed, though, we would already be using it. Or would we?

The wound care industry is growing faster than health services in general, and products that can be made and patented and sold for lots of money, especially to patients with good enough insurance to pay for them, drive this development. Surely there are great new products out there, and I congratulate the innovators who come up with these new ideas. But this mechanism and these incentives do not favor the development of cheaper or simpler approaches. There are public funding sources in medical research, but industry really drives the development of products.

Enter heparin. Heparin is one of the oldest drugs still used, first isolated from dog liver in 1916 at Johns Hopkins and used in humans to inhibit blood clotting beginning in 1936. It is a chemical released at the location of injury, and probably functions more to stop infection and increase healing than to stop blood clotting in its natural state. Nobody holds a patent on it anymore. It is known to increase the growth of blood vessels in animal models, and it is used extensively in the treatment of burns in many countries. I can find only a few studies on its use in treating wounds, though there is abundant information on its effectiveness from the places that routinely use it to treat burns. Evidence suggests that in the treatment of burns it dramatically reduces pain and speeds healing. It is used intravenously for very large burns, like those related to explosions, and is applied topically for smaller burns. But wounds are another question.

Michael Saliba MD studied burns in an animal model decades ago at UC San Diego and has since been involved in trying to get out the word of its effectiveness. He has lots of research to support its use, but most of it is done outside of the US and the very fact that it works so well makes blinded studies impractical. Some research is ongoing. Since it relieves pain so effectively, those treating patients with it know who is getting it and who is not. Healing is also much faster, which is hard not to notice. It is used most commonly in resource poor countries (Nepal, India, Mexico, Bulgaria, El Salvador to name a few) due to its very low cost, and withholding an effective treatment in life or death situations is difficult to condone. So frustrating. Something that really works, and because of its familiarity it essentially flies under our radar.

When I asked Dr. Saliba about non-burn uses for heparin, given its mechanism of action, he told me that it did work for many chronic ulcers. I was in the process of leaving my primary care practice at the time, but had the occasion to use it once before I left. The patient was a big smoker who had just had a heart attack and had then fallen down, jabbing a sharp piece of pipe into the front of her leg. After a few weeks of dressing it, it had still not begun to heal and she was beginning to have a really nasty rash in response to the sticky dressings that was beginning to turn the whole leg into an oozing piece of meat. It was imperative that I use some sort of treatment that didn't require a fancy dressing. I went across the street to the hospital and bought some vials of heparin and applied them to the wound. I then wrapped it with gauze. The next day she was better, and so on until she was completely healed in about 2 weeks. Pretty cool, I thought.

Since that time I have been working as a hospital doctor and haven't had the opportunity to treat wounds myself. Most hospitals have specific wound care services and I felt uncomfortable pushing my new and clearly  unconventional ideas about topical heparin. But 3 days ago I got back home after a week away working and found that my son, who had just started a martial arts conditioning class, had torn the skin off of his knuckles which were painful and oozing. He figured he wouldn't be able to go back the next day and punch the heavy bag. I found one of my little leftover vials of heparin, dabbed it on, let it soak awhile, put on bandaids and he was almost totally healed the next day. Wow. A diabetic friend with an ulcer on his ankle  that was really cramping his style (coincidentally also this week) asked for advice and I suggested the heparin and a bandaid technique and (I'm told) after applying it at night he could barely find the spot in the morning. Wow again.

I am stymied. Having cognitive dissonance. Confused. What is with this whole heparin thing and why don't we use it? I went to wikipedia and the author of the heparin article mentioned many possible uses for heparin, but not wound healing or burns. I found one article that really pertained to the question on a google search  (http://www.ncbi.nlm.nih.gov/pubmed/8900676) which suggests in its abstract that heparin really does work for wound healing, but it was published in 1996 in the Journal of Ostomy and Continence Nursing. Something with that level of impact on practice should have been on the front page of the New England Journal, and followed up instantly by other journals with confirming or explanatory articles.

Since the main wound care nurse at my hospital is a good friend, I think it's likely that we will get a chance to try heparin more often and see if it lives up to what I have seen so far. The treatment of large burns is not within my practice, but maybe I'll have a chance in the next year or two to visit places where it is used. Certainly the coming focus on bundling payment for conditions (which will include burns) will introduce a powerful incentive to look at therapies that are effective and inexpensive. Until that time, I hope if I get a big burn it will happen in Mexico!

Monday, February 13, 2012

Seeing into the human heart--Valentine's Day and the GE V-scan pocket ultrasound

Valentine's day is a silly holiday, sort of. Really unpalatable sugar hearts in colors not seen in nature with provocative non-sequiturs printed on them and children making 30 nearly identical tiny greeting cards for their class members and little stuffed puppy dogs with oversized plastic eyes holding satin heart pillows for sale in grocery stores and and and...yet... It is actually pretty wonderful that America celebrates a holiday in the middle of February, a very dreary month, that is dedicated to love and the human heart. Even if that holiday is  hyped to a ridiculous level of excess by retail enterprises, it is still overall a good thing.

I am presently a fan of the human heart. After going to a short ultrasound course put on by the Department of Emergency Medicine at Harvard Medical School in November, I have been intrigued by the possibility of making ultrasound imaging a routine part of a physical exam, since it is harmless and uses no resources. When I got back from Harvard, I borrowed the small portable ultrasound machine in our hospital and ultrasounded everyone who would hold still when my working day was not too busy. The machine was inconveniently located in radiology and took awhile to get upstairs, but I still used it pretty frequently. I started out self conscious and inept and gradually began to be able to use the transducer in such a way that I could obtain images of the structures I was interested in, some or most of the time. In the first 3 weeks after the course I probably did 20 ultrasounds, with many disclaimers to the patients that I was just practicing and didn't really know what I was doing. They were nevertheless interested, and I found that the extra time I spent with them lead to more in depth sharing of stories and the images that I could get helped with diagnosis and treatment.

At the Harvard course there were lots of device sales people hawking their expensive machines, and one of them was a woman from General Electric who had a really little machine, small enough to go in a coat pocket, which gave pictures almost as good as the big machines. After dragging the portable but definitely not pocket size machine around our hospital for a couple of months, I decided that I needed to buy this pocket sized gizmo. I searched for deals online and found that there were many options, but that for what I wanted, small size and good picture, the GE machine was it. Siemens makes a nice slightly larger and slightly more expensive machine and a company out of Seattle makes a machine that uses an iPhone as its interface. This was intriguing, but I heard the pictures were just too small. I also found that farmers and veterinarians use ultrasounds and that theirs are much cheaper and would be perfect except that the transducer is shaped to go in an animal's rectum to image pregnancy and would not be what I would need for looking at people from the surface. The cost of the GE V-scan was nearly $9000, which only looked good in comparison to the larger models which are the size of a laptop and cost upwards of $50,000. I thought of how some rich hospital should maybe buy the pocket ultrasound for me, and realized that without having it and using it to know its utility, there would be no way to convince anyone to buy me one. I rationalized that I had not bought myself a new car since 1992 and didn't intend to anytime soon. I then shelled out the bucks. To buy this, I had to prove that I was a real physician and it was shipped to my work rather than home. I'm not sure who this was supposed to protect, but that's how it was.

Since buying my ultrasound I have begun to use it routinely, much as I would my stethoscope, but with greater confidence and it is incredibly helpful to determine whether a person has congestive heart failure, whether they are short of breath from a weak heart or from infection, whether they need more or less salt and water. I can also identify enlarged livers or spleens and can see if a bladder is full. With more training, which I will eagerly get in the next few months, it will become even more useful. There are so many decisions that I can make more confidently knowing what the insides of an individual look like, especially the heart.

The heart. The human heart is the most amazing thing. It is not hard to see why it has taken such an important place in art and literature. During medical school I looked at still pictures of the heart and dissected dead hearts and photos of x-rays of hearts and even the occasional ultrasound image. We learned how the blood flowed--from the body to the central veins, the inferior and superior vena cava, to the right atrium and then right ventricle, out to the lungs, then back, oxygenated, to the left atrium and ventricle, then out via the aorta to serve the body. But there is just nothing like looking at the heart in real time. Ultrasound allows you to tour the human heart, look at it from all sorts of angles, and though the picture is 2 dimensional, the myriad views I have allow me to perceive it in 3 dimensions.

The left side of the heart is the larger of the two sides and gets most of the attention. I am presently intrigued with the right side, though. The right side is not as strong a muscle as the left side, because the resistance in the blood vessels of the body is higher that the resistance in the lungs (except in severe pulmonary hypertension, which is a very bad disease.) But the right heart looks different from the left in a way that is utterly awe inspiring. The right heart dances. At least it does when it's healthy. The ventricle, which is more muscular than the atrium, pumps blood out, and as it does its contraction acts to pull blood into the right atrium from the great veins. They never told me that in medical school, but when I look at it, the process is absolutely clear. And when the atrium contracts to send blood into the ventricle, this thin walled structure appears to wink, as fast as an eye. It is totally cool to watch.

From the fact that I am able to get useful information from my little machine after very little training (though lots of practice) it is clear to me that this will become much more common and it will reduce the need for various blood tests which represent the state of health or disease of our innards much less accurately. Already emergency department residents are required to have a certain level of ultrasound competence to complete their programs. This will become standard in other specialties as the technology becomes cheaper and easier to use. I hope this new generation of physicians will search for the ways in which routine use of imaging can streamline diagnosis and spur useful conversations between doctors and patients. I hope they will also continue to be awed by the ability to see the inner workings of peoples' bodies.

Tuesday, February 7, 2012

Finding a mentor, and the joy of working with physicians who are not sheep

Many physicians are thoughtful, intelligent, compassionate and creative, but the process of training for this job doesn't necessarily foster those qualities. And let me be clear, I have nothing against sheep, other than to have noticed that people who keep them don't seem to be particularly impressed with their problem solving abilities. I think that when we as physicians get particularly tired and overworked, we stop thinking for ourselves.

When I went to medical school at Johns Hopkins, there was a subset of clinical teachers who I thought of as the "grand old men and women of medicine." They were the people who understood their subject area with keen insight and who loved to teach. I felt privileged to be near them as they visited patients and explained their thought processes. Their ideas were fresh and they were passionate about them and they were definitely not sheep.

My recent locum tenens hospitalist job was really busy and there was a tendency to test and treat patients in ways that did not seem ideally suited to their individual needs. It was expeditious to do cardiac enzymes and then a nuclear stress test on everyone with chest pain who had any measurable risk of coronary artery disease, but I cringe to think of the cost and the radiation exposure associated with that approach. The American College of Physicians has made a recommendation that people with normal electrocardiograms who have chest pain can be risk stratified with a regular EKG stress test, without nuclear imaging without significant harm. The cost of a nuclear stress test is around $7000 whereas a regular stress test costs less than $400. Cardiologists and the hospital make more money on the nuclear tests, but the associated radiation will result in excess cancer risk. Invasive and higher risk procedures are compensated better than thinking and talking and this leads to increased use. The level of acceptance of routine use of procedures for testing and treatment is determined by the healthcare culture that is present in a hospital or community. I think the patients at the hospital where I worked got good care, but I wonder if their outcomes were any better than they would have been at an institution with more frugal use of resources.

The hospitalists in my new institution are responsible for taking care of most of the patients who are not critically ill in the hospital, but when these patients need ventilators or very frequent monitoring or vasoactive drips they are transferred to the intensive care unit where they are cared for by a physician who is assigned to just those patients, a critical care doctor. We hospitalists would occasionally go to the ICU to meet a new patient who had been adequately resuscitated to graduate to a regular medical floor, and in one of these visits I met the night shift intensivist who is also definitely not a sheep. He is an astute diagnostician and had great ideas about physiology that helped make sense of the very sickest patients. After a conversation that involved my present passion for bedside ultrasound to help manage medical patients, he offered to "show me stuff."

Physicians who are not sheep frequently do things in ways that make sheep uncomfortable. This ICU doc showed me his technique of putting in a central line in the subclavian vein using ultrasound guidance and a skin tunnel to prevent infection. Some physicians now use ultrasound to put in central lines, but rarely in the subclavian vein and I have never seen a tunneled central line placed by an intensivist. Now it is true that my exposure to this sort of thing has been limited for the last 20 years, but I'm pretty sure this is not only the right way to do it but also very uncommon. Skin tunnels prevent the bacteria that is always present on the outside of a human from getting into the blood stream, which is supposed to be pretty much devoid of bacteria. There are special central lines that are placed by surgeons that are tunneled and have special cuffs for use in lines that are expected to be left in place for a long time. The hardware and the placement process are really expensive. The procedure I saw involved the standard central line equipment and a bedside ultrasound machine and was beautiful. His procedure was relaxed and graceful and the patient was treated with respect. I was inspired.

Atul Gawande, the physician/writer for the New Yorker, wrote about being coached in doing surgery, and about how useful it was and how uncommon. Mentoring in medicine stops for most of us when we reach our final year of residency and from that time on, with the exception of short continuing medical education courses, we pretty much make things up as we go along. This year I have started to spend more time with doctors who know things that I don't know. The only way I could really do this is to pull away from the very full time nature of my primary care job and deliberately spend time listening to and watching people (doctors and technicians) who I respect. In the last few months I have seen many professionally done echocardiograms and ultrasounds, have watched my radiological colleagues do procedures and have seen a total hip replacement. Everything I watch opens up my horizons a little bit. I'm looking forward to more of this.

Wednesday, February 1, 2012

Adventures in Hospital Medicine

I just started my first out of town doctoring job. I flew out for an orientation on Thursday and then drove back here for the week of work on Sunday. After Thursday's hospital visit my reaction was "what was I thinking when I said I would do this?" People go through a lot of trouble to end up in jobs where they are comfortable, well known and respected. This job, at least from the vantage point of last Thursday, was a very different thing. I would be responsible for somewhere between 12 and 20 patients who I knew nothing about in a hospital which has over 200 patient beds, 5 floors, 3 adjoining buildings, using two entirely new computer systems.

So what happened? I did sleep well the night before I started, which was great. They gave me 12 patients to start, and my beeper was mercifully quiet for the first 4 hours of my 12 hour shift. The patients were just people, like they are anywhere, which was reassuring, and they were grateful to have someone talk to them and listen to them and try to solve their problems. The computer systems were user friendly compared to lots of computer systems I've seen in medicine. The staff was harried but supportive. I  brought my lunch. I got two admissions and discharged 3 patients and as far as I know I didn't make any heinous errors. The second day was a little harder but I was more comfortable, and today was ridiculous, with people needing to be seen at the same time in multiple areas of the hospital, some of them with logistical issues that were time sensitive, like discharges and procedures, and some of them with actual acute and life threatening illnesses needing intervention. Again, no obvious heinous errors, and everyone was quite understanding.

I'm starting to develop a routine that coordinates gathering all of the nearly infinite pieces of data that go into modern medical care (vital signs, lab tests, imaging results, nurse's observations, consultants and primary care docs' input, physical exams and patients' stories) and then seeing patients, admitting and discharging them and writing notes. Today was a little too free floating, I think, or maybe my patients were just really sick, but I ended up not getting out of there until an hour and a half after my shift was over. I shall make some subtle adjustments tomorrow and see how it goes.

I think this hospital, which is larger than the one I normally work in, has adjusted to the fact that the hospital docs, like me, are stretched thin, and even the patients are a bit more patient than I would be in their position. There are routine errors related to discontinuity of care, such as misdiagnoses and redundant tests and procedures. In general these have not seemed to have dire consequences, but they definitely could. There are systems in place to reduce this risk, but the frequent hand-offs of patients are difficult to do without information loss, Impossible, even. In my home hospital we do 24 hour shifts, going home at night, but always available within 20 minutes or less to come in if necessary. We usually do several days in a row, and know the patients pretty well by the time they are discharged. Our signouts are face to face, whereas the routine with my present job involves only a one or two paragraph computerized communication. With 12 hour shifts and a night and swing person covering all of the patients, face to face hand offs are not logistically possible.

I'm staying in a rather seedy hotel, but in a large room with a kitchen. I have very little time here, so the seediness doesn't much matter. I bought food at a grocery store and have been having comfort food meals like fresh raspberies, croissants with brie and nutella, ramen and hard boiled eggs and greasy chicken thighs. It's hard to improve on that! The locums company I work for will pay for my meals and lodgings so I could be eating out every night, but I shudder to think what a restaurant would charge for the fresh raspberries.