An article from Sweden was recently published showing that in a very large group of women, over 60,000 of them, followed for 19 years as part of an also very interesting study of the effectiveness of mammograms, women who get more calcium, in their diet or as supplements, had a higher risk of dying of anything, but especially of heart attacks. It is unclear why this would be true, but there are various theories.
Further, the study showed that this risk was more pronounced if the calcium was taken as supplements, but still present in women who got their calcium from the food they ate. The highest level of risk was in women who got more than 1400 mg of calcium a day, and an intake of 700-1000 mg a day did not particularly increase risk. The women with the lowest average calcium intake were not at any increased risk of death, which was a surprise to the researchers. Information about calcium intake was taken from the subjects' reports of diet and supplement use, which was further validated by phone interviews of recent food intake. Since most women think that consuming calcium is healthy, I would guess that there was a tendency to overestimate calcium intake, suggesting that real risk may be present with lower calcium intakes than the study states.
This is big news. Or is it? No, it actually isn't. In 2010 the British Medical Journal published a meta-analysis of studies of calcium supplementation in healthy people and concluded that there was increased cardiovascular death in those given supplements. There had previously been studies showing that calcium supplements in dialysis patients accelerated calcium deposition in blood vessels and increased cardiovascular death.
It has been part of our general medical wisdom for my many years of practice to recommend calcium, as food or pills, to our women patients. I remember several years ago when we began to be aware of the real impact of osteoporotic hip and spinal fractures in our aging population that physicians were encouraged to recommend to our post-menopausal patients that they take 1200-1600 mg a day of calcium. That was very hard to do. A cup of milk contains about 300 mg of elemental calcium, yogurt slightly more, cheese not much at all. Calcium fortified orange juice was about as much as milk. Dark green leafy vegetables contain calcium, but not a whole lot. A cup of collard greens, cooked, contains about 350 mg, but people rarely eat that much cooked greens. I would work through how to get all that calcium in the diet and usually suggest my patient take a chewable calcium pill for every meal they didn't eat something that was high in calcium. Luckily for my patients, I doubt many of them really did this.
Calcium supplementation seemed the right thing to recommend after estrogen, which is well known to reduce fracture risk, was discredited by the Women's Health Initiative due to what appeared to be an excess of heart attacks and strokes in treated patients. There were other medications for osteoporosis, but they had side effects and were really only approved for established osteoporosis, which most patients don't want to wait to get.
But why did we ever recommend calcium supplements at all? Did we have any good evidence that they worked? Sort of, but in retrospect, not really.
It does make sense, when you think about it, that calcium would strengthen bones. Bones are, after all, made mostly of calcium. Over the last 3 decades at least we have studied the effects of calcium supplementation on both bone density and on risk of fracture. We care most about risk of fracture, because bone density is just a test, and is not necessarily indicative of whether a person will break a bone. The most important kinds of fractures as we age are those of the hips and vertebrae. These are the ones that cause disability and death and are associated with the thinning of bones that comes to many of us with age, that is to say osteoporosis. Although some studies early on appeared to show that taking calcium, with or without vitamin D, reduced these important fractures, later analysis of all of the well done studies showed no benefit. There was even a suggestion that higher calcium intake might have been associated with more hip fractures. Many of these studies were done in the most scrupulous way possible, using double blind prospective methodology or correcting for factors that might make patients with higher calcium intake be those who were at higher risk of fracture in the first place.
What about vitamin D? Does this make a difference? In the Swedish mammography cohort, vitamin D supplementation did not reduce the risk of heart attack or death that was associated with increased calcium intake. In a recent large study out of Finland from 2010, combining calcium and vitamin D had a slight but not statistically significant effect on fracture risk in a group of 65-71 year old women living in northern Finland. Vitamin D itself is the subject of lots of research and although it may be good to supplement it, especially in people with risks for low levels, it is not clear that it reduces the risk of fracture in the majority of post menopausal women.
So what is the bottom line here? It does appear that taking calcium supplements and deliberately pushing high calcium foods increases risk for death and doesn't save a person from disabling fractures. Doctors have so many things that they need to advise people about in a preventive office visit, getting exercise, quitting smoking, controlling their blood pressure, getting vaccinated against dread diseases. Now we just don't have to also tell our patients to drink milk and take large and unpalatable calcium pills. We should probably tell them if they are already doing that, to stop the pills and concentrate more on a healthy balanced diet, with plenty of fruit and vegetables and fish and olive oil. We can rejoice in having one less thing to fuss about!
Saturday, March 16, 2013
Friday, March 15, 2013
Female feticide --ethical issues of ultrasound in India and China
The use of ultrasound has had a large impact on health care in resource poor countries. This article details some of the research that has been done overseas to look at the impact on bedside ultrasound by caregivers to deliver more appropriate care for injured and ill patients in Africa, Asia and Mexico. Using an ultrasound to determine how dehydrated a child is, whether an injured person requires surgery, whether a person who has collapsed has a blood clot or a punctured lung or fluid around their heart and treat those things appropriately is incredibly powerful and, after paying for the machine, costs nothing but the time to train practitioners.
It is possible to find some of the most interesting and cutting edge uses for ultrasound in the literature from developing countries because they have the equipment and, lacking CT scanners and x-ray machines, they have ample motivation to use it to its greatest advantage.
In India and China, however, which both need low cost alternatives for diagnosis and treatment, ultrasound use is regulated because of the common practice of using it to determine sex of the fetus and then to selectively abort female fetuses. In China, the one-child law combined with a preference for male children and led to female feticide and then laws to prohibit use of technology to determine the sex of the fetus before birth. Apparently the law is difficult to enforce and so sex specific feticide continues there. In India conservative estimates of the number of female fetuses aborted was about 250,000 per year. There are campaigns by the government to encourage valuing female children, but the economic and social reasons that the problem exists in the first place are at the very basis of the issue.
When a woman in India is married it is still traditional to offer the family of the groom a hefty dowry. There are laws against dowries but that doesn't seem to have changed the practice much. Women also work at jobs which are less prestigious than men and earn lower wages. At marriage, a woman customarily moves to the home of her husband and is no longer available to take care of her own parents. So girl children are expensive.
It is much cheaper to get an obstetrical ultrasound in India than in the US, but still very expensive in comparison to overall cost of living. Getting an abortion is also relatively inexpensive, but costs money, which poor families actually don't have. It is far less expensive to have the baby and abandon it or kill it, and female infanticide is also pretty common in India. An article in the Atlantic Monthly looked at this problem and some strategies to deal with it, such as safe places where babies can be left, no questions asked, for adoption or care.
General Electric Healthcare, the company that makes the tiny pocket ultrasound that I use, and also makes a full range of amazing ultrasound equipment, was severely criticized and was even in legal troubles regarding the perception that they were complicit in sex determination of fetuses. This file describes their experience. Apparently they are actively involved in trying to enforce Indian law and have, according to some of my contacts, been less willing to donate equipment in India, which they had done before. The manufacturers are legally responsible for how their equipment is used, per a 2004 change in the laws about prenatal sex discrimination.
It seems to me that the attempt to regulate use of ultrasound in order to reduce the abortion of female fetuses is doomed to complete failure. It is just too easy to do an ultrasound and see a fetus's genitalia. An economically motivated family certainly can arrange to sneak into an ultrasound clinic and have a sympathetic technician figure out the sex of the baby inside. There are also genetic means for determining sex which are becoming easier and more affordable. Sex specific abortion, the actual procedure, is also illegal in India and China, and so a significant proportion of such abortions are done unsafely, risking the life of the mother. Women who can't afford an abortion often take pills or poisons to end their pregnancy, risking not only their own health but the health of their baby should it survive. Clearly most women understand these risks, legal and physical, and still attempt to terminate their pregnancies. Ending this practice will take significant social change, including abandoning dowry practices and improving the status of women in the workplace.
It is possible to find some of the most interesting and cutting edge uses for ultrasound in the literature from developing countries because they have the equipment and, lacking CT scanners and x-ray machines, they have ample motivation to use it to its greatest advantage.
In India and China, however, which both need low cost alternatives for diagnosis and treatment, ultrasound use is regulated because of the common practice of using it to determine sex of the fetus and then to selectively abort female fetuses. In China, the one-child law combined with a preference for male children and led to female feticide and then laws to prohibit use of technology to determine the sex of the fetus before birth. Apparently the law is difficult to enforce and so sex specific feticide continues there. In India conservative estimates of the number of female fetuses aborted was about 250,000 per year. There are campaigns by the government to encourage valuing female children, but the economic and social reasons that the problem exists in the first place are at the very basis of the issue.
When a woman in India is married it is still traditional to offer the family of the groom a hefty dowry. There are laws against dowries but that doesn't seem to have changed the practice much. Women also work at jobs which are less prestigious than men and earn lower wages. At marriage, a woman customarily moves to the home of her husband and is no longer available to take care of her own parents. So girl children are expensive.
It is much cheaper to get an obstetrical ultrasound in India than in the US, but still very expensive in comparison to overall cost of living. Getting an abortion is also relatively inexpensive, but costs money, which poor families actually don't have. It is far less expensive to have the baby and abandon it or kill it, and female infanticide is also pretty common in India. An article in the Atlantic Monthly looked at this problem and some strategies to deal with it, such as safe places where babies can be left, no questions asked, for adoption or care.
General Electric Healthcare, the company that makes the tiny pocket ultrasound that I use, and also makes a full range of amazing ultrasound equipment, was severely criticized and was even in legal troubles regarding the perception that they were complicit in sex determination of fetuses. This file describes their experience. Apparently they are actively involved in trying to enforce Indian law and have, according to some of my contacts, been less willing to donate equipment in India, which they had done before. The manufacturers are legally responsible for how their equipment is used, per a 2004 change in the laws about prenatal sex discrimination.
It seems to me that the attempt to regulate use of ultrasound in order to reduce the abortion of female fetuses is doomed to complete failure. It is just too easy to do an ultrasound and see a fetus's genitalia. An economically motivated family certainly can arrange to sneak into an ultrasound clinic and have a sympathetic technician figure out the sex of the baby inside. There are also genetic means for determining sex which are becoming easier and more affordable. Sex specific abortion, the actual procedure, is also illegal in India and China, and so a significant proportion of such abortions are done unsafely, risking the life of the mother. Women who can't afford an abortion often take pills or poisons to end their pregnancy, risking not only their own health but the health of their baby should it survive. Clearly most women understand these risks, legal and physical, and still attempt to terminate their pregnancies. Ending this practice will take significant social change, including abandoning dowry practices and improving the status of women in the workplace.
Sunday, March 10, 2013
Apollo Munich Awarded a Silver in the Digiratti 2012 List
Apollo Munich bagged yet another award, a Silver in the Digiratti 2012 List by Paul Writer for Marketing Campaign of Optima Restore.
The Digiratti List by Paul Writer recognizes those campaigns that are benchmarks for Connected Marketing. This List aims to recognize the team that has created unique customer communities and used innovative social media, video, mobile and digital technology to increase marketing impact.
Apollo Munich won this Silver Award for its marketing theme 'Unbelievable' for memorability and retention - featuring hard-to-imagine acts performed by people from different parts of the world and for turning the company website upside down before the launch to create a buzz to draw trade and customers to the website for more information. This unusual concept successfully gained attention of majority of people. It created buzz in market by introducing truly innovative health insurance benefits.
Starting its journey in health insurance sector in the year 2007, Apollo Munich always came up with well designed healthcare products. Travelling through various twists and turns, it has been established as one of the best health insurance provider in India. The company has earned this recognition with consistent and concentrated efforts, innovative thinking, urge to offer the best in class services to the citizens of country. Having launched various different products like Easy Health, Maxima, Insure Health, Optima Cash, Optima Plus, Optima Restore, Optima Senior and Easy Travel insurance plan, it offers different insurance options to all. One can find insurance coverage as per the specific need. Amidst all the products, Optima Restore is inclusive of several unique health insurance benefits.
Talking about this unbelievable product, Antony Jacob, the CEO of Apollo Munich Health Insurance Company mentioned, “ Optima Restores is the first in the series of next generation products that we are planning to launch. It is based on our extensive research over the past 17 months and analysis of over 250 global products. ‘Optima Restore’ has been designed to offer complete comfort to health insurance consumers, since their coverage will increase whether they use up the plan or don’t use it at all. Guaranteed and with no extra charge.”
This plan is inclusive of other benefits like lifelong renewal, no claim based underwriting, no geography based sublimits, treatment on cashless basis across 4000 network hospitals, easy upgrade and certifies associates. With all such benefits Optima Restore offers comprehensive and beneficial coverage.
Due to its innovative features and benefits, the plan has been the choice of millions of people. The plan has been introduced to meet all healthcare needs of people without any compromise. Drawing a good response from market, Optima Restore has proved its success and effective working. With its launch, Restore sold a record number of policies. Involving basic insurance coverage features, it weaves along innovative insurance benefits to allow healthcare without any compromise. Having won awards for its innovative thought line, it has introduced first of its kind benefit. It achieved great success rate giving evidence of favourable response from people.
The creative thought has brought alive the idea of this unbelievable product. To makes people familiar with its concept, its advertising campaign’s focus was to bring alive this truth, positioning Optima Restore as the game changing product. Its promotional videos draw attention towards the unbelievable facts. It highlights the unusual activities performed by people that are rare to find. It directly relates to the product Optima Restore that brings unusual benefits at easy access.
Optima Restore adheres to its tagline of ‘Unbelievable’. It is a plan power packed with first of its kind benefit that makes the policy coverage comprehensive and beneficial at affordable insurance premium. Framed in sum insured options ranging from 3 lakh to 15 lakhs, the plan can be purchased as both individual and family health plan.
The Digiratti List by Paul Writer recognizes those campaigns that are benchmarks for Connected Marketing. This List aims to recognize the team that has created unique customer communities and used innovative social media, video, mobile and digital technology to increase marketing impact.
Apollo Munich won this Silver Award for its marketing theme 'Unbelievable' for memorability and retention - featuring hard-to-imagine acts performed by people from different parts of the world and for turning the company website upside down before the launch to create a buzz to draw trade and customers to the website for more information. This unusual concept successfully gained attention of majority of people. It created buzz in market by introducing truly innovative health insurance benefits.
Starting its journey in health insurance sector in the year 2007, Apollo Munich always came up with well designed healthcare products. Travelling through various twists and turns, it has been established as one of the best health insurance provider in India. The company has earned this recognition with consistent and concentrated efforts, innovative thinking, urge to offer the best in class services to the citizens of country. Having launched various different products like Easy Health, Maxima, Insure Health, Optima Cash, Optima Plus, Optima Restore, Optima Senior and Easy Travel insurance plan, it offers different insurance options to all. One can find insurance coverage as per the specific need. Amidst all the products, Optima Restore is inclusive of several unique health insurance benefits.
Talking about this unbelievable product, Antony Jacob, the CEO of Apollo Munich Health Insurance Company mentioned, “ Optima Restores is the first in the series of next generation products that we are planning to launch. It is based on our extensive research over the past 17 months and analysis of over 250 global products. ‘Optima Restore’ has been designed to offer complete comfort to health insurance consumers, since their coverage will increase whether they use up the plan or don’t use it at all. Guaranteed and with no extra charge.”
This plan is inclusive of other benefits like lifelong renewal, no claim based underwriting, no geography based sublimits, treatment on cashless basis across 4000 network hospitals, easy upgrade and certifies associates. With all such benefits Optima Restore offers comprehensive and beneficial coverage.
Due to its innovative features and benefits, the plan has been the choice of millions of people. The plan has been introduced to meet all healthcare needs of people without any compromise. Drawing a good response from market, Optima Restore has proved its success and effective working. With its launch, Restore sold a record number of policies. Involving basic insurance coverage features, it weaves along innovative insurance benefits to allow healthcare without any compromise. Having won awards for its innovative thought line, it has introduced first of its kind benefit. It achieved great success rate giving evidence of favourable response from people.
The creative thought has brought alive the idea of this unbelievable product. To makes people familiar with its concept, its advertising campaign’s focus was to bring alive this truth, positioning Optima Restore as the game changing product. Its promotional videos draw attention towards the unbelievable facts. It highlights the unusual activities performed by people that are rare to find. It directly relates to the product Optima Restore that brings unusual benefits at easy access.
Optima Restore adheres to its tagline of ‘Unbelievable’. It is a plan power packed with first of its kind benefit that makes the policy coverage comprehensive and beneficial at affordable insurance premium. Framed in sum insured options ranging from 3 lakh to 15 lakhs, the plan can be purchased as both individual and family health plan.
Friday, March 8, 2013
Innovation Award for Optima Restore
Optima Restore is a truly innovative product launched by Apollo Munich Health Insurance
in recent past. Based on the concept of ‘Unbelievable’, the plan incorporates several unique features to serve people with unique healthcare benefits. Soon after its launch, the product captured the attention of large number of audience thereby receiving a good response.
Optima Restore became the choice of majority of people with its unbelievable benefits. The plan is inclusive of basic coverage features along with a long list of innovative insurance benefits that makes the plan unique.
In a very short time, Optima Restore became the choice of many people. For developing upon such unique concept, this plan has bagged below listed awards
in recent past. Based on the concept of ‘Unbelievable’, the plan incorporates several unique features to serve people with unique healthcare benefits. Soon after its launch, the product captured the attention of large number of audience thereby receiving a good response.
Optima Restore became the choice of majority of people with its unbelievable benefits. The plan is inclusive of basic coverage features along with a long list of innovative insurance benefits that makes the plan unique.
In a very short time, Optima Restore became the choice of many people. For developing upon such unique concept, this plan has bagged below listed awards
- India Insurance Awards for Best Product Innovation Award category
- ‘Innovation of the Year’ award at the Asia Insurance Industry Awards
- Innovation Award by Finnoviti in the Insurance Sector for an unbelievable product
Having received all such awards, Optima Restore has been evident of the innovative healthcare coverage it offers to its clients.
There are numerous health insurance products available in the market. They are ready to serve people with comprehensive health insurance coverage. Formulated as per the needs of people, the policies are flexible enough to fit into the framed of varied healthcare needs. Amidst all of them stands Optima Restore- an unbelievable health plan. The plan is based on the unique concept so as to serve people with never before benefits in health insurance industry. It is a plan that entitles the insured not only to comprehensive coverage but also to innovative health insurance benefits at affordable cost.
Optima Restore offers you basic sum insured options ranging from 3 lakhs to 15 lakhs. It allow the individual to pick the plan as per the affordability. The buyer can decide according to the premium he/ she can afford to pay. Moreover, the policy is equipped with a feature like ‘Multiplier Benefit’. There are several plans that might be offering no claim bonus but Optima Restore offers it in different packaging. This benefit multiplies the sum insured in case the insured does not make the claim. It entitles him/ her to a no claim discount of 50% increase in the insurance amount for having a claim free year. But here comes an added advantage, if the policy holder does not apply for claim even in the second year, it will double the basic sum insured making it 100% of the insurance amount. With no extra charge or any complicated paperwork, Apollo Munich serve people with this unique benefit.
In addition to this, this innovative health insurance policy makes the insured entitled to yet another ‘Restore Benefit’. Pertaining to this feature the policy automatically reinstates the entire sum insured amount if the insured uses it in a policy year. This provision is of true help for insured individuals, especially if the plan is purchased as family health plan. If the coverage amount has been utilized once, it doesn’t keep other insured members away from using the coverage amount once again. With the coverage amount restored, other members can once again claim the policy coverage for best healthcare coverage. Hence, the plan lives up to its promise of taking good care of all the covered members.
Taking a close view of the plan, Optima Restore can be truly recognized as an innovative health insurance plan. Having earned the trust of millions of people, it has served many people with its unique health insurance benefits. So, get yourself covered under such a unique health plan and enjoy unbelievable medical insurance benefit.
There are numerous health insurance products available in the market. They are ready to serve people with comprehensive health insurance coverage. Formulated as per the needs of people, the policies are flexible enough to fit into the framed of varied healthcare needs. Amidst all of them stands Optima Restore- an unbelievable health plan. The plan is based on the unique concept so as to serve people with never before benefits in health insurance industry. It is a plan that entitles the insured not only to comprehensive coverage but also to innovative health insurance benefits at affordable cost.
Optima Restore offers you basic sum insured options ranging from 3 lakhs to 15 lakhs. It allow the individual to pick the plan as per the affordability. The buyer can decide according to the premium he/ she can afford to pay. Moreover, the policy is equipped with a feature like ‘Multiplier Benefit’. There are several plans that might be offering no claim bonus but Optima Restore offers it in different packaging. This benefit multiplies the sum insured in case the insured does not make the claim. It entitles him/ her to a no claim discount of 50% increase in the insurance amount for having a claim free year. But here comes an added advantage, if the policy holder does not apply for claim even in the second year, it will double the basic sum insured making it 100% of the insurance amount. With no extra charge or any complicated paperwork, Apollo Munich serve people with this unique benefit.
In addition to this, this innovative health insurance policy makes the insured entitled to yet another ‘Restore Benefit’. Pertaining to this feature the policy automatically reinstates the entire sum insured amount if the insured uses it in a policy year. This provision is of true help for insured individuals, especially if the plan is purchased as family health plan. If the coverage amount has been utilized once, it doesn’t keep other insured members away from using the coverage amount once again. With the coverage amount restored, other members can once again claim the policy coverage for best healthcare coverage. Hence, the plan lives up to its promise of taking good care of all the covered members.
Taking a close view of the plan, Optima Restore can be truly recognized as an innovative health insurance plan. Having earned the trust of millions of people, it has served many people with its unique health insurance benefits. So, get yourself covered under such a unique health plan and enjoy unbelievable medical insurance benefit.
Saturday, March 2, 2013
Recycling the community physician: how should we really be training the next generation of doctors?
I have been spending time at an academic medical center lately and I’m noticing some obvious flaws in our method of shaping the doctors of the future. When I went to medical school I was trained by physicians who were eminent in their areas of specialty and also did some research. They taught in classrooms and as attending physicians when we were working on the wards as doctors in training. I realize now that the clinical attendings who helped us manage our general medical patients actually specialized in some more narrow aspect of medicine, but were smart enough to be able to manage a diverse array of medical problems. I thought they were all amazing and never even entertained the possibility that their knowledge was less than exhaustive. I was also taught by the interns and residents who were themselves in training, though with an MD after their names. I thought that they were both wise and skillful. Perhaps they were. I will never find out now.
Watching the training of medical students this last month, I am appreciative of the skills and scholarship of many of their teaching attendings, but also am noticing that there is a difference between a physician who has spent his or her time entirely at an academic medical institution and a good community physician. The academic physician is nearly forced by the proximity of educational lectures and the demands of teaching to keep current on the recommended treatments for various diseases. They also rely heavily on the expertise of consultants in everything from dermatology to cardiology and gynecology, so don’t necessarily have a good grounding in treating a whole person in the community and circumstances in which that person finds himself. In practice, it would not have been unusual for me to treat someone for their depression, congestive heart failure, obesity, cough and the rash on their legs. In fact, all of these problems were probably connected and required an approach that recognized the other issues.
I was also hanging out in a university hospital’s emergency department some of the time, which was fascinating and sometimes really hard to watch. After saving the patients who required that acutely and sending a subset of them to the wards for admission and further treatment, there were patients who had issues that required a subtle or clever approach, which was not really in the knowledge set of the ER physicians. Not that it necessarily should be, since emergency physicians should really be dealing with emergencies. Still. Many of the patients who use emergency rooms do so because they cannot be refused service there for inability to pay, and they can be seen the day they show up, though they may have to wait many hours. Although their non-emergency problems should be taken care of by doctors in the community, they don’t have doctors in the community, and sometimes, if they do, those doctors are not particularly skillful.
So I think that academic medical centers need physicians who have been in practice to teach medical students. Physicians who have been in practice also need academic medical centers to remind them to keep their knowledge bases updated and give them a reason and a method for doing so. Academic physicians are very intelligent and hard working, but much of their brain space is taken up with their research projects and many or even most of them have never had to take care of as many patients for as long as those of us in practice have, and so they are not ideally suited to teach medical students how to practice medicine. It would be nice to see some cross pollination between medical schools and non-teaching institutions. Community physicians do act as preceptors for medical students, taking them to clinic and on rounds, but this is just a small fraction of the medical students’ learning and is not coordinated with teaching objectives.
It was probably nearly the same when I was a medical student, but I never noticed, other than realizing when I got out of medical school that there was still lots to learn. One thing that was significantly different when I was in training was that in the 3rd and 4thyears of medical school we had very important clinical responsibilities. Without us, patients would have died and residents would have been frantically overworked. We drew bloods, we wrote progress notes, we started IV’s, delivered drugs and blood products. We were at the bottom of the food chain, but we were part of it. We were called “scut monkeys” because of the number of menial tasks for which we were responsible for. Now medical students have been mostly eliminated from jobs that are vital to patient care. They have restrictions on work hours, which is kind of good and kind of not so good. They can spend all day trying to find learning experiences, but are also seen as kind of a nuisance because they have no really important role. When they get their MD’s and become residents, they have all the responsibilities all of a sudden since the medical students don’t help that much. I think I was observing some of the more unpleasant results of burnout in some of the residents as they were deluged with work that they weren’t really prepared to do. Their fatigue impacted attending physicians who were required to do more than they comfortably could handle, thus reducing their ability and willingness to teach.
In some of the hospitals where I have worked consultants or representatives of hospital organizations have come in to identify work processes that are ineffective or inefficient. This is necessary in places that are not heavily subsidized (and academic medical centers are pretty heavily subsidized.) I sense that this focus on efficiency is not necessarily a part of academic hospitals, though my single recent experience is hardly an exhaustive survey. HealthGrades released a list of the top 5% of hospitals in the US in terms of patient outcomes and patient satisfaction and it is not surprising to me that very few primarily academic medical centers made the list. UC San Francisco is not on the list. Neither is Johns Hopkins, Massachusetts General Hospital, the Brigham and Women’s Hospital or the University of Washington. This may have something to do with the fact that they provide services to very sick and often uninsured patients, but I don't think that is all of it. The processes at the university hospital where I have just recently been hanging out are very haphazard compared to other good hospitals in my recent experience. Some well thought out process changes could free up huge amounts of wasted energy in a place like this, which would likely make both residents and attendings have more time for teaching and good patient care. Perhaps medical students could even be brought back into the team as an underutilized labor source.
Thursday, February 21, 2013
How to perform a fecal transplant--why make this so very difficult?
Fecal transplant, thanks to the recent article in the New England Journal of Medicine out of the Netherlands, has made it to the front page, the big time. In my inbox today was a link to a how-to article from medscape from a doctor from Eastern Virginia Medical School who apparently does the occasional fecal transplant for recurrent Clostridium difficile colitis.
In this article, the author says that one must do $500 worth of testing on the donor, then make up a particle free stool slurry of stool and non-bacteriostatic saline under a hood (due to the biohazard aspects of making poop soup) filter it and instill the mixture via a colonoscope to the patient who has taken 3 gallons of polyethylene glycol solution and preferably had only clear liquids for 2 days. He says that the procedure should only be done for patients who have had Clostridium difficile for 3 months which has not responded to antibiotic therapy.
There is no evidence to suggest that giving donor feces by colonoscopy is any better than giving it by low volume enema, at home, or by nasogastric tube. Colonoscopy carries significant risks: anesthesia is risky and colonoscopes can cause perforation and bleeding. Colonoscopies are expensive. The recent article in the New England Journal used a naso-duodenal tube, not a colonoscope.
There is reasonable evidence that fecal transplant is effective for treatment of ulcerative colitis, an autoimmune disease of the colon that causes chronic disability, colon cancer and internal bleeding. Acute Clostridium difficile claims many lives, and there is abundant experience of treating it with fecal transplant. Limiting this therapy to chronic cases seems a bit excessively restrictive.
The author of the medscape article notes that some of the patients in the recent trial of fecal microbiota transplantation developed new diseases, some of them autoimmune, which might have been related to the transplants. It seems unlikely, but I would also wonder whether some of the patients found that more problems than just their Clostridium difficile were resolved. Much is still not known and will only be revealed as more research is done with larger groups of patients.
As far as the $500 of tests that need to be done on the donor, I wonder if perhaps some of these could be eliminated. Clearly the donor should be checked for body fluid transmitted diseases such as HIV and hepatitis, though a family donor of known low risk (a child, for instance) might safely be presumed to be uninfected. Extensive stool testing for bacteria and parasites in a donor with no intestinal difficulties might also be unnecessary, especially if that person's history was well known.
As far as the actual logistics of delivering donor stool to recipient colon, I suspect nothing more than a commercially available enema bag and tubing would be necessary. The soup to be delivered could probably be easily and cleanly mixed up in a ziplock bag, with no need for a blender. As far as preparation with a clear liquid diet and gallons of polyethylene glycol, I am curious to see evidence that supports this (I don't think there is any, yet). Cleaning out the bad bugs seems like a good approach, but patients get very weak after a standard colonoscopy prep so a prep that includes days of fasting plus more polyethylene glycol might lead to its own problems.
I am starting to think about the nuts and bolts of all of this because, as a hospital physician, I will soon be faced with a patient for whom fecal transplant will be an obvious life saving intervention, and I will have to figure out how to do it with as little fuss as possible. It will be unethical for me to allow someone to die when antibiotics fail, as they so often do, when evidence shows that a fecal enema would probably be curative.
In this article, the author says that one must do $500 worth of testing on the donor, then make up a particle free stool slurry of stool and non-bacteriostatic saline under a hood (due to the biohazard aspects of making poop soup) filter it and instill the mixture via a colonoscope to the patient who has taken 3 gallons of polyethylene glycol solution and preferably had only clear liquids for 2 days. He says that the procedure should only be done for patients who have had Clostridium difficile for 3 months which has not responded to antibiotic therapy.
There is no evidence to suggest that giving donor feces by colonoscopy is any better than giving it by low volume enema, at home, or by nasogastric tube. Colonoscopy carries significant risks: anesthesia is risky and colonoscopes can cause perforation and bleeding. Colonoscopies are expensive. The recent article in the New England Journal used a naso-duodenal tube, not a colonoscope.
There is reasonable evidence that fecal transplant is effective for treatment of ulcerative colitis, an autoimmune disease of the colon that causes chronic disability, colon cancer and internal bleeding. Acute Clostridium difficile claims many lives, and there is abundant experience of treating it with fecal transplant. Limiting this therapy to chronic cases seems a bit excessively restrictive.
The author of the medscape article notes that some of the patients in the recent trial of fecal microbiota transplantation developed new diseases, some of them autoimmune, which might have been related to the transplants. It seems unlikely, but I would also wonder whether some of the patients found that more problems than just their Clostridium difficile were resolved. Much is still not known and will only be revealed as more research is done with larger groups of patients.
As far as the $500 of tests that need to be done on the donor, I wonder if perhaps some of these could be eliminated. Clearly the donor should be checked for body fluid transmitted diseases such as HIV and hepatitis, though a family donor of known low risk (a child, for instance) might safely be presumed to be uninfected. Extensive stool testing for bacteria and parasites in a donor with no intestinal difficulties might also be unnecessary, especially if that person's history was well known.
As far as the actual logistics of delivering donor stool to recipient colon, I suspect nothing more than a commercially available enema bag and tubing would be necessary. The soup to be delivered could probably be easily and cleanly mixed up in a ziplock bag, with no need for a blender. As far as preparation with a clear liquid diet and gallons of polyethylene glycol, I am curious to see evidence that supports this (I don't think there is any, yet). Cleaning out the bad bugs seems like a good approach, but patients get very weak after a standard colonoscopy prep so a prep that includes days of fasting plus more polyethylene glycol might lead to its own problems.
I am starting to think about the nuts and bolts of all of this because, as a hospital physician, I will soon be faced with a patient for whom fecal transplant will be an obvious life saving intervention, and I will have to figure out how to do it with as little fuss as possible. It will be unethical for me to allow someone to die when antibiotics fail, as they so often do, when evidence shows that a fecal enema would probably be curative.
Monday, February 18, 2013
Bacteriophage therapy, biome reconstitution, heparin--potential scientific breakthroughs plagued by un-coolness
During the last year I have been paying particular attention to lesser known and under appreciated miracles in medicine. It is a mystery why miracles of any sort would be under appreciated, but it is so very human to ignore things in plain sight which disrupt our deeply held belief systems or even are simply not what we are looking for.
For those readers who don't believe that they could actually ignore something that is both true and in plain sight, I refer to this YouTube video, a classic experiment in selective attention. If that is not enough, there is a study in the journal Psychological Science (just reported in the popular press yesterday) which shows that radiologists looking for cancer failed to see a very obvious and ridiculous image on a chest x-ray.
I would propose, also, that we are even more likely to ignore information if that information is uncool. Things that are cool make us feel indestructible and things that are uncool make us feel weak or embarrassed or out of place. Olympic snow boarders, action movie heroes and dancing flawlessly in high heels are cool. Sexually transmitted diseases, urinary incontinence and broccoli between the teeth are uncool. In medicine, heart transplants, miracle drugs and prosthetic joints are cool. Here are a few things that we really do not hear much about at all, despite the fact that they are inspiring, potentially paradigm changing and have been around for years.
Bacteriophage Therapy:
Researchers have been aware of tiny viruses which kill bacteria since the late 1800's. Early on it was not clear that these elements were alive, and it was not proven until decades later that they were, in fact, viruses. In any environment where bacteria naturally grow, bacteriophage live as well, and they can be separated from the bacteria experimentally by using a fine porcelain filter. The water we drink contains phages, since purification is not designed to remove them and they are innocuous. When phages are deliberately grown with bacteria, we can isolate them in concentrations that can be used to treat bacterial infections. In the 1940's, before antibiotics were commercially available, phages were produced in the US by the Eli Lilly company. As early as 1919 phages were used to treat children with severe dysentery, and in the 1920's thousands of people with cholera were treated with it. When antibiotics became more widely available, phage therapy dwindled in popularity. A scientific paper written in 1934 questioning its utility was another nail in the coffin. Reviewing this paper in the light of what is known now, it is clear that its negative conclusions were heavily based on weak science. Phage research and therapy has continued to be actively pursued in Poland and the Republic of Georgia, but the kind of science we like in the US, the double blind placebo controlled trials, have not been done. There are papers comparing antibiotics to phages, which are compelling and generally show phages to be significantly more effective. Phages have been given orally, topically, intravenously, in the eye, intraperitoneally, in large doses, to humans and to laboratory animals with essentially no toxicity. Producing phages is easy, since they can be isolated from a bacterial broth with a filter which is not much different from what we backpackers use to pump safe water from mountain streams. When bacteria become resistant to a phage it is simple to create another phage that is effective for that bacteria. Phages and bacteria evolve constantly in nature in just that way.
It is clear that now that broad spectrum antibiotics are losing the war against resistant bacteria and that their overuse is creating huge problems for us, not to mention their expense and myriad side effects, we need to look seriously at using bacteriophages therapeutically. The US is not, however, geared up to do this at all. Drug companies are not interested, since they don't have the equipment and, since phages are living organisms, they can't get exclusive rights to market them. Universities and research institutions could take up the ball, and there are bacteriophage projects ongoing, but they are hardly able to bring this to full production capability. It is at least theoretically an advantage to use a mixture of phages to treat infection. It would be very difficult to accurately characterize a diverse population of phages which would hamper approval processes.
Also, bacteriophages are quintessentially uncool. The main research institutions which produce phages are the Eliava Institute in Georgia and the Hirszfeld Institute in Poland. Much of the research was done by the former Soviet Union. Eastern Europe is, at least to scientists, basically uncool. We don't understand their language, we don't trust their methods, we are uncomfortable with their culture. A major source of therapeutic and experimental bacteriophage isolated at the Eliava Institute is the polluted river which runs through Tbilisi, the capitol of Georgia. Sewage is uncool. Phages have been around for years and still we don't use them. Obviously they must not be effective. We worry that we might be duped into believing that something is effective when it is not, which would be very uncool. Scads of research, though not scrupulously done, strongly suggests that bacteriophage therapy works. (See link for an excellent review article.)
Biome reconstitution and fecal transplant:
I have written several times about fecal transplant, most recently after the publication in the New England Journal of Medicine of an article out of the Netherlands showing a clear superiority of instilling healthy donor stool in the intestines of patients over use of antibiotics for Clostridium Difficile colitis. Various ailments of the colon, and possibly even obesity may be caused by alterations in the flora of the lower intestines and may be effectively treated by adding an appropriate bacteriological community. The use of healthy poop to cure disease of the colon is probably ancient, and has been in our medical literature since the 1950's. Research has shown it to be staggeringly effective, working within days and resulting in long lasting effectiveness with only one treatment.
In the first decade of this millenium, good research out of Duke University suggested that losing helminths (worms) from our guts due to improved sanitation has been responsible for various diseases of autoimmunity, including allergies, inflammatory bowel disease and maybe multiple sclerosis. There is even a possible connection with autism. There is some good research showing improvements in Crohn's disease and Ulcerative Colitis by reintroducing helminths.
I would suggest that giving people worms and introducing poop soup into the intestines by way of a tube is icky and uncool, which may be why we are so very hesitant to take up this kind of therapy even though it appears to be cheap, elegant and effective. Fecal bacteria and intestinal worms are unlikely to be heavily marketed by drug companies, upon whom we have often depended for the impetus to make major therapeutic changes. These are not things which will make anybody much money, which means that researchers, physicians, hospitals and patients will have to push for them.
The very expression "fecal transplant" is at least giggle, if not gag inducing. The term "biome reconstitution" is much cooler and should probably be the term we use, so perhaps we can get past being grossed out and move forward towards helping sick people get well.
Heparin for burns and wounds:
I have written about this at least a couple of times after being introduced to the concept about a year ago. Heparin is a naturally occurring biological molecule released from mast cells at the site of vascular injury. It is isolated naturally from the livers of pigs or cows and is used to prevent clotting. It is in every hospital formulary and has been a mainstay of therapy for clotting disorders for decades. It has anti-inflammatory and healing properties as well, which are undoubtedly relevant naturally and can be useful therapeutically. One of its main proponents in its use to treat burns and skin ulcers is Dr. Michael Saliba who first did animal experiments with it for this purpose over 40 years ago. Although articles have been published on its efficacy, it has never taken hold in the US for burn treatment, despite the fact that it dramatically reduces pain and scarring. There is quite a bit of research showing that it is effective, but it is difficult to do controlled trials since the caregivers treating the patients can pretty easily tell if their patients are not having pain. I did some little experiments using it for wounds and now have it in any first aid kit because it works so much better than anything else I've used. I, however, am not in any position to do controlled trials.
Heparin will never make anyone any money, since it has been around forever and works just fine in the 1:5000 concentration vials that are easily and cheaply available at any hospitals. Its main proponents are Dr. Saliba who is a family practitioner with an interest in burns and a very cool research project as a medical student, and many burn doctors who are non-English speakers and don't publish in our most prestigious journals. Protocols for its use are at his website which is very user friendly but looks hokey and makes a person think that there is some proprietary aspect to heparin for burns and that maybe its effectiveness is overstated. Heparin for burns is probably awesome, effective and inexpensive and failed to catch on because it will not financially benefit anyone and for various reasons it suffers the stigma of uncoolness.
Over centuries, though, many uncool concepts have eventually found enough support to become commonly believed truth. Copernicus (whose birthday is today) proposed that the sun held still and the earth and planets revolved around it. His idea was so unthinkable that he delayed publishing it for years and was even hesitant to discuss it with other scholars. It took over a hundred years for heliocentrism to be commonly accepted. It took only 5 years from the time a mother of two children with acute arthritis in Lyme Connecticut contacted her health department with concerns about a possible infectious cause until an effective antibiotic was found for Lyme disease in 1980. Dr. Robin Warren first saw helicobacter pylori in stomachs in 1979, established its role in causing stomach ulcers with his colleague Dr. Barry Marshall, was ridiculed for years and won the Nobel Prize for his work in 2005.
Researchers and clinicians will eventually legitimize good, effective treatments for terrible diseases even if those treatments are presently not adequately sexy to receive notice. The "truth will out" as they say. It is presently frustrating, though, to watch the glacially slow speed with which this is happening.
For those readers who don't believe that they could actually ignore something that is both true and in plain sight, I refer to this YouTube video, a classic experiment in selective attention. If that is not enough, there is a study in the journal Psychological Science (just reported in the popular press yesterday) which shows that radiologists looking for cancer failed to see a very obvious and ridiculous image on a chest x-ray.
I would propose, also, that we are even more likely to ignore information if that information is uncool. Things that are cool make us feel indestructible and things that are uncool make us feel weak or embarrassed or out of place. Olympic snow boarders, action movie heroes and dancing flawlessly in high heels are cool. Sexually transmitted diseases, urinary incontinence and broccoli between the teeth are uncool. In medicine, heart transplants, miracle drugs and prosthetic joints are cool. Here are a few things that we really do not hear much about at all, despite the fact that they are inspiring, potentially paradigm changing and have been around for years.
Bacteriophage Therapy:
Researchers have been aware of tiny viruses which kill bacteria since the late 1800's. Early on it was not clear that these elements were alive, and it was not proven until decades later that they were, in fact, viruses. In any environment where bacteria naturally grow, bacteriophage live as well, and they can be separated from the bacteria experimentally by using a fine porcelain filter. The water we drink contains phages, since purification is not designed to remove them and they are innocuous. When phages are deliberately grown with bacteria, we can isolate them in concentrations that can be used to treat bacterial infections. In the 1940's, before antibiotics were commercially available, phages were produced in the US by the Eli Lilly company. As early as 1919 phages were used to treat children with severe dysentery, and in the 1920's thousands of people with cholera were treated with it. When antibiotics became more widely available, phage therapy dwindled in popularity. A scientific paper written in 1934 questioning its utility was another nail in the coffin. Reviewing this paper in the light of what is known now, it is clear that its negative conclusions were heavily based on weak science. Phage research and therapy has continued to be actively pursued in Poland and the Republic of Georgia, but the kind of science we like in the US, the double blind placebo controlled trials, have not been done. There are papers comparing antibiotics to phages, which are compelling and generally show phages to be significantly more effective. Phages have been given orally, topically, intravenously, in the eye, intraperitoneally, in large doses, to humans and to laboratory animals with essentially no toxicity. Producing phages is easy, since they can be isolated from a bacterial broth with a filter which is not much different from what we backpackers use to pump safe water from mountain streams. When bacteria become resistant to a phage it is simple to create another phage that is effective for that bacteria. Phages and bacteria evolve constantly in nature in just that way.
It is clear that now that broad spectrum antibiotics are losing the war against resistant bacteria and that their overuse is creating huge problems for us, not to mention their expense and myriad side effects, we need to look seriously at using bacteriophages therapeutically. The US is not, however, geared up to do this at all. Drug companies are not interested, since they don't have the equipment and, since phages are living organisms, they can't get exclusive rights to market them. Universities and research institutions could take up the ball, and there are bacteriophage projects ongoing, but they are hardly able to bring this to full production capability. It is at least theoretically an advantage to use a mixture of phages to treat infection. It would be very difficult to accurately characterize a diverse population of phages which would hamper approval processes.
Also, bacteriophages are quintessentially uncool. The main research institutions which produce phages are the Eliava Institute in Georgia and the Hirszfeld Institute in Poland. Much of the research was done by the former Soviet Union. Eastern Europe is, at least to scientists, basically uncool. We don't understand their language, we don't trust their methods, we are uncomfortable with their culture. A major source of therapeutic and experimental bacteriophage isolated at the Eliava Institute is the polluted river which runs through Tbilisi, the capitol of Georgia. Sewage is uncool. Phages have been around for years and still we don't use them. Obviously they must not be effective. We worry that we might be duped into believing that something is effective when it is not, which would be very uncool. Scads of research, though not scrupulously done, strongly suggests that bacteriophage therapy works. (See link for an excellent review article.)
Biome reconstitution and fecal transplant:
I have written several times about fecal transplant, most recently after the publication in the New England Journal of Medicine of an article out of the Netherlands showing a clear superiority of instilling healthy donor stool in the intestines of patients over use of antibiotics for Clostridium Difficile colitis. Various ailments of the colon, and possibly even obesity may be caused by alterations in the flora of the lower intestines and may be effectively treated by adding an appropriate bacteriological community. The use of healthy poop to cure disease of the colon is probably ancient, and has been in our medical literature since the 1950's. Research has shown it to be staggeringly effective, working within days and resulting in long lasting effectiveness with only one treatment.
In the first decade of this millenium, good research out of Duke University suggested that losing helminths (worms) from our guts due to improved sanitation has been responsible for various diseases of autoimmunity, including allergies, inflammatory bowel disease and maybe multiple sclerosis. There is even a possible connection with autism. There is some good research showing improvements in Crohn's disease and Ulcerative Colitis by reintroducing helminths.
I would suggest that giving people worms and introducing poop soup into the intestines by way of a tube is icky and uncool, which may be why we are so very hesitant to take up this kind of therapy even though it appears to be cheap, elegant and effective. Fecal bacteria and intestinal worms are unlikely to be heavily marketed by drug companies, upon whom we have often depended for the impetus to make major therapeutic changes. These are not things which will make anybody much money, which means that researchers, physicians, hospitals and patients will have to push for them.
Heparin for burns and wounds:
I have written about this at least a couple of times after being introduced to the concept about a year ago. Heparin is a naturally occurring biological molecule released from mast cells at the site of vascular injury. It is isolated naturally from the livers of pigs or cows and is used to prevent clotting. It is in every hospital formulary and has been a mainstay of therapy for clotting disorders for decades. It has anti-inflammatory and healing properties as well, which are undoubtedly relevant naturally and can be useful therapeutically. One of its main proponents in its use to treat burns and skin ulcers is Dr. Michael Saliba who first did animal experiments with it for this purpose over 40 years ago. Although articles have been published on its efficacy, it has never taken hold in the US for burn treatment, despite the fact that it dramatically reduces pain and scarring. There is quite a bit of research showing that it is effective, but it is difficult to do controlled trials since the caregivers treating the patients can pretty easily tell if their patients are not having pain. I did some little experiments using it for wounds and now have it in any first aid kit because it works so much better than anything else I've used. I, however, am not in any position to do controlled trials.
Heparin will never make anyone any money, since it has been around forever and works just fine in the 1:5000 concentration vials that are easily and cheaply available at any hospitals. Its main proponents are Dr. Saliba who is a family practitioner with an interest in burns and a very cool research project as a medical student, and many burn doctors who are non-English speakers and don't publish in our most prestigious journals. Protocols for its use are at his website which is very user friendly but looks hokey and makes a person think that there is some proprietary aspect to heparin for burns and that maybe its effectiveness is overstated. Heparin for burns is probably awesome, effective and inexpensive and failed to catch on because it will not financially benefit anyone and for various reasons it suffers the stigma of uncoolness.
Over centuries, though, many uncool concepts have eventually found enough support to become commonly believed truth. Copernicus (whose birthday is today) proposed that the sun held still and the earth and planets revolved around it. His idea was so unthinkable that he delayed publishing it for years and was even hesitant to discuss it with other scholars. It took over a hundred years for heliocentrism to be commonly accepted. It took only 5 years from the time a mother of two children with acute arthritis in Lyme Connecticut contacted her health department with concerns about a possible infectious cause until an effective antibiotic was found for Lyme disease in 1980. Dr. Robin Warren first saw helicobacter pylori in stomachs in 1979, established its role in causing stomach ulcers with his colleague Dr. Barry Marshall, was ridiculed for years and won the Nobel Prize for his work in 2005.
Researchers and clinicians will eventually legitimize good, effective treatments for terrible diseases even if those treatments are presently not adequately sexy to receive notice. The "truth will out" as they say. It is presently frustrating, though, to watch the glacially slow speed with which this is happening.
Subscribe to:
Posts (Atom)
