When I started practice 30 years ago, it was assumed that the family doctor knew his patients well, that he/she had their best interests at heart, and that the patient communicated his/her final wishes about the desired manner of death to us (no hospital, or no resuscitation, or shock but no intubation and placing on a respirator, or no feeding tube by naso-gastric or PEG, etc.), and we mutually understood what "no heroic measures" meant.
Now, however, "dying will" laws have been passed, all of which assume a priori, that the doctor and the patient are total strangers to one another, and that the doctor does not have the patient's best interests at heart. The results have only placed family members under extreme emotional burden to make decisions that they were never trained to make, and will probably feel guilty about, either way. There is a reason that doctors should not take care of their families, because of lack of emotional distance, but it is assumed that the spouse and/or the children have enough emotional distance to "pull the plug" with no problems. And often, after they have made their heart-rending decision about terminating life support, the hospital "ethics committee", with little more training than good will, will often ask them to justify their decisions. It seems to me that if you do not trust your doctor to make an ethical life-and-death decision about your existence in conjunction with you, then it is time to find another doctor.
I would like to tell you about several terminal cases with which I was involved, so that you can compare what happened in the past to what is happening today. I have an office in one state, but admit patients to a hospital in another state where I am a medical attending with teaching and admitting privileges. I am, of course, licensed in both states.
30 years ago, before hospice, I had a number of elderly patients who were irreversibly dying at home,and had no wish to ever enter a hospital again. (This was before the days of hospice). One gentleman had metastatic multiple myeloma as well as COPD, but he had all his faculties and wished to stay in the nursing home and finish his life there. This he did, and was made comfortable by increasing doses of IV morphine, to sedate his anxious breathing. Refusing intubation or hospital admission, he received increasingly higher doses of oxygen and morphine, until he then died peacefully, not agitated or gasping for breath. He had no immediate family.
Another patient had esophageal carcinoma, and a PEG feeding tube into his stomach through which he was given Ensure and other high-protein drinks. When I came, I poured 2 oz. of Johnny Walker Black into the tube, and he swore he could taste and feel it. He also died at home, without a 911 call.
The next patient had hepatocellular (liver) cancer, and recurrent ascites. He also insisted on remaining at home. I came by weekly to tap his abdomen, which interfered with his breathing if it got too filled with fluid (ascites), but since effusive ascites is protein rich, I had to be sure to replace the lost protein.
Another patient had inoperable wide-open mitral regurgitation, and she also was treated at home for a number of months.
Then the laws changed: The nursing homes were fined $5,000/day if they did not report to the state ombundsman any patient that they thought might die without hospital admission. And unless the patient had a Do-Not-Resuscitate form stapled to his forehead, the EMT's always did a "full-court press", whether the patient wanted it or not. In fact I had had a patient with stage IV breast cancer with bilateral pleural effusions,
and the family agreed not to call 911 if she passed out (her wishes). A neighbor called 911, and although I told the EMT's on the scene that I had a valid DNR order in my office, I was in one state, they were in another, and unless I could fax them the DNR immediately., they were going to intubate her immediately and transfer her to their hospital. They did so, and she lived to 10 days on a respirator in the ICU, which was not what she wanted.
I had a patient with terminal Parkinson's Disease and Alzheimer's Disease;. The family and I agreed to support him with fluids by clysis. The nursing home filed a report to the state ombundsman who demanded the operative replacement of a PEG tube in the stomach. I admitted the patient to my (only) admitting hospital in another state, where he died peacefully ten days later. The state ombundsman accused me and the patient's son of transferring the patient to another state to avoid his jurisdiction, and I was forced to have the Medical Society's lawyer point out that that was the only hospital (at that time) to which I had admitting privileges.
The worst case of recent memory involved a male patient. He stated quite clearly in his living will that he wanted "no heroic measures", and "not a life as a vegetable". His wife did not agree with his point of view, so he appointed his three children jointly as executors of his medical well. (Of course the son from California, i.e.the one who saw his father the least, had the greatest objections to pulling the plug.) It took the three children 10-14 agonizing (and I do mean agonizing ) days to make the decision to end life support, and then the operating surgeon insisted that this decision be referred to the hospital ethics committee, who finally agreed with the children, all of whom were emotionally wrung out and barely speaking with their mother when the ordeal was over.
So now we are glad to turn all these problems over to the hospitalists, who do not know the patients very well, but they do know the rules of the state, of the federal government, the ethics committee, and the hospital.
Let me close with a story that does not cast glory on the hospital political system. When open heart surgery was first performed, the heart-lung machine needed 20 units of blood from different donors to have enough volume to work efficiently. At that time, we had not discovered Hepatitis C (which can be fatal through progressive cirrhosis or the induction of hepatocellular cancer). We could test for hepatitis with Anti-A and anti-B antibodies, so when patients got hepatitis after heart surgery, we would call it "non-A, non-B hepatitis", to mask our lack of knowledge. Lancet published an article demonstrating that if their open-heart patients received massive doses of pooled gamma globulin just before and just after cardiac surgery, it sharply lessened their chances of getting non-A, non-B hepatitis. (Clearly the pooled gamma globulins must have had antibodies against the new hepatitis.) Since I took rigid care of my patients even on the open-heart surgery floor (I admitted them, in order to maintain some sense of control and feedback) I decided to give them 2cc's of pooled gamma globulin directly before surgery, and on return to the recovery room. NONE of my patients developed Non-A non-B hepatitis.
But then the head of Infectious Disease called me into his office, saying that no other doctor did this. I explained my rationale, and showed that my patients did better. He said that was beside the point,that it would "not look good" if I was the only doctor doing this, no matter how well my patients did, and that I should stop doing it. I responded that I saved lives. His only response was to place IV gamma globulin under ID control, so I could not order it for my patients without ID approval which, of course, was never granted for open-heart surgery patients.
If the government would just leave doctors and patients alone, we could take much better care of them.
Sunday, November 28, 2010
Thursday, November 18, 2010
Deaths after Chiropractic
I seem to be sending out warnings lately. This latest came to me from Medscape, which quoted an article from the International Journal of Clinical Studies. I had heard of similar studies earlier. Apparently there is a risk that chiropractic manipulation of the neck can lead to acute dissection of the vertebral artery, stroke, and death. The majority of these events occur in patients younger than 40 years.
The link to the abstract of the article (see Medscape for fuller details) can be seen at PubMed:
www.ncbi.nlm.nih.gov/pubmed/20642715
The danger seems to be in acute rotation of the neck, since this is done without an MRA study of the vertebral arteries.
The link to the abstract of the article (see Medscape for fuller details) can be seen at PubMed:
www.ncbi.nlm.nih.gov/pubmed/20642715
The danger seems to be in acute rotation of the neck, since this is done without an MRA study of the vertebral arteries.
Wednesday, November 17, 2010
OTC Phenypropylamine---increased stroke risk
A friend of mine forwarded me a brief letter which I feel deserves the widest possible circulation.
There were originally two over-the-counter (vascular) decongestants that were sold for relief of the symptoms of the common cold: phenylpropylamine, and pseudoephedrine. Of the two, phenylpropylamine was observed to cause a more severe vascular constriction in the cerebral circulation, and a statistically significant increase in the incidence of strokes in patients NOT OTHERWISE AT CVA RISK was noted. This was of especial significance in women and children, and so gradually fewer and fewer OTC "cold pills" contained phenylpropylamine. For instance, the popular decongestant Sudafed contained only pseudoephedrine.
Several years ago, the government noted that bathtub chemists were "cooking" psudoephedrine (with acetone, I think) to make methamphetamine, aka "speed" or "crank". The government therefore strongly discouraged the use of OTC pseudoephedrine, and now in some states it is kept behind the drug store's counter, or you have to sign for it, or the amount you can buy is limited.
However, post-marketing studies, as reported in the FDA's surveillance bulletin, have again noticed an increase in strokes associated with the use of phenylpropylamine. Therefore I have send a letter to all of my patients: DISCARD ALL COLD TABLETS CONTAINING PHENYLPROPYLAMINE, and never buy such tablets, either OTC or by prescription. This warning also applies to nasal sprays.
I would hope all my readers follow this advice (and please check with your doctors to notify them of your action and your reason for it).
The FDA link is: http://www.fda.gov/cder/druginfopage/ppa
There were originally two over-the-counter (vascular) decongestants that were sold for relief of the symptoms of the common cold: phenylpropylamine, and pseudoephedrine. Of the two, phenylpropylamine was observed to cause a more severe vascular constriction in the cerebral circulation, and a statistically significant increase in the incidence of strokes in patients NOT OTHERWISE AT CVA RISK was noted. This was of especial significance in women and children, and so gradually fewer and fewer OTC "cold pills" contained phenylpropylamine. For instance, the popular decongestant Sudafed contained only pseudoephedrine.
Several years ago, the government noted that bathtub chemists were "cooking" psudoephedrine (with acetone, I think) to make methamphetamine, aka "speed" or "crank". The government therefore strongly discouraged the use of OTC pseudoephedrine, and now in some states it is kept behind the drug store's counter, or you have to sign for it, or the amount you can buy is limited.
However, post-marketing studies, as reported in the FDA's surveillance bulletin, have again noticed an increase in strokes associated with the use of phenylpropylamine. Therefore I have send a letter to all of my patients: DISCARD ALL COLD TABLETS CONTAINING PHENYLPROPYLAMINE, and never buy such tablets, either OTC or by prescription. This warning also applies to nasal sprays.
I would hope all my readers follow this advice (and please check with your doctors to notify them of your action and your reason for it).
The FDA link is: http://www.fda.gov/cder/druginfopage/ppa
Sunday, November 14, 2010
Dabigatran: a replacement for Coumadin and Lovenox?
The results of the RE-LY study were just published in the New England Journal of Medicine. Since this blog is for both doctors and patients, I will try to split the difference in medical info. The article discussed a brand new anti-coagulant, dabigatran, which will be marketed here in the U.S. under the trade name Pradaxa, and is a pill to be taken twice a day.
The drug blocks the action of thrombin, which takes part in the final step of the clotting cascade. Thrombin converts fibrinogen to insoluble fibrin, which then makes a blood clot solid and tenacious.
The greatest risk factor for forming a clot is relative stasis of the blood flow next to the wall of a blood vessel. This clotting possibility is enhanced by some (unknown ) chemicals secreted by some cancers, especially prostate, as well as prolonged immobility, such as flying across the Atlantic Ocean.
The initial oral anti-coagulant was Coumadin (actually Warfarin, which was developed as a rat-killer by the University of Wisconsin from a chemical component of hay) which prevents blood from clotting, and so the rat bleeds to death internally. When Coumadin is given to humans, weekly blood tests are needed: a PT, as well as a monthly Hct. There is a narrow therapeutic window for Coumadin: too much and the patient can develop a GI or an intracranial bleed, and too little and the patient's blood will clot where it is not supposed to. If the patient finds the bleeding risk psychologically intolerable, oral alternatives are aspirin, and aspirin + dipyrimadole (Aggrenox). Under many circumstances, injectable low molecular weight heparin (e.g. Lovenox) can be used; this requires no blood tests for monitoring, but the patient has to inject him/herself daily.
This particular study compared oral dabigatran to oral Coumadin in patients with non-valvular atrial fibrillation. In this condition, the left atrium quivers like the surface of a bowl of jelly rather than contracting rhythmically. The blood flow against the left atrium wall is relatively static, and clots can form in the left atrium which then break loose and can go up to the brain, causing a stroke. Coumadin has been shown to sharply reduce the risk of this event, and aspirin will also reduce the stroke risk, but less so. The study showed that the risk of stroke as well as the risk of bleeding was lower with dabigatran than with Coumadin, and the FDA has approved the use of this drug for patients with non-valvular atrial fibrillation.
I doubt that this study will ever be repeated, so let us assume (and hope) that the conclusion reached is a correct one. The question then becomes: will dabigatran be used for other medical problems where Coumadin or aspirin is indicated, without going through a formal study? This is called an off-label use, but is neither illegal nor immoral. For instance, once it was found serendipidously that calcium channel blockers (used for hypertension and angina control) also reduced the frequency of migraine headaches, it was frequently prescribed for this purpose.
So now we have an anticoagulant that causes less bleeding than Coumadin in therapeutic doses (I am unaware of any bleeding studies vis-a-vis aspirin), need no weekly blood tests, and can be taken orally. I can think offhand of many medical problems where this drug might be useful.
In no particular order they are:
1) Cross-Atlantic flying----no studies of aspirin have shown reduction in the incidence of deep vein leg thrombosis.
2) Heart valve replacement---instead of Coumadin.
3) Post-op, especially in orthopedic procedures such as total hip or knee replacement
4) Any deep vein thrombosis
5) Any pulmonary embolus
6) Pulmonary hypertension, baggy heart with EF less than 20%, migraine headaches
7) Post-MI to reduce the risk of a second MI, instead of aspirin
8) (Unknown as yet) Patients with the need for anti-coagulation who have relative contra-indications such as erosive esophagitis, gastric ulcers, or duodenal ulcers
9) ? Patients with the lupus anticoagulant
10) Patients with factor V or Leiden problems
11) Patients with polycythemia or polythrombocytosis
12) Patients with TIA or embolic stroke
13)? Patients with any cancer who develop a deep vein thrombosis
etc., etc., etc.
Please feel free to post any other suggestions.
The drug blocks the action of thrombin, which takes part in the final step of the clotting cascade. Thrombin converts fibrinogen to insoluble fibrin, which then makes a blood clot solid and tenacious.
The greatest risk factor for forming a clot is relative stasis of the blood flow next to the wall of a blood vessel. This clotting possibility is enhanced by some (unknown ) chemicals secreted by some cancers, especially prostate, as well as prolonged immobility, such as flying across the Atlantic Ocean.
The initial oral anti-coagulant was Coumadin (actually Warfarin, which was developed as a rat-killer by the University of Wisconsin from a chemical component of hay) which prevents blood from clotting, and so the rat bleeds to death internally. When Coumadin is given to humans, weekly blood tests are needed: a PT, as well as a monthly Hct. There is a narrow therapeutic window for Coumadin: too much and the patient can develop a GI or an intracranial bleed, and too little and the patient's blood will clot where it is not supposed to. If the patient finds the bleeding risk psychologically intolerable, oral alternatives are aspirin, and aspirin + dipyrimadole (Aggrenox). Under many circumstances, injectable low molecular weight heparin (e.g. Lovenox) can be used; this requires no blood tests for monitoring, but the patient has to inject him/herself daily.
This particular study compared oral dabigatran to oral Coumadin in patients with non-valvular atrial fibrillation. In this condition, the left atrium quivers like the surface of a bowl of jelly rather than contracting rhythmically. The blood flow against the left atrium wall is relatively static, and clots can form in the left atrium which then break loose and can go up to the brain, causing a stroke. Coumadin has been shown to sharply reduce the risk of this event, and aspirin will also reduce the stroke risk, but less so. The study showed that the risk of stroke as well as the risk of bleeding was lower with dabigatran than with Coumadin, and the FDA has approved the use of this drug for patients with non-valvular atrial fibrillation.
I doubt that this study will ever be repeated, so let us assume (and hope) that the conclusion reached is a correct one. The question then becomes: will dabigatran be used for other medical problems where Coumadin or aspirin is indicated, without going through a formal study? This is called an off-label use, but is neither illegal nor immoral. For instance, once it was found serendipidously that calcium channel blockers (used for hypertension and angina control) also reduced the frequency of migraine headaches, it was frequently prescribed for this purpose.
So now we have an anticoagulant that causes less bleeding than Coumadin in therapeutic doses (I am unaware of any bleeding studies vis-a-vis aspirin), need no weekly blood tests, and can be taken orally. I can think offhand of many medical problems where this drug might be useful.
In no particular order they are:
1) Cross-Atlantic flying----no studies of aspirin have shown reduction in the incidence of deep vein leg thrombosis.
2) Heart valve replacement---instead of Coumadin.
3) Post-op, especially in orthopedic procedures such as total hip or knee replacement
4) Any deep vein thrombosis
5) Any pulmonary embolus
6) Pulmonary hypertension, baggy heart with EF less than 20%, migraine headaches
7) Post-MI to reduce the risk of a second MI, instead of aspirin
8) (Unknown as yet) Patients with the need for anti-coagulation who have relative contra-indications such as erosive esophagitis, gastric ulcers, or duodenal ulcers
9) ? Patients with the lupus anticoagulant
10) Patients with factor V or Leiden problems
11) Patients with polycythemia or polythrombocytosis
12) Patients with TIA or embolic stroke
13)? Patients with any cancer who develop a deep vein thrombosis
etc., etc., etc.
Please feel free to post any other suggestions.
Monday, November 8, 2010
Medical Beliefs and Medical Treatment
There have been many articles recently both in the medical and lay press urging patients to take better care of themselves: lose weight, exercise, eat "healthy" foods, stop smoking, don't drink to excess, etc. The problem with compliance with this or any other medical advice (take your prescribed medicine daily, please get a colonoscopy) is that if the advice does not fit in with the patient's mental model of disease, it won't be followed. I always allow 45 to 60 minutes for the first visit, so I can explore with the patient his/her model of disease.
The problem with patients' following any medical advice is that the human brain is designed to react to immediate problems, and not those predicted to happen 20 years down the road. We also have magical beliefs about our health, and sometimes are too eager to follow the latest health fad without examining the scientific data behind the recommendations. We all have heard of the remark made by a Greek mathematical tutor to Alexander the Great : "There is no royal (i.e. shortcut) road to education", but we do not realize that this applies to taking care of ourselves medically, as well.
Without sounding prejudicial, because I have seen many unpredicted beneficial reactions to many treatments (last month an elderly male patient of mine had his shoulder repaired, and afterwards his problems with his prostate disappeared), I must remind my readers that "alternative" medicine is another way of saying "unproven" medicine, although some alternative treatments do work on some patients.
Vegetarianism is an interesting belief. All animal cells need vitamin B-12 to create the nuclei of new cells, and no vegetable cells do. In fact, if you are a strict vegetarian (meaning no milk, fish or eggs, etc.) then you will die from pernicious anemia in 3 to 5 years from lack of vitamin B-12, and may sustain irreversible damage to your brain cells or peripheral nerves before you die. In addition, there are eight "essential" amino acids, in that unless your food contains all eight, you cannot make new protein. All animal meals contain these eight, of course, but no vegetable does. This is why traditional vegetarian meals must contain two different kinds of vegetables: rice and beans, corn and green peas (aka "succotash), etc. Furthermore, autopsy of the oldest human skeletons, when we were just meat-eaters, shows no evidence of tooth decay. Once we started to farm, and eat more carbohydrates, then dental caries appeared in autopsies.
Some examples of past and present beliefs (again I am only saying that there is no rational evidence in favor of a defined belief, not that it is necessarily incorrect):
Frontal lobotomies to cure schizophrenia, induced insulin shock to cure schizophrenia or epilepsy, bleeding to treat various diseases , purgatives to remove "poisons", high colonic enemas to cleanse oneself out, magnets in your shoes or on your belt to cure an aching back, copper bracelets to cure arthritis, staples in the earlobe to reduce appetite, eye exercises to improve myopia, chewing your food 20-100 times before swallowing it, an hour of sleep before midnight is worth two after midnight, a certain number of bowel movements a day or per week is necessary for good health, if you swallow fruit seeds you will grow bushes in your stomach, brown eggs are healthier than white eggs, raw (un-pasteurized) milk is healthier and safer, intravenous chelation therapy to remove harmful metals, removal of mercury fillings to de-toxify your body, fluoridated water is dangerous to your health,-----.
The way to test any of these beliefs on yourself is to alternately follow the advice and then completely ignore it either for one week or one month at a time. In that way you can determine what makes you feel better.
Other beliefs are more subtle. Yes, we all know we should lose weight, but few people believe that losing weight is beneficial enough to one's health to go through the discomfort of actually doing it. We all generally feel better after exercise ("runner's high") due to the generation of endorphins, but rarely do we make exercise part of our regular ritual. Furthermore, if we abstain for two weeks, there tends to be tremendous inertia against restarting exercise. We all believe that cigarettes are harmful, but no one believes that the one they are smoking at this instant will be fatal. We know that exceeding the speed limit is dangerous, but we do it so often that it becomes meaningless to us.
Many men believe that you are sick only if a doctor tells you that you are sick, so if you never see a doctor, then you are never sick. (This is one reason so many men become depressed after a heart attack---their system of denial has visibly failed.) Everyone believes that the less medicine you take, the less sick you are, so most patients try periodically to taper their medicines, often without checking with the doctor. Many patients absolutely refuse to have a colonoscopy, and some even refuse to do the stool- for- blood test. Some men are anxious to have a cardiac stress test, and some absolutely refuse. Meanwhile, many wives come with their husbands into the consultation room to make sure their husbands tell me the truth, and some even come into the exam room. Often a husband comes in asking for a stress test because his wife asked him to. When you dine in a restaurant if you will often hear wives telling their husbands what to eat, how much to eat, and what not to eat---again the man and his wife have different beliefs about food.
What I am trying to say in all the above is that it is generally fruitless to try to argue a patient out of his/her medical belief system, because it is rarely rational. I can sometimes get a patient to try it my way for one month, and then make an informed decision as to whether or not they feel better, but a spouse's medical advice is generally doomed to failure. Sometimes, a patient knows what the "right" medical thing is to do, but for various subconscious reasons just refuses to do it. They even will admit that they "should" do this or that, but they won't. Just recall how difficult it was to get your two-year-old child to eat spinach, and then extrapolate to the refusal an adult can mount.
Finally, please remember Freud's dictum that the ego cannot conceive of its own non-existence, i.e. of its own death.
The problem with patients' following any medical advice is that the human brain is designed to react to immediate problems, and not those predicted to happen 20 years down the road. We also have magical beliefs about our health, and sometimes are too eager to follow the latest health fad without examining the scientific data behind the recommendations. We all have heard of the remark made by a Greek mathematical tutor to Alexander the Great : "There is no royal (i.e. shortcut) road to education", but we do not realize that this applies to taking care of ourselves medically, as well.
Without sounding prejudicial, because I have seen many unpredicted beneficial reactions to many treatments (last month an elderly male patient of mine had his shoulder repaired, and afterwards his problems with his prostate disappeared), I must remind my readers that "alternative" medicine is another way of saying "unproven" medicine, although some alternative treatments do work on some patients.
Vegetarianism is an interesting belief. All animal cells need vitamin B-12 to create the nuclei of new cells, and no vegetable cells do. In fact, if you are a strict vegetarian (meaning no milk, fish or eggs, etc.) then you will die from pernicious anemia in 3 to 5 years from lack of vitamin B-12, and may sustain irreversible damage to your brain cells or peripheral nerves before you die. In addition, there are eight "essential" amino acids, in that unless your food contains all eight, you cannot make new protein. All animal meals contain these eight, of course, but no vegetable does. This is why traditional vegetarian meals must contain two different kinds of vegetables: rice and beans, corn and green peas (aka "succotash), etc. Furthermore, autopsy of the oldest human skeletons, when we were just meat-eaters, shows no evidence of tooth decay. Once we started to farm, and eat more carbohydrates, then dental caries appeared in autopsies.
Some examples of past and present beliefs (again I am only saying that there is no rational evidence in favor of a defined belief, not that it is necessarily incorrect):
Frontal lobotomies to cure schizophrenia, induced insulin shock to cure schizophrenia or epilepsy, bleeding to treat various diseases , purgatives to remove "poisons", high colonic enemas to cleanse oneself out, magnets in your shoes or on your belt to cure an aching back, copper bracelets to cure arthritis, staples in the earlobe to reduce appetite, eye exercises to improve myopia, chewing your food 20-100 times before swallowing it, an hour of sleep before midnight is worth two after midnight, a certain number of bowel movements a day or per week is necessary for good health, if you swallow fruit seeds you will grow bushes in your stomach, brown eggs are healthier than white eggs, raw (un-pasteurized) milk is healthier and safer, intravenous chelation therapy to remove harmful metals, removal of mercury fillings to de-toxify your body, fluoridated water is dangerous to your health,-----.
The way to test any of these beliefs on yourself is to alternately follow the advice and then completely ignore it either for one week or one month at a time. In that way you can determine what makes you feel better.
Other beliefs are more subtle. Yes, we all know we should lose weight, but few people believe that losing weight is beneficial enough to one's health to go through the discomfort of actually doing it. We all generally feel better after exercise ("runner's high") due to the generation of endorphins, but rarely do we make exercise part of our regular ritual. Furthermore, if we abstain for two weeks, there tends to be tremendous inertia against restarting exercise. We all believe that cigarettes are harmful, but no one believes that the one they are smoking at this instant will be fatal. We know that exceeding the speed limit is dangerous, but we do it so often that it becomes meaningless to us.
Many men believe that you are sick only if a doctor tells you that you are sick, so if you never see a doctor, then you are never sick. (This is one reason so many men become depressed after a heart attack---their system of denial has visibly failed.) Everyone believes that the less medicine you take, the less sick you are, so most patients try periodically to taper their medicines, often without checking with the doctor. Many patients absolutely refuse to have a colonoscopy, and some even refuse to do the stool- for- blood test. Some men are anxious to have a cardiac stress test, and some absolutely refuse. Meanwhile, many wives come with their husbands into the consultation room to make sure their husbands tell me the truth, and some even come into the exam room. Often a husband comes in asking for a stress test because his wife asked him to. When you dine in a restaurant if you will often hear wives telling their husbands what to eat, how much to eat, and what not to eat---again the man and his wife have different beliefs about food.
What I am trying to say in all the above is that it is generally fruitless to try to argue a patient out of his/her medical belief system, because it is rarely rational. I can sometimes get a patient to try it my way for one month, and then make an informed decision as to whether or not they feel better, but a spouse's medical advice is generally doomed to failure. Sometimes, a patient knows what the "right" medical thing is to do, but for various subconscious reasons just refuses to do it. They even will admit that they "should" do this or that, but they won't. Just recall how difficult it was to get your two-year-old child to eat spinach, and then extrapolate to the refusal an adult can mount.
Finally, please remember Freud's dictum that the ego cannot conceive of its own non-existence, i.e. of its own death.
Wednesday, October 27, 2010
Medication, Prescribing, and Timing
There is an important variable that arises in pharmacology that is rarely addressed: after the choice of an antibiotic, how often a day should it be given, what time of day should it be given, and how do doctors compensate for the fact most patients stop antibiotics before the prescribed time period is up?
Sometimes we just don't know, sometimes we forget that patients stop almost all Rx's too early, and sometimes published clinical results are not followed because they are not in the PDR. One concrete example is malaria prophylaxis. Many of the drugs have to be continued for one to four weeks after the patient leaves the malarious area, and many patients forget about the fourth week. My practice is to have the pharmacist label the bottle: "Take.........until the bottle is empty", and then I emphasize to the patient the importance of following this advice.
If you prescribe antibiotics to be taken three times a day, you are fooling yourself, because most patients forget the midday dose, and only in the hospital can you depend on this schedule being followed (by the floor nurse, not the patient). Just ask your residents the next time you see them how well they complied the last time they were prescribed antibiotics. That is one reason I rather prescribe Augmentin, which can be overkill, rather than Amoxicillin, because the former is 2x/day, the the latter 3x/day. For the same reason I prefer Ceftin at b.i.d. to Keflex, especially when treating abscesses, where constant penetration at a bactericidal level is critical and, occasionally, once a day Levaquin to twice a day Cipro, even though the latter is available as a generic.
A classic study was done at NY Presbyterian's pediatric clinic about 40 years ago. Mothers were prescribed the classic bottle of liquid (yellow) penicillin suspension, with the instructions to give their child 1 tsp. four times a day, and warned about the strep throat/rheumatic fever connection. When the mothers returned with their bottles in 10 days, only 10% of them had empty bottles. Assuming that none emptied the bottles that AM out of embarrassment, this means that at least 90% of the most vitally interested persons did not follow the instructions. Add to this the belief of most patients that the less medicine they take the less sick they are helps us to understand why intelligent drug companies prescribe an antibiotic for longer than is necessary (e.g. 3 days of Zithromax is generally equipotent to 5 days, because of its persistence in the necessary tissues and cells) in order to be sure of observing a positive effect.
We all are aware that as the blood sugar climbs above 200, blood becomes more of a non-Newtonian fluid with an atypical cross-sectional velocity profile, and an enlarged viscosity-dependent boundary layer, so that Schlichting's classical theory does not apply. Two well-known results from this are (a) reduced diapedesis of white blood cells, thereby lessening resistance to containing infection, and (b) a non-linear increase in the pressure required to drive blood through the circulatory system, thereby increasing the amount of heart failure. But does the level of blood sugar affect the bactericidal effect of antibiotics? This question is not answered for most antibiotics, which is unfortunate, because diabetics have difficulty controlling the fasting and the post-prandial glucose level equally well, and that should therefore determine the optimum time of the day to deliver a once daily or twice daily antibiotic.
As far as I am aware, although some anti-cancer drugs are tested AM vs. PM to look for a diurnal variation effect, no antibiotic has been. We do know that for some antibiotics the peak level is important, for others the trough, and for still others the area under the dose-time curve, but it is difficult to translate these results into concepts the patient can understand. And the question of with food or on an empty stomach is often answered theoretically rather than clinically. For instance, does it really matter if Synthroid is taken before or after breakfast so long as the patient is consistent by taking the medicine at the same time each day, to reduce the variation of the blood free T4 level? Should a daily antibiotic be given in the AM, when the serum cortisol is at a peak, or in the PM, when the serum iron is at its peak? One could make a case for AM dosing, because one way the body apparently fights infection is to lower the serum iron, but I am unaware of any studies on this possible effect.
Another important point is to make sure certain drugs are dispensed only in tablet rather than capsule form. This is especially important when prescribing Doxycycline, since if a capsule with a pH of 12 gets stuck in the esophagus and dissolves there, the resulting chemical burn can take two to three weeks to heal. I also routinely give skiers the sunburn warning, because if snow blindness is of concern, then so is sunburn, especially on the lips.
The problem of generics also should be addressed (and I realize that I am drifting from my main topic). The generic and the brand name drug are usually compounded differently, with different binders and dyes to make up the tablet. I have seen several cases where the allergic reaction of the patient was due to the binders or the drug-carrying vehicle, and not to the parent antibiotic or drug, e.g. in a reaction to an IM steroid given to treat an acute allergic reaction.
We still do not know the optimum length of time to treat acute sinusitis or acute otitis media or acute cystitis or acute prostatitis. ENT physicians seem to add a Medrol Dospak to any infection they treat above the neck, and we internists do not, but I am not aware of any definitive comparative studies on this subject, nor does it appear in the Cochrane Report. We don't know if we should treat sub-acute Lyme disease for 14 or 21 days, but if you are concerned over malpractice, then 21 days always wins out.
And despite our encouragement NOT to treat viral infections, and the awareness of the public of the problem of drug resistance, I can tell you that if my wife gets a URI and she is not treated, the number of friends who tell her to see another doctor (not myself in either case) so she can get "put on an antibiotic and be properly treated" is astronomical.
Let me close with a related anecdotal story. When I was an intern in NYC, I admitted a male alcoholic with pneumonia one freezing December PM. We put him straightaway into the ICU because of trilobar pneumonia (in those days the admitting intern also covered his patients in the ICU with the help of the ICU resident, not the ward resident). The patient died within 12 hours of admission, and I filled out the death certificate: "Cause of Death...Acute Pneumonia". The supervising ward manager called me down to his office, telling me that in NYC if the death certificate did not specify either viral or bacterial pneumonia, then it became a ME case due to health law, and the body could not be released to the family for burial until an autopsy was performed to determine if a virus or a bacterium was responsible for the death. He asked me to insert an adjective for the family's sake, and I did. So much for the accuracy of death certificates---patients and their families can and should take priority over accurate facts under certain conditions.
Sometimes we just don't know, sometimes we forget that patients stop almost all Rx's too early, and sometimes published clinical results are not followed because they are not in the PDR. One concrete example is malaria prophylaxis. Many of the drugs have to be continued for one to four weeks after the patient leaves the malarious area, and many patients forget about the fourth week. My practice is to have the pharmacist label the bottle: "Take.........until the bottle is empty", and then I emphasize to the patient the importance of following this advice.
If you prescribe antibiotics to be taken three times a day, you are fooling yourself, because most patients forget the midday dose, and only in the hospital can you depend on this schedule being followed (by the floor nurse, not the patient). Just ask your residents the next time you see them how well they complied the last time they were prescribed antibiotics. That is one reason I rather prescribe Augmentin, which can be overkill, rather than Amoxicillin, because the former is 2x/day, the the latter 3x/day. For the same reason I prefer Ceftin at b.i.d. to Keflex, especially when treating abscesses, where constant penetration at a bactericidal level is critical and, occasionally, once a day Levaquin to twice a day Cipro, even though the latter is available as a generic.
A classic study was done at NY Presbyterian's pediatric clinic about 40 years ago. Mothers were prescribed the classic bottle of liquid (yellow) penicillin suspension, with the instructions to give their child 1 tsp. four times a day, and warned about the strep throat/rheumatic fever connection. When the mothers returned with their bottles in 10 days, only 10% of them had empty bottles. Assuming that none emptied the bottles that AM out of embarrassment, this means that at least 90% of the most vitally interested persons did not follow the instructions. Add to this the belief of most patients that the less medicine they take the less sick they are helps us to understand why intelligent drug companies prescribe an antibiotic for longer than is necessary (e.g. 3 days of Zithromax is generally equipotent to 5 days, because of its persistence in the necessary tissues and cells) in order to be sure of observing a positive effect.
We all are aware that as the blood sugar climbs above 200, blood becomes more of a non-Newtonian fluid with an atypical cross-sectional velocity profile, and an enlarged viscosity-dependent boundary layer, so that Schlichting's classical theory does not apply. Two well-known results from this are (a) reduced diapedesis of white blood cells, thereby lessening resistance to containing infection, and (b) a non-linear increase in the pressure required to drive blood through the circulatory system, thereby increasing the amount of heart failure. But does the level of blood sugar affect the bactericidal effect of antibiotics? This question is not answered for most antibiotics, which is unfortunate, because diabetics have difficulty controlling the fasting and the post-prandial glucose level equally well, and that should therefore determine the optimum time of the day to deliver a once daily or twice daily antibiotic.
As far as I am aware, although some anti-cancer drugs are tested AM vs. PM to look for a diurnal variation effect, no antibiotic has been. We do know that for some antibiotics the peak level is important, for others the trough, and for still others the area under the dose-time curve, but it is difficult to translate these results into concepts the patient can understand. And the question of with food or on an empty stomach is often answered theoretically rather than clinically. For instance, does it really matter if Synthroid is taken before or after breakfast so long as the patient is consistent by taking the medicine at the same time each day, to reduce the variation of the blood free T4 level? Should a daily antibiotic be given in the AM, when the serum cortisol is at a peak, or in the PM, when the serum iron is at its peak? One could make a case for AM dosing, because one way the body apparently fights infection is to lower the serum iron, but I am unaware of any studies on this possible effect.
Another important point is to make sure certain drugs are dispensed only in tablet rather than capsule form. This is especially important when prescribing Doxycycline, since if a capsule with a pH of 12 gets stuck in the esophagus and dissolves there, the resulting chemical burn can take two to three weeks to heal. I also routinely give skiers the sunburn warning, because if snow blindness is of concern, then so is sunburn, especially on the lips.
The problem of generics also should be addressed (and I realize that I am drifting from my main topic). The generic and the brand name drug are usually compounded differently, with different binders and dyes to make up the tablet. I have seen several cases where the allergic reaction of the patient was due to the binders or the drug-carrying vehicle, and not to the parent antibiotic or drug, e.g. in a reaction to an IM steroid given to treat an acute allergic reaction.
We still do not know the optimum length of time to treat acute sinusitis or acute otitis media or acute cystitis or acute prostatitis. ENT physicians seem to add a Medrol Dospak to any infection they treat above the neck, and we internists do not, but I am not aware of any definitive comparative studies on this subject, nor does it appear in the Cochrane Report. We don't know if we should treat sub-acute Lyme disease for 14 or 21 days, but if you are concerned over malpractice, then 21 days always wins out.
And despite our encouragement NOT to treat viral infections, and the awareness of the public of the problem of drug resistance, I can tell you that if my wife gets a URI and she is not treated, the number of friends who tell her to see another doctor (not myself in either case) so she can get "put on an antibiotic and be properly treated" is astronomical.
Let me close with a related anecdotal story. When I was an intern in NYC, I admitted a male alcoholic with pneumonia one freezing December PM. We put him straightaway into the ICU because of trilobar pneumonia (in those days the admitting intern also covered his patients in the ICU with the help of the ICU resident, not the ward resident). The patient died within 12 hours of admission, and I filled out the death certificate: "Cause of Death...Acute Pneumonia". The supervising ward manager called me down to his office, telling me that in NYC if the death certificate did not specify either viral or bacterial pneumonia, then it became a ME case due to health law, and the body could not be released to the family for burial until an autopsy was performed to determine if a virus or a bacterium was responsible for the death. He asked me to insert an adjective for the family's sake, and I did. So much for the accuracy of death certificates---patients and their families can and should take priority over accurate facts under certain conditions.
Friday, October 22, 2010
Medical Malpractice
The topic of medical malpractice and its cost in both premiums and extra medical tests has recently been discussed in various places, including the Op-Ed pages of the NY Times, but usually by non-doctors. As a practicing family MD (internist) who has been sued 5 times, (once as ward attending, once as hospital medical consultant, and three times for office visits) and who has had all three cases dismissed with prejudice (i.e. no trial, and no payment), let me describe to you non-doctors and non-sued doctors what is wrong with the system.
First, being sued does not make a doctor a better doctor. We improve through experience and studying, and not making the same mistake twice. But the ever-present threat of malpractice makes us more careful, in that most doctors ask themselves before any medical action: how will this look to 12 jurymen who are not doctors? And if a scenario similar to that which we were sued for ever re-occurs, even if we were dismissed, we make sure the same procedure is never followed, because who wants to be sued? An example is the fact that although the Virgin Islands has a Good Samaritan law for emergency treatment by physicians, a physician was sued for doing dockside CPR on a patient who eventually died. His case of course was dismissed because of the law, but the existence of the law did NOT protect him from being sued. He told the newspapers he will never offer emergency medical assistance to a stranger again, because he doesn't want to be sued.
As an example, I had a female patient with Hodgkin's disease, who was cured. For years, her gynecologist and I both urged her to get a colonoscopy, because people with one cancer are at higher risk for a second. There were seven years documented in both our charts of her refusal to get a colonoscopy, and she even refused to check annual stools for blood. When she died from metastatic colon cancer, her husband sued both me and the gynecologist for failure to diagnose the cancer. Again, this took a lot of time away from us. Both our cases were dismissed with prejudice. But the result is that I "fire" (i.e. discharge from my practice) any patient who refuses to do an annual stool for blood or a colonoscopy every 5 years, because again, who wants to be sued even if you win the case?
So now in addition to asking myself "what can the patient have that can damage or kill him/her if I do not diagnose it?" I also ask myself "What test can I be sued for not doing?". You see, a doctor is never sued for doing a test, but only for not doing it. So if a patient or spouse or relative asks for any test, I always say yes, which I never used to do, but that is what the system wants me to do. And it does no good to follow the "disease guidelines", because if you have a patient with 5 diseases (high blood pressure, GI reflux, heart failure, osteoporosis, and asthma) then some of the guidelines will conflict with others. In addition, the guidelines are not uniform: the USPHS, AMA, American Urological Association, American Cancer Association, and American College of Physicians, have widely differing guidelines on using the PSA test for prostate cancer, and even if it should be used at all.
I think it would reduce costs tremendously if the malpractice cases were taken out of the tort-contingency fee system, and put instead into the no-fault system, as is auto insurance in the State of New Jersey, where doctor's and lawyer's fees are set by the workmen's compensation fee schedule.
We also cannot practice medicine and keep notes as the lawyers would have us do, in part because we cannot bill for telephone time and making notes. We could certainly sharply reduce malpractice suits by telling every patient to either come into the office or go to the ER, and never renew any medicine or give any advice over the phone, because we can be sued for telephone advice. I also once flabbergasted a lawyer at a deposition; when he said "If you haven't written it down, you haven't done it", I answered "And what makes you think that if I did write it down I did do it?". For instance we all warn patients on sleeping pills to be careful when driving, but none of us forbid it. I know one doctor who photocopies the PDR warnings of every drug he prescribes, and gives one copy to the patient and puts the other in the chart.
Some results of the threat of malpractice: in at least two counties near Miami Fla., no neurosurgeon will cover the ER for automobile accidents; virtually no OB's teach or do forceps delivery, e.g. for a transverse lie, but proceed immediately to a C-section, and in 2 counties in Northern West Virginia there are no pediatricians, because they all moved northward across the river to a state with lower malpractice premiums. I was taught to tap the chest ("thoracentesis). In about 1% of the cases, in the best hands, there is a partial collapse of the lung (pneumothorax). So now all internists have pulmonologists or chest surgeons do it, because they do it more frequently, and therefore can defend against the incidence of pneumothorax more easily (and of course the chest surgeon charges more).
So now the doctor's mantra is not to avoid error, but to avoid being sued. This is not synonomous with practicing the best medicine. I even know some doctors who refuse to treat any lawyers or their families at all, just as many landlords in NYC refuse to rent to lawyers.
Again, every doctor wants to take the best possible care of his patient, but if 1/2500 infants is born with a birth defect, and 5% of aortic aneurysm repair patients die, and if 1% of hip replacements get infected, the doctor seems to get sued for every bad result. Although in theory the plaintiff has to show the doctor did something wrong, in practice the doctor has to show that he did everything right, and if he/she did, why was there a bad result? In American jurisprudience, if anyone has a bad result in anything, it is someone's fault (unless, of course you lose a lawsuit, and then it is never the lawyer's fault).
One final note: In NY State, they started keeping a record of the death rate for open heart surgeons (and later, their hospitals). The immediate result, as you might expect, is that cardiac surgeons took on fewer riskier cases where the patient has an estimated less than 10% chance of survival, no matter how the family pleads, because he doesn't want his death rate to go up. Several years ago there was a piteous Op-Ed piece about this in the NY Times, by a columnist who said it took him 10 days to find a cardiac surgeon willing to risk operating on his mother, and the surgery was not done at a major hospital teaching center.
I guess I should close with a repeat of a previous story. About 10 years ago, a California woman refused a pap smear for several years in a row, and her refusal was well-documented in the chart. When she died from cervical cancer, the husband sued the gynecologist. He convinced the jury that if the doctor had warned the patient properly, then any prudent patient would have agreed to the pap smear and found the cervical cancer. The jury agreed (!), and found against the GYN who now, of course, fires from his practice any woman who refuses an annual pap test or mammogram.
First, being sued does not make a doctor a better doctor. We improve through experience and studying, and not making the same mistake twice. But the ever-present threat of malpractice makes us more careful, in that most doctors ask themselves before any medical action: how will this look to 12 jurymen who are not doctors? And if a scenario similar to that which we were sued for ever re-occurs, even if we were dismissed, we make sure the same procedure is never followed, because who wants to be sued? An example is the fact that although the Virgin Islands has a Good Samaritan law for emergency treatment by physicians, a physician was sued for doing dockside CPR on a patient who eventually died. His case of course was dismissed because of the law, but the existence of the law did NOT protect him from being sued. He told the newspapers he will never offer emergency medical assistance to a stranger again, because he doesn't want to be sued.
As an example, I had a female patient with Hodgkin's disease, who was cured. For years, her gynecologist and I both urged her to get a colonoscopy, because people with one cancer are at higher risk for a second. There were seven years documented in both our charts of her refusal to get a colonoscopy, and she even refused to check annual stools for blood. When she died from metastatic colon cancer, her husband sued both me and the gynecologist for failure to diagnose the cancer. Again, this took a lot of time away from us. Both our cases were dismissed with prejudice. But the result is that I "fire" (i.e. discharge from my practice) any patient who refuses to do an annual stool for blood or a colonoscopy every 5 years, because again, who wants to be sued even if you win the case?
So now in addition to asking myself "what can the patient have that can damage or kill him/her if I do not diagnose it?" I also ask myself "What test can I be sued for not doing?". You see, a doctor is never sued for doing a test, but only for not doing it. So if a patient or spouse or relative asks for any test, I always say yes, which I never used to do, but that is what the system wants me to do. And it does no good to follow the "disease guidelines", because if you have a patient with 5 diseases (high blood pressure, GI reflux, heart failure, osteoporosis, and asthma) then some of the guidelines will conflict with others. In addition, the guidelines are not uniform: the USPHS, AMA, American Urological Association, American Cancer Association, and American College of Physicians, have widely differing guidelines on using the PSA test for prostate cancer, and even if it should be used at all.
I think it would reduce costs tremendously if the malpractice cases were taken out of the tort-contingency fee system, and put instead into the no-fault system, as is auto insurance in the State of New Jersey, where doctor's and lawyer's fees are set by the workmen's compensation fee schedule.
We also cannot practice medicine and keep notes as the lawyers would have us do, in part because we cannot bill for telephone time and making notes. We could certainly sharply reduce malpractice suits by telling every patient to either come into the office or go to the ER, and never renew any medicine or give any advice over the phone, because we can be sued for telephone advice. I also once flabbergasted a lawyer at a deposition; when he said "If you haven't written it down, you haven't done it", I answered "And what makes you think that if I did write it down I did do it?". For instance we all warn patients on sleeping pills to be careful when driving, but none of us forbid it. I know one doctor who photocopies the PDR warnings of every drug he prescribes, and gives one copy to the patient and puts the other in the chart.
Some results of the threat of malpractice: in at least two counties near Miami Fla., no neurosurgeon will cover the ER for automobile accidents; virtually no OB's teach or do forceps delivery, e.g. for a transverse lie, but proceed immediately to a C-section, and in 2 counties in Northern West Virginia there are no pediatricians, because they all moved northward across the river to a state with lower malpractice premiums. I was taught to tap the chest ("thoracentesis). In about 1% of the cases, in the best hands, there is a partial collapse of the lung (pneumothorax). So now all internists have pulmonologists or chest surgeons do it, because they do it more frequently, and therefore can defend against the incidence of pneumothorax more easily (and of course the chest surgeon charges more).
So now the doctor's mantra is not to avoid error, but to avoid being sued. This is not synonomous with practicing the best medicine. I even know some doctors who refuse to treat any lawyers or their families at all, just as many landlords in NYC refuse to rent to lawyers.
Again, every doctor wants to take the best possible care of his patient, but if 1/2500 infants is born with a birth defect, and 5% of aortic aneurysm repair patients die, and if 1% of hip replacements get infected, the doctor seems to get sued for every bad result. Although in theory the plaintiff has to show the doctor did something wrong, in practice the doctor has to show that he did everything right, and if he/she did, why was there a bad result? In American jurisprudience, if anyone has a bad result in anything, it is someone's fault (unless, of course you lose a lawsuit, and then it is never the lawyer's fault).
One final note: In NY State, they started keeping a record of the death rate for open heart surgeons (and later, their hospitals). The immediate result, as you might expect, is that cardiac surgeons took on fewer riskier cases where the patient has an estimated less than 10% chance of survival, no matter how the family pleads, because he doesn't want his death rate to go up. Several years ago there was a piteous Op-Ed piece about this in the NY Times, by a columnist who said it took him 10 days to find a cardiac surgeon willing to risk operating on his mother, and the surgery was not done at a major hospital teaching center.
I guess I should close with a repeat of a previous story. About 10 years ago, a California woman refused a pap smear for several years in a row, and her refusal was well-documented in the chart. When she died from cervical cancer, the husband sued the gynecologist. He convinced the jury that if the doctor had warned the patient properly, then any prudent patient would have agreed to the pap smear and found the cervical cancer. The jury agreed (!), and found against the GYN who now, of course, fires from his practice any woman who refuses an annual pap test or mammogram.
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