In 2011 the North Carolina legislature made major changes to the law governing medical malpractice claims. This tort reform, among other things, capped non-economic damages at $500,000.
Such caps on damages do not restrict payments for financial losses, such as future income not earned due to no longer being able to work as a result of injury or death because of something a doctor did, or neglected to do. Rather it limits awards to compensate for such things as pain and suffering.
Physicians in Washington State, and elsewhere, have lobbied for tort reform. Although some physicians have been guilty of gross negligence, in many cases doctors are sued, and juries award large amounts of money, because a patient has suffered, but not necessarily because of something the physician did wrong. Because physicians worry about getting sued, they tend to practice defensive medicine, and order more tests and procedures than necessary as a result. Besides wasting money, it can cause harm. I’ve had patients who have had dozen of CT scans, because every time they go to the emergency room for abdominal pain, they get one to make sure they don’t have such things as appendicitis. The radiation from the CT scan increases the risk of developing cancer in the future. Although such scans are certainly warranted at times, I believe they are excessively ordered because of fear of getting sued.
Between 1929 and 1974, North Carolina forcibly sterilized 7600 people it deemed socially or mentally unfit. Recently the state agreed to set up a $10 million dollar fund to compensate living victims. So far they’ve identified 177, though as of 2010 the State Center for Health Statistics estimated that 2,944 victims may have still been alive. If they end up with 200 such people filing claims, they would each get $50,000. That’s only one tenth of the amount allowed in that state for non-economic damages, and one hundredth if 2000 filed claims, and infinitesimally less in a state that has no such cap. Physicians may be well off, but their pockets are not nearly as deep as a state.
If a physician inadvertently sterilized a patient while treating them for something else, they could be sued for large sums of money for depriving them the chance of procreating. If states can cap non-economic damages for doing the same, isn’t it only fair that limits be placed on non-economic damage for malpractice for physicians who were trying to do the right thing? Although that’s true in about 30 states, the Washington State Supreme Court ruled such caps unconstitutional in Sofie v. Fiberboard Corp., 112 Wn.2d 636 (1989). Although that was not a medical malpractice case, the reasoning goes against the decisions made by a majority of other states, and ignores the fact that resources are limited. No caps in theory means a jury could bankrupt an individual or company, no matter how large, and no matter how many hurt if that happened, all in the name of “justice” to benefit one person, and their legal team of course.
The Chinese are less concerned about safety than American. We worry about health risks, perhaps obsessively at times, but from my perspective it’s less of a concern to them. As I wrote, I thoroughly enjoyed a recent trip to China, but now want to discuss some observations on medical issues in China.
Smokers at tables flanking a no smoking sign in a Beijing restaurant.
They smoke much more, and allow smoking in many more places. No smoking signs are often ignored.
In some of their cities, they breath in much more pollution. The Chinese government publicly posts measurements of the air quality, but it’s often significantly less than the United States Embassy measurements. Here are readings I recorded during our trip.
China Air Quality Shanghai – Official ReadingChina Air Quality Shanghai – US Consulate
This score of particulate matter was created by the Environmental Protection Agency and goes up to 500, which was supposed to be the scale maximum. Recently readings in Beijing have been as high as 755. According to China’s Ministry of Environmental Protection, less than 6% of vehicles in the country meet the highest environmental standards, and there is particularly a problem with the tiny particles known as PM2.5, thought to be particularly toxic. Most of this is generated by older cars and trucks.
Bicycle and motor scooter riders don’t wear helmets. In 3 days of driving around Beijing our guide never wore seat belts, even on the highway. The driver only wore it one time briefly. Eighty percent of car sales are to first time buyers, and many of them have little experience. Pedestrians do not have the right of way. One evening we drove past a man crumpled up on the street, with a man standing next to him talking on the phone, and no ambulance in sight. I can’t be certain, but I believe he was hit by a car trying to cross the street. Shortly after leaving our hotel in Shanghai on the way to the airport, our bus was temporarily stopped in traffic after a motorcyclist was hit and was laying on the ground. If we saw two people hit in 8 days, imagine how often it must occur.
They seem to be less germaphobic than most Americans. Their tap water is not potable unless you’ve lived there long enough to have developed resistance. They eat family style sharing multiple dishes, but do not give serving utensils, so everyone dips their own chopsticks into the common food.
According to an article in the 11/14/12 China Daily newspaper, obesity is becoming more common in Shanghai. It said that roughly 40 percent of adults in Shanghai are obese or overweight. A survey released at the end of 2011 showed the average weight of male residents had increased by 2.9 kg (6.4 lbs), and weight circumference had increase 2.3 cm (0.9″) since 2000. Certainly they have much less obesity than we do in the United States, but it’s likely to get worse. They are less physically active, with motor bikes more common than bicycles, and their diet is getting more westernized. I saw many McDonalds, Haggen-Daz, and Starbucks in Beijing and Shanghai.
Another article in the same issue said the number of people in mainland China with diabetes has doubled in the past decade to about 9.7% in those 20-years-old and older, and that only 40% of them have been diagnosed. Because of the increase in chronic illnesses there, pharmaceutical company Eli Lilly & Company plans to expand in China to increase sales of their drugs for diabetes, the heart and cancer.
We went to the China Academy of Chinese Medical Sciences at the Science and Technology Center (www.china-tcm.com). While our feet soaked in a tub of tea, someone came and talked about the center. It was started in 1955 under the direction of Mao Tse Tung. It mostly serves the government leaders. He said none of them have heart problems, cancer or high blood pressure. He said only Chou Enlai had liver cancer in 1976 when they were less developed. Next students massaged our feet while a doctor examined me, then my wife, while a woman translated. He felt the pulse with 3 fingers check on each side. He said I had problems with blood pressure and fatty liver and said I should lose 5-6 kg. I’ve not had problems with the first two, but wouldn’t argue with the last. He also asked if I had an eye problem. I actually have had some problems with eye inflammation, but perhaps he looked in my eyes and noticed the affect of a combination of air pollution and jet lag. He recommended 2 medicine, each ¥650 (about $100) for a month supply and said I needed to take it for only 1-2 months. He said I would be amazed at the difference. When I hesitated he asked if my patients take their medicine when I prescribe it. I ended up buying a one month supply for myself as I felt a little guilty they had spent all the time on us, and it was place that didn’t seem to get many foreigners. I figured if for nothing else, it would make a good blog post. In my n-of-1, non-blinded, non-placebo controlled study, I found no difference after taking the medications for one month. Well actually I did lose about 3 lbs, but I suspect that was from following my New Year’s resolution with more exercise and an even better diet. Considering that I felt the same, despite being a month older, maybe it did do something.
Although I joke about it, I suspect some herbal medicines are effective. After all, some pharmaceutical medications in use today are derived from plants. Before taking such medications long term, one should be concerned about not only effectiveness, but safety, including the risk of contamination with lead and other chemicals.
I was going to try acupuncture, but our guide couldn’t find a place she felt comfortable recommending (sterile needles, etc.).
Prior to the trip I obtained a hepatitis A vaccination. That’s the one viral hepatitis that can be transmitted by contaminated food, which although it doesn’t caused a chronic infection, can definitely put a damper on your vacation.
China seems to be moving in the right direction in some areas related to health and the environment, which I hope they sustain. They don’t need to adopt all the practices of Western society, nor would I wish them to do so, but the Chinese people shouldn’t needlessly suffer from from such things as traffic fatalities, pollution, and smoking, and those things should minimized as much as possible.
The Food and Drug Administration (FDA) has ruled that pharmaceutical companies cannot promote drugs for purposes other than the reasons for which the drug was approved. Physicians are free to do such off-label prescribing, however the drug companies cannot suggest in any way that physicians and other prescribers do so.
Companies have to do expensive studies to show that a medication is both safe and effective. How the FDA approves the drug is based on the research the company did. For example, Neurontin (gabapentin) is approved for certain kinds of seizures, post-herpetic neuralgia, and neuropathic pain. In 2004 Warner-Lambert paid $430 million in a court case brought by the government for off label use. The pharmaceutical company sales representatives had, promoted it for conditions including bipolar mental disorder, Amyotrophic Lateral Sclerosis, attention deficit disorder, migraine, and other conditions.
Some of those claims were true, and the company later received the nerve pain indications that it didn’t originally have. Physicians may rightly prescribe the medication without it having an indication because they have reasons to believe it may work based on the pharmacology or published studies. The pharmaceutical company may just not have been able to get it approved yet, or if it’s not a common problem, they may decide that financially it’s not worth the cost of getting an indication.
When a physician prescribes a medication, there is usually no direct economic benefit to them, and whether they are right or wrong, they will prescribe a medicine because they think it will benefit the patient. That’s not necessarily true of pharmaceutical companies, though. They have a direct economic incentive to sell as much of their product as possible, and their sales reps are often compensated on how many prescriptions the doctors they call on write. So although many of the reps are ethical, economic pressures are a strong incentive to get them to push for off label uses. Multi-million dollar settlements help hold those pressures in check.
Recently a three-judge panel of the Second Circuit Court of Appeals, in a case involving pharmaceutical sales rep Alfred Caronia, ruled that the FDA regulations violated the First Amendment’s guarantee of free speech. In an editorial the Wall Street Journal sided with the court, saying that, “health regulation is by nature health coercion.”
The Wall Street may smack down anything at all related to the Affordable Care Act (ObamaCare), but I think they are wrong. I’m not a lawyer, and much less a constitutional one, but I think of free speech in a different way. I don’t think selling a product is free speech. Selling an idea is. If you are not allowed to put up a sign touting you believe or don’t believe in God, for example, then your right to express your opinion is being abridged. If, however, you put up a sign saying the price of gasoline at your station, that’s not stating what you believe in, that’s just advertising. Granted, some cases might be fuzzy and I would err on the side of free speech, but sales reps talking about their medications are usually just advertizing. In fact the FDA does allow companies to support off label use, but it’s strictly limited (done by a physician in response to questions, etc.).
The Supreme Court acted in a similar manner in 2010 when they removed some limitations to political causes, allowing unlimited donations. This led to over a billion dollars donated in the last presidential cycle. It was done in the name of free speech, but because they could blanket the airwaves with ads, I’d argue those with less money basically lost some of their free speech to rich donors.
A lot of taxpayer money is spent on prescription medications. Busy physicians don’t have time to fact check every thing pharmaceutical sales reps tell them. Allowing reps to say whatever they want, in the name of free speech, is not good for anyone’s health, other than perhaps that of the pharmaceutical companies.
Though implementation has been delayed until 2013, per the Sunshine Law, pharmaceutical companies are now collecting information to report to a public website the value of things they give to physicians, including such things as dinner meetings. It may sound like doctors are just being wined and dined to get them to prescribe their medications, but as I’ve said before, there is value in such dinners.
For example, I went to a local dinner meeting early this year, featuring a speaker who was an expert on hypertension. Sure the meal was free, but not such a bargain when you considered that my wife could not attend, it was with people I might not necessarily have chosen to dine with, and despite a long day at the office, this expert was talking about medicine before I could even look at the menu.
But it was worth it because I learned some valuable information. As a result of hearing him talk, one change I made was to more often start giving at least one blood pressure medication at night because he said it would help prevent early morning strokes and heart attacks. After that meeting I later saw an article confirming the value. Had I not attended the talk I might have eventually changed my prescribing habits, but I changed it sooner as a result. In fact studies have shown it usually takes ten years for doctors to incorporate new medical information into their practice.
The pharmaceutical company that sponsored that dinner has a blood pressure medicine that I use some, but frankly not that much, and it has not increased since that dinner meeting. But perhaps I saved a life as a result of knowledge gained from that meeting.
When I was an internal medicine resident, one of my staff attending’s, Dr. Charles Reasner, used to ask, “What is the indication for ordering a TSH?” This is a test of thyroid function (thyroid stimulating hormone), and he was asking what reasons should one order the test. His answer was to order it if you think about it. An overactive (hyperthyroidism) or under-active (hypothyroidism) thyroid can cause many different kinds of symptoms, treatment is relatively easy, and the test is inexpensive. Thus he said if it occurred to you to order the test, then you should do so.
Unfortunately the Centers for Medicare & Medicaid Services (CMS)does not allow us to order tests based on intuition, even though numerous studies have shown that people often make their best decisions based on reasons they can’t explain. When a quarterback such as Peyton Manning throws a football to a receiver, he first has to make the decision what to do very quickly, while a 300 pound lineman is bearing down on him. Based on prior experience he can quickly survey the field and make a decision where to throw the ball before he could make a decision based on a logical analysis. He might not be able to explain exactly why he did something, but his skill and training contributed to making the right decision seemingly without thinking.
When physicians order a test, we have to associate a diagnosis. Presumably the main purpose is to prevent wasting money for ordering tests. Although there is no benefit in ordering a PSA test for a diagnosis of glaucoma, for example, this only catches errors in the test ordered or diagnoses associated, which probably doesn’t happen often. It’s a real problem though for ordering a vitamin D level.
Medicare no longer covers a screening test for vitamin D, even though perhaps 85% of patients in the United States are deficient, treatment is cheap, and it probably saves money in the long run. Once a patient is diagnosed with osteoporosis then a level is covered, but that’s too late. Plus in men a screening bone density test is not covered, so it’s a Catch-22 situation.
At least if not that expensive, physicians should be able to order labs because they think of them. Insurance companies and the government should trust our intuition.
Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.
Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.
I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.
So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.
Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.
Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.
Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.
A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.
The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.
I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.
The Health Information Portability Act (HIPAA) has criteria about not violating patient privacy, and potential harsh penalties for doing so. One needs to not only avoid saying a patient’s name to the public (meaning people not involved in the patient’s care), but not even to provide enough identifying information to allow someone to identify a patient. If you say you saw a 45-year-old male architect for diabetes, and there aren’t that many architects in town, you’ve probably supplied enough information for someone to figure out who you’re talking about.
I’m usually pretty conscious of it, and some of my colleagues are used to me ‘coughing’ “HIPAA” when they say a patient’s name aloud. One day, however, while eating lunch with my colleagues, I told the story of an 80+ man who came in complaining of a large bruise on his leg that he sustained after a fall when he tripped while running backwards. One of my colleagues said, “Was that Bob Smith*?”
“How did you know?” I asked.
“We go on the ski bus together and after he gets off he always runs backwards around the bus!”
*Not his real name, and yes, I got his permission to post this story.
This week the Supreme Court agreed to hear a legal challenge to the healthcare reform law, colloquially known as ‘Obamacare”. They have scheduled 5 1/2 hours for oral arguments, dividing the law into four parts, that they will hold over two days. According to a number of articles, this is pretty much unprecedented in modern history. Since 1970 the typical case is allotted one hour for oral arguments, with 30 minutes for each side.
I’m not a lawyer, but I was astounded by these numbers. I realize that the Supreme Court justices spend a lot of time reading written briefs, and probably have internal discussions, but only spending an hour listening to arguments for an issue that has hit the highest court of the nation does not sound like much time to me. If I have a complicated patient in my office, it’s not so unusual that I end up spending an hour on them, and unless they are going on Hospice, they always get a follow-up visit. The Supreme Court gets about 10,000 petitions a year, and only rules on a small fraction of them. Before it gets to that level, many lawyers and judges have already debated the issues, and if the answer was obvious, it would probably have been settled. It seems stingy to me to only giving one hour for oral arguments for cases at that level.
Even 5 1/2 hours doesn’t sound like much. The 12 members of the debt reduction super committee couldn’t come to an agreement on debt reduction after working on the issue for more than 3 months. That’s far more time than the Supreme Court will spend working on the health care law, and I’m not sure that it’s that much less complex than dealing with debt reduction. Of course the justices have the great advantage of not having to worry about getting re-elected.
Washington State Medicaid has new requirements for ordering imaging tests. I ordered a dobutamine Cardiolite stress test for one of my patients. The coder in my office brought me the Cardiac Imaging Questionnaire – CarePlanner/iEX form. It had 41 questions which she gave to me because she can’t tell from the chart how to fill it out! As it turned out I didn’t have to answer all the questions, but it still took a while to figure out what questions I needed to answer and look up the information in the chart.
Physicians usually lose money when seeing patients on Medicaid since the reimbursement is less than the cost. Add in ridiculous paperwork burdens, and they may find that primary care doctors start referring their patients to specialists rather than do the test themselves. Then the Washington State Department of Social and Health Services (DSHS) can pay for the cardiology consult instead, to be followed by the test I wanted to do in the first place, or a more costly cardiac catheterization. If I think a patient needs a test, it’s pretty rare when the specialist does not agree that the patient needs that, or a more expensive test, done. Making it more cumbersome for primary care physicians will likely ultimately raise costs, not decrease them.
A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.
The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.
The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.
The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge ActS.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.
The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.
Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.
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