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Going Viral is Bad for Your Health

A few days ago CNN hosted the 2nd Republican presidential debate. Unfortunately, the topic of vaccines came up. Donald Trump had previously suggested that vaccines can cause autism. When asked about this he responded, “You take this little beautiful baby, and you pump — I mean, it looks just like it is meant for a horse, not for a child, and we had so many instances, people that work for me, just the other day, 2-years-old, beautiful child went to have the vaccine and came back and a week later got a tremendous fever, got very, very sick, now is autistic.”

He went on to say that he’s not against vaccines, but just thinks the same total dose should be given in smaller doses and spaced out more.

Donald Trump is not a doctor, so why is he giving medical advice? Republican presidential hopeful Dr. Ben Carson, a retired pediatric neurosurgeon, said, “We have extremely well-documented proof that there’s no autism association with vaccinations. But it is true that we are probably giving way too many in too short a period of time.” Although he at least discredited the theory that vaccines cause autism, he agreed with an alternative dosing schedule. Fellow debater Senator Rand Paul, who is also an ophthalmologist, said, “I’m all for vaccines, but I’m also for freedom. I’m also concerned with how they’re bunched up.”

The American Academy of Pediatrics put out a statement saying there is no alternative dosing regimen. Based on lots of scientific literature and much expert opinion, the current schedule was designed to optimize benefit versus risk. Delaying vaccinations increases the risk that children will catch the disease before they have been protected. It’s also psychologically more traumatic. Studies have shown that a child is just as traumatized if they get one shot or three shots at one visit, but 3 visits with a shot at each one is worse than one visit where they get 3 shots. Spacing out the vaccines also means more cost, and more exposure to sick kids each time they are brought for a vaccination.

So where did this idea of spacing out vaccines come from? Pediatrician Dr. Sears published “The Vaccine Book” in 2007 that proposed alternative vaccination schedules. But that was just his opinion, and was not based on studies to show that it’s safe and effective.

The belief that vaccines can cause autism came from a study published in 1998, that has since been retracted because it was found to be based on fraudulent data. Some people still choose to believe it.

You might argue that spacing out the vaccines is better than nothing. That’s true, however that’s like saying that only wearing seat belts every other day is better than nothing. That’s true, but it’s still much better to use it the way you’re supposed to.

Republicans don’t have good record when it comes to vaccines. Four years ago Rep. Michele Bachmann (R-Minn.) attacked Texas Governor Rick Perry for mandating that young women get HPV (human papilloma virus) vaccine. He later backed down. That vaccine prevents women from getting cervical cancer.

I may not agree with politicians when it comes to issues regarding such things as immigration, taxation, use of the military, domestic spying, or abortion, but those are legitimate areas for politicians to debate and legislate. They can even debate the wisdom of the Affordable Care Act (ObamaCare), but they should stay out of the science of medicine. That includes politicians who happen to be physicians, unless they are stating medical facts, rather than pandering to what their constituents want to hear.

Medicare Audits – Or How I Spent Part of Labor Day Weekend

Some weekends I go to my office to try and catch up on paperwork. This Labor Day weekend I had to ‘labor’ away part of it to satisfy a Medicare requirement.

I received a fax from a medical supplier saying that Medicare had sent them an, “additional documentation request” for diabetic supplies for a patient of mine from June 2013. I didn’t see her on the date of service they listed, nor even see that I prescribed any diabetic testing supplies then, though it’s possible I filed out a faxed form and it wasn’t saved to her chart.

They requested that I include copies of the patient’s blood glucose testing logs. I do not routinely scan those into the chart, so I don’t know how that’s supposed to happen.

They also say to verify that the records contain the following other items, though it could be considered fraud to go back and add them now:

Patient’s Diagnosis and Prognosis
Patient’s Testing Frequency
Condition and Treatment History
Quantity and Day Supply Prescribed
Physical Limitations Due to Condition
A1c Lab Report
Insulin/Non-insulin
Insulin Injections/Pump
Medication lists

In addition, they want all documentation from 6 months before the service date up to the present day, and they want it, “ASAP.” That’s 2 years and 9 months of documentation, all for a few diabetic test strips I prescribed (which I don’t make any money from, for the record)!

What’s more, it says that we are not allowed to charge the supplier or the beneficiary (the patient) for providing this information.

That’s your government, hard at putting us primary care doctors to work.

Asinine Associations

As I previously wrote, when physicians place orders, they have to associate diagnoses. This is becoming even more painful as we move towards ICD-10, of which I’ll have more to say later.

I’m sure this was an attempt by the government to save money, but in the vast majority of cases the ordering physician has no secondary gain, and they order the test because they think it’s the right thing to do. I can understand it for some expensive tests or procedures, but many are just plain obvious.

I think lawmakers should have a taste of their own medicine. When they need office supplies, they should have to give a reason. Here, I’ll help them out with a few items to help them understand how it works:

Staples – To attach separate pieces of paper.

Notepad – To write down information.

Pen – To apply in conjunction with a notepad to convey information.

Chair – To help counteract gravity to prevent leg and back pain and fatigue.

Laser Printer Toner – To print out things using a laser printer.

Light Bulb – To counteract darkness.

Medicare Payment Formula Finally Changed – Win or Loss?

Congress passed a law in 1977 linking Medicare payments for physician services to growth in the economy. Because it failed to take into account inflation and other factors, Congress has had to act 17 times to prevents cuts to physician pay under the sustainable growth rate (SGR) formula. This year physicians were set to get a 21% pay cut this year. This created a lot of stress and uncertainty for physicians, and caused some physicians to stop accepting Medicare patients.

The Senate recently voted to repeal this formula, 92 to 8. The bill was already approved by the House, and now President Obama has signed the bill.

That sounds like a great triumph for physicians. Although this may prompt some to pull out their imaginary violins in mock sympathy, I’m not so sure it will turn out to be such a great deal for physicians, which actually only consumes 12% of the Medicare budget.

The bill freezes the current rates, then increases them 0.5% a year from 2016 to 2019. For 2020 through 2025 there is no increase, and from 2026 onwards it increases by 0.75% per year. That is far below the current rate of inflation, and there is no provision if inflation gets worse than the currently low rate. That effectively means a real loss every year into the indefinite future.

There is a provision to transition payments to reward physicians for quality, rather than quantity. That is good in theory, but we’ll have to see how that works out in practice. Quality healthcare is very difficult to measure, and there is a risk that quality will be defined based on what’s easy to measure, and that will lead to physicians and other healthcare providers to concentrate on what they are rewarded to do, and not what may be in patients’ best interest. I hope I’m wrong.

FMLA Paperwork

I’m often asked to fill out FMLA paperwork, formally known as Certification of Health Care Provider for Employee’s Serious Health Condition (Family and Medical Leave Act). This is either because my patient is ill and they or a family member need to take time off work, or because my patient needs to take time off to care for a family member. Employers want the form as proof that the time taken off is legitimate, even though it is not paid time off.

The four page form is onerous to fill out. If you read the fine print you can see that the Department of Labor estimated it would take 20 minutes to fill out. That’s more time than I get to see a complex medical patient, and at most we charge $25, and often don’t get paid at all. It may be a service to patients, but most of the information requested is not needed, and is not the employer’s business. This task usually falls to primary care physicians. If it’s something we need to do, it should be as simple as possible and not waste our time filling out irrelevant information.

Below is a letter I sent as a suggestion to simplify the form to a single page (formatting of the form altered a little for web display). It has been over two years without a response. Continue reading “FMLA Paperwork”

Quitting Smoking and Happiness

The FDA is proposing a new rule in regards to tobacco regulation. As detailed recently in the New York Times, the benefits of stopping smoking, such as less heart and lung disease, would need to be discounted 70%, making it that much harder to justify spending money on smoking cessation. It sounds like something inserted at the bequest of tobacco lobbyists. Tomorrow is the deadline to make a public comment. Here is what I submitted:

I think it’s a dire mistake to discount the economic and health benefits of stopping smoking because of the loss of enjoyment. Although smokers may get temporary enjoyment from smoking, they also get enjoyment from being healthy. Surely one gets more pleasure taking a walk in a park and living at home, than pushing an oxygen tank down a hall in a nursing home because of severe emphysema. Smokers die at a younger age than they otherwise would. What about the enjoyment their partners, children, and grandchildren lose when the smoker dies prematurely? Loss of enjoyment should not be part of the equation, unless it’s a negative number which would serve to magnify the cost smoking places on individuals and society.

Up in Arms, Up in Smoke

If you apply for health insurance, you may find you have to pay higher rates if you’re a smoker. Now federal regulators are trying to decide if insurers who participate in the Affordable Care Act (aka ObamaCare) exchanges can add a surcharge for those using e-cigarettes or vaporizers. They already can for cigarettes in most states.

Some argue against this, in the name of harm reduction, the idea that if people are going to smoke, it’s better to smoke something safer. For example, Reynolds American Inc spokesman David Howard, said, “We don’t believe policies should be implemented that might deter current smokers from considering switching to smoke-free alternative products like e-cigarettes.”

Numerous studies have, shown, however,that the best way to get people to cut back on smoking, is to make it more expensive. E-cigarettes and vaporizers are cheaper than cigarettes, so paying more for insurance for all forms will encourage more people to stop smoking. No one is suggesting that those smoking alternative forms of tobacco be charged more than those who smoke cigarettes, so even if insurers charge extra for those who use e-cigarettes or vaporizers, they will not pay more than if they stuck with cigarettes, so really it won’t deter smokers from switching. People switch because it costs less, it’s more socially acceptable, or they perceive it to be safer.

In that last regard, vapor may be safer than cigarettes, but we really don’t know. Recent studies show they can definitely have known carcinogens, such as formaldehyde. Would you really want to inhale a chemical used to embalm corpses? I tell my patients that if they use e-cigarettes to help them quit smoking, which may or may not help, then I’m alright with that, but the goal should be to stop using tobacco products, and not just switch from one habit to another.

Tort Reform and Forced Sterilization in North Carolina

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.

Health in China

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 Reading — China Air Quality Shanghai – Official Reading

China Air Quality Shanghai - US Consulate — China 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.

Off Label Drugs and Free Speech

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.

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