Presidential Politics and Influenza Vaccinations

Recently a patient of mine expressed frustration with the presidential campaign, saying the other side wouldn’t listen to facts and just believed what they wanted to believe.

Knowing that she had repeatedly refused to get a flu shot, I asked her in that case if she’d like to get one, given that scientific studies have shown that the benefit outweighs the risk for most people. Although she hesitated, I unfortunately could not convince her.

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 Payment Formula Finally Changed – Win or Loss?

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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.

Up in Arms, Up in Smoke

20090715_japan_0671If 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.

 

Prostate Cancer – A Fish Tale

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Have you heard that fish oil supplements cause prostate cancer? The news items come from an article published online July 11, 2013 by Brasky et al. in the Journal of the the National Cancer Institute, “Plasma Phospholipid Fatty Acids and Prostate Cancer Risk in the SELECT Trial.

This study looked at 834 men diagnosed with prostate cancer, and compared them with 1393 men, matched for age and race, that did not have prostate cancer. They then looked at the amount of omega-3 in their blood and compared the groups.

They found that those with the highest omega-3 levels had the highest risk of prostate cancer, 44% higher over all. This study followed up on one published earlier by the same group that suggested increased risk from fish consumption. The levels of omega-3 in the highest group were fairly modest, equivalent to eating an oily fish, such as salmon, twice a week.

Before jumping to the conclusion that men should not take fish oil or consume much fish, there are a number of things to consider. First of all, association does not imply causation. What does that mean? Just because two things occur together, it does not mean that one caused the other. If you look outside on a rainy day, you will see many people carrying umbrellas. But you would be wrong to conclude that carrying umbrellas caused it to rain.

It could be that it wasn’t the omega-3 in fish, or fish oil supplements, that caused prostate cancer, but rather something else in the products, such as mercury or other toxins in the fish. If you ate fish raised in places low in pollution, or consumed ultra-filtered fish oil, then perhaps it would not be a problem. This study does not answer that question.

Even if eating fish or taking supplements increases the risk of prostate cancer, studies have shown it decreases the risk of cardiovascular (heart) disease, which is far more common.

This study was not the preferred double-blind, placebo controlled study, and the conclusion may just be wrong. After all, other studies have shown that fish consumption decreases prostate cancer. For example, one in the Lancet showed decreased risk of prostate cancer in those who ate moderate or high amounts of fish. Also consider that Japanese men consume much more fish then American men, yet have far less prostate cancer.

So until I see more convincing evidence, I’ll continue to take my fish oil capsules, and enjoy eating salmon.

An Epidemic of Gun Violence

Last week I wrote about the 1st Amendment. This week I’m going to talk about the 2nd. There is an epidemic of gun violence. This is a serious health problem. Watching your diet, exercising, and taking pills is all for naught if a bullet kills you.

In Newtown, Connecticut, one of the worst mass shooting occurred last week when a gunman shot his mother at home, apparently with her own gun, then walked into an elementary school and shot 6 other adults and 20 children, before shooting himself. Gun rights are hotly debated and highly politicized, but gun violence is a serious health issue. The National Rifle Association (NRA) and others have been strong proponents of gun rights, and have fought hard to fight off attempts for even the slightest form of control, including restrictions on semi-automatic and assault weapons.

One of their arguments is that citizens can protect themselves with guns, and that concealed guns are a particularly effective deterrent because potential assailants won’t know who may be armed. But in 61 cased in the US in the past 30 years, maybe only one was stopped by a gun other than their own, or by the police. Even if people want guns to protect themselves, they shouldn’t need to cover the contingency of an invading army, so I see no need for high capacity bullet magazines.

Many mass shooters have mental illness and we need to do a better job providing access to mental health treatments. Some illnesses, such as schizophrenia, often don’t really manifest until people are in their teens or early 20’s, allowing them to purchase guns when their sick enough to do real damage, but not so severe that they would have more trouble planning an attack or convincing someone to sell them a gun. Even if not mentally ill, young men tend to act less rashly as they get older, and are more likely to consider the consequences of their actions. From a list of 22 of the deadliest mass shootings around the world, 65% of them were under 30. We already have a law that says that people can’t buy alcohol until they are 21-years-old, even though they can vote and serve in the military at 18-years-old. Perhaps the right to own a gun should only be allowed for those who are at least 30-years-old.

We need to close legal loopholes, such as sales between private buyers, that allow people to avoid background checks before purchasing guns. I need to fill out more paperwork to prescribe shoes for a diabetic than to buy an assault weapon. We need people to speak up and let our politicians know that gun violence caused by guns is not acceptable. We’ll never prevent all such tragedies, but we should try to minimize the possibility as best we can.

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.

Aspirin – Coated or Naked – Does it Matter?

Aspirin is often used to prevent heart attacks and strokes. Patients usually take an 81 mg (baby aspirin) or 325 mg (regular strength) pill. It also comes in plain, enteric coated, or buffered. Enteric coated aspirin is often recommended to decrease the risk of ulcers, the idea being that it doesn’t dissolve until it gets past the stomach, though there is limited evidence that it really makes a difference.

Another concern over the past decade is that some patients may be resistant to aspirin, and perhaps needed to be on more expensive medications, such as Plavix (clopidogrel), which recently went generic, though is still pricier than aspirin.

Now a new study from the University of Pennsylvania, published in the magazine Circulation, questioned the idea of aspirin resistance, and said that some patients who did not respond to the coated aspirin did respond to plain aspirin. But that does not mean you should conclude that taking coated aspirin may put you at increased risk for a heart attack.

This study looked at 400 health volunteers and gave them a single 325 mg dose of aspirin, either plain or coated, and measured the chemical cyclooxygenase-1 to see if it worked. If they appeared “resistant” then they gave one week each of coated 81 mg aspirin and clopidogrel. Although 49% of the volunteers did not respond to the single aspirin, they all responded to the daily dosing.

So the bottom line is if you take a coated aspirin every day, you probably don’t need to be concerned about it not working. If you don’t regularly take aspirin, but experience chest pain, after you call 911, take a plain aspirin, and preferably chew it to speed absorption. If you only have coated aspirin, it should work just as well if you chew it. Coated aspirin, made by Bayer and other manufacturers, are a little more expensive than plain aspirin, but are still fairly inexpensive.

Tort Reform and the Sanctity of the Jury

I serve on WAMPAC, a political action committee for the Washington State Medical Association (WSMA). To help guide our members, last month we met with candidates for Washington State governor Rob McKenna and Jay Inslee.  They were both generous with their time and answered our questions.

As physicians, one of our issues is tort reform. We are concerned that large and unreasonable malpractice awards increase the cost of medical care and cause physicians to order unnecessary tests as ‘defensive medicine’. Attorney General Rob McKenna said he was supportive of tort reform, though didn’t give much specifics. Congressman Jay Inslee said he did not believe in malpractice caps because, he said, unlike others, juries are untainted and therefore we need to respect their decisions. That prompted me to send him the following letter. One month later, he has yet to respond. I wonder how I’ll vote in the primary?

Dear Mr. Inslee,

I enjoyed meeting you, and appreciate your spending time to talk with the Washington State Medical Association WAMPAC Committee 7/3/12 regarding your candidacy for governor.

On the issue of tort reform, you mentioned that you didn’t support malpractice caps because you believed in juries making the decision, as they are untainted by lobbyists or others.

Speaking for myself, I have some concerns about this. Short of Plato’s philosopher kings, juries may be the best choice to decide cases, but they are hardly perfect. There are numerous well documented cases of people sentenced to death, yet later found innocent by DNA evidence. In malpractice cases, I would argue that juries are far from perfect. How else could you explain the differences in the chances of being sued and the size of the award based on specialty (http://www.nejm.org/doi/full/10.1056/NEJMsa1012370)? The average neurosurgeon is sued once every 5 ½ years. You would be hard pressed to find a retired neurosurgeon who has never been sued.

Even if juries make perfectly logical decisions, it’s only as good as the cases presented to them, which may be flawed.

In cases where juries decide the outcome, there are restraints. There are judicial guidelines, and juries cannot impose the death penalty for shoplifting, for example, even if they wanted to. Putting financial caps on malpractice cases would be no different. The jury could still decide if the defendant is guilty, but guidelines would cap the size of the reward.

I hope you will reconsider your view on tort reform.

Sincerely,

Daniel Ginsberg, MD, FACP

Right for the Wrong Reason?

In 2007, Texas Governor Rick Perry signed an executive order mandating that teenage girls be vaccinated with Gardasil, a vaccine that helps prevent cervical cancer by providing protection against Human Pappillomavirus, or HPV. This was subsequently overturned by the Texas legislature. Now it’s a matter of discussion among Republican presidential candidates. Representative Michelle Bachmann has criticized not only that, ““To have innocent little 12-year-old girls be forced to have a government injection …is just flat out wrong,” but has also suggested that he was motivated by political donations from pharmaceutical company Merck.

We’ll have to see how things play out in regards to whether Governor Perry made his initial decision because of political donations, but it least has the appearance of impropriety.

From a medical point of view, I think he was right to mandate vaccination against HPV, even if he did so for the wrong reason. According to the CDC and the American Cancer Society, at least half of sexually active people will get infected with HPV in their life. Half of those people are infected between 15 and 24 year of age.

In the United States, about 12,000 women are diagnosed with cervical cancer, and 4,000 die from it, each year. HPV causes most of these, as well as many cases of anal and oropharyngeal (mouth and throat) cancer, and genital warts.

As a father of daughters, I get that when they’re 10 to 12-years-old, you don’t want to think of them being sexually active. But most people eventually are, and you can’t be certain that it will only be with one uninfected person the rest of their life. Once they’re infected, it’s too late.

The policy for vaccination against HPV should not be different than for other infectious disease, such as tetanus, polio, measles and chicken pox. If you love your children, you should seriously consider vaccinating them. Even if he had ulterior motives, I think Governor Perry had the right idea.