What Are We Selling in Public Health?

There isn’t a week that goes by where someone doesn’t call me a “Pharma Shill.” They claim that I must be getting paid by “Big Pharma” because I dare say that vaccines say lives and counter the claims of antivaxxers on social media. (“Claims” is a gentler way of saying “outright lies.”) As of the writing of this blog post, I have not received any money from any pharmaceutical company for any of my vaccine policy advocacy. Heck, I don’t even invest in any pharmaceutical company, though I’d like to. I would make a killing choosing the companies that are aggressively pursuing treatments and therapies for the biggest or most urgent public health problems.

I also noticed that a lot of classes at the School of Public Health were somewhat business oriented, or they shared characteristics similar to classes one would take while working toward a business degree. For example, I took a management course where I learned about motivating people. They even taught us how to fire an employee or reassign staff who aren’t being productive. And they taught us about customer service. Certainly, a lot of what goes into a successful presentation in public health is borrowed from a successful presentation on how to sell something.

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And don’t get me started on how many times I’ve been told to prepare an “elevator pitch” about my ideas, my projects or my dissertation. Elevator pitches are those very quick (the time it takes to ride an elevator) summaries of what you’re doing and what you’d want your audience (hopefully one Warren Buffett on his way to the penthouse) to do for you with the information you’ve provided.

So what are we selling in public health?

Are we selling ideas? It certainly seems like most of the time we are trying to convince people to do something that is beneficial to public health or to not do something that is detrimental to public health. To convince people about this, you have to implant an idea in their minds that the behavior (which is also seeded in their minds) needs to change. This is easier said than done, right? And, admittedly, some ideas are better than others.

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The best idea.

Are we selling a product? We kind of are because we want you, the public, to use vaccines, seat belts, helmets, and, if you’re in the healthcare business, we want you to use gloves, masks, aprons, and goggles. That is, we want you to invest in things that will keep you and others safe. We won’t make any money from these recommendations. I don’t. But we still try to tell you about all the benefits of these products. We want need you to get them and use them.

Are we selling vaporware? (Vaporware is software, or hardware, that is promised, hyped and even commercialized but never delivered.) How long now have we been promising a vaccine against HIV? We’ve been doing that since the 1980’s. Most vaccine trials have not even reached Phase II, and very few are on Phase III. But we in public health keep hoping for a breakthrough, and we keep advocating for more money to go into research for this vaccine. Because it’s that important.

The final question I’m working out in my brain, and delivering to you, dear reader, is whether or not public health should be done by public agencies. That is, should we privatize public health? In the time that I worked at/with different health departments, two things always stood out. First, how efficiently they did their job. In case you haven’t noticed, budgets for public health are not exactly plentiful. That things like outbreak investigations and responses or tracking of childhood immunizations get done with how little people are getting paid has always amazed me.

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True story.

On the other hand, there are some inefficiencies. Once someone is hired by the government, it’s incredibly difficult to get rid of them. There were a handful of people I met who admitted that they were leeching the system, and they were okay with that. Also, many of the people at the higher echelons of authority within public health are not trained in handling budgets and/or managing people. Many are physicians, or other public health professionals with doctoral degrees, who were introduced to the overall concept of leadership and management but they have no business being either. They might as well be making sandwiches.

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Or being sandwiches.

Maybe, just maybe, a private organization handling the big, huge databases that public health agencies handle would be better, especially if such an organization had a proven record of handling such things. Maybe a well-seasoned CEO would make a better Secretary of Health at any level of government than someone who reached the position more out of seniority or by political appointment than by their ability to do the job.

Maybe.

I believe that the next few decades are going to see a big shift in public health. We had the era before Germ Theory when we dealt with public health issues through witchcraft and snake oil. Then Pasteur, Snow and Jenner came along and shifted the paradigm. Penicillin replaced snake oil. Viruses were discovered and vaccines improved. Things like smallpox, polio, and other infectious diseases did not threaten millions of us anymore… Though some still do. We started to live long enough to get other diseases.

Victory against infectious diseases made us “soft.”

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This soft.

We progressed to the point where we could afford more calories per dollar than ever before, and live to see the consequences. We got things like diabetes and heart disease. If you live long enough, odds are almost even that you’ll get cancer or develop dementia. We went from the era of germs to the era of chronic disease… And we’re about to go into the next one, which I’m wagering will be the era of mental health. But that’s for some other post at a later time.

As that change happens, we in public health will need to adjust along with the public. The next challenges will need new ideas, or the evolution of old ideas. We’ll need science. We’ll need money. And we’ll need a better way to be more efficient with our resources (human and otherwise). Whether or not that efficiency will require a privatization of what has historically been done by the government is up for discussion, especially now that more and more consulting firms and such are doing the work for them.

Thanks for your time.

Header photo by Axel von Wuthenau on Foter.com / CC BY

EpiRen’s Journal Club: Firearm-Related Hospitalization and Risk of Bad Stuff Thereafter, in Washington State, Between 2006 and 2011

This study is pretty interesting…

Researchers in Washington State took hospital records from 2006 and 2007 and found all the firearm-related hospitalizations (FRH) through diagnosis codes. They then matched those cases with hospitalized patients who were not hospitalized for FRH. They used frequency matching, which is one of the various types of matching you do when conducting a case-control or retrospective cohort study like this one. You can read more about matching here. This was not a case-control study, by the way. It’s a retrospective cohort study. There’s a difference, but that’s for some other day.

The researchers then pulled hospital, police and death records from 2006 to 2011 to see if anyone in the exposed (FRH patients) or unexposed (non-FRH patients) were subsequently hospitalized for a firearm-related injury, were arrested, or died. (Of course, you also want to know what they died from.)

So what do you think? Do you think people who were shot once have a bigger risk of being shot again, arrested, or dying than the risk of the non-FRH patients having similar outcomes? You would think so if certain things are true. If, for example, most of the FRH at baseline were from true accidents, there probably is a lower chance of subsequent hospitalization. (You tend to learn from that kind of mistake.) Or, if you live in a state with not a lot of guns, you’ll probably go a while before seeing subsequent exposures.

On the other hand, if you’re a hospital in an urban setting where there is a lot of poverty, inequality, urban disorder, and such… Well, more on that at the end of June. (Wink. Wink.)

To prevent confusion from re-hospitalization related to the first event, the researchers waited 90 days to begin follow-up. They then set their end date as December 31, 2011. If any of the exposed or unexposed individuals were shot again, killed, or arrested, they would count as an event. The number being analyzed here is how many reach that event before the deadline, and if they reach it at different rates based on their characteristics.

Once they accounted for all the possible confounding factors that they could account for, here’s the big take away from their study:

“In adjusted analyses, patients with an index FRH were at significantly greater risk for a subsequent FRH (sHR, 21.2 [CI, 7.0 to 64.0]), firearm-related death (sHR, 4.3 [CI, 1.3 to 14.1]), and firearm- or violence-related arrest (sHR, 2.7 [CI, 2.0 to 3.5]) than those hospitalized for noninjury reasons.”

Not only is your risk of getting shot again, being arrested for a firearm or violence crime, or dying from a firearm-related cause if you were already shot once… You also have higher risk of other outcomes:

“In addition, patients with an index FRH were at significantly greater risk for nonfirearm assault-related hospitalization (sHR, 7.3 [CI, 3.5 to 14.9]) and nonfirearm nonviolent arrest (sHR, 1.9 [CI, 1.6 to 2.3]) than those hospitalized for noninjury reasons.”

The authors do talk about the limitations to their study, which it seems that they thought of thoroughly:

“The primary limitations of this study pertain to the use of existing records that did not include all potentially useful information. First, CHARS data for the index years in this investigation did not include information on race. Prior commentary suggests that among explanatory predictors of crime, the most salient are environmental and socioeconomic factors rather than individual characteristics, such as race, and that the burden of FRHs and death is substantially greater among disadvantaged groups.

Fourth, the determination of psychiatric disorder was based on chart diagnosis using ICD-9 codes rather than chart review. It is possible that a fraction of patients with mental illness did not receive a diagnosis of psychiatric disorder in the hospital setting; therefore, our findings should not be interpreted as pertaining to all persons with mental illness.”

Overall, however, this study has been backed up by other evidence. For example, the University of Maryland Medical Center conducted a case-control study where it was found that:

“Prominent risk factors associated with recidivism were African American male, median age 31 years, unemployed, lacking medical insurance, annual income less than $10000, current drug user, past or present drug dealer, and a positive test for psychoactive substances on admission to the hospital. One hundred seventy-two (86%) of the cases felt that disrespect (called “dissing” in the local vernacular) was involved with their injury.”

This evidence all suggests that, when primary prevention of gun injuries and gun violence is not successful, installing a secondary prevention program in close proximity and working with a trauma unit at an urban hospital would be a very good step in preventing future gun violence. Something like a “full court press” on patients brought in for firearm-related injuries where they are offered help in changing the factors within them and around them that led to their victimization.

How exactly such a program would work, be funded, and be measured as being successful is for a different blog post at a later time.

How Do Anti-Vaccine Advocates React to a Vaccine Bill in New Jersey? Hint: Not Very Well

I won’t bore you with the details because the video is quite good on its own. Basically, NJ legislators in a committee voted to advance a bill for a vote. The bill would require parents seeking a vaccine exemption for attending school to do one of several things. They can get a physician to write a letter that required vaccines are not medically advisable for a child, as is the case for many children who truly do have an allergy to a vaccine component. Or they can show proof that their religion doesn’t allow vaccines (none of the major religions prohibit vaccines, by the way) and sign a notarized attestation to that effect. That’s it.

No one is being forced to be vaccinated. No one is being forced to not practice their religion. The only thing the bill does is keep people from lying about vaccines just because they have some ill-founded fear of vaccines. If anything, I would think that anti-vaccine activists would welcome this bill because it would eliminate people lying about their beliefs and give the world to see the true number of “true believers.” If I were them, which I’m not, and I won’t, but if I were… If I were them, I would put out a press release that would read something like:

“We welcome this bill in the NJ Legislature as it will shine a light on the true size and strength of our anti-vaccine community. This bill eliminates from our ranks those who are simply too lazy to go get their children vaccinated and documents in writing and via notarization those of us who truly stand against science.”

It’s just a draft. Feel free to alter it. 😉

Anyway, that vote didn’t go over well with the anti-vaccine crowd. They kind of didn’t like it:

 

Did you catch that child flipping the double birds at 1 minute 4 seconds? He’s the real victim in all this. Note that he is crying by the end of the video. Sad.

Featured Photo by GôDiNô on Foter.com / CC BY-NC-ND

Whose Fault Is It That I’m Fat?

We were talking in an epidemiology class the other day about the association between obesity and diabetes. It’s a pretty strong association, with a lot of good evidence that obesity causes diabetes. As the students and the professor talked about this, the other teaching assistant in the course took some pictures of us. I was standing at the podium as he took the pictures. When I saw the pictures… Well, I’d be dishonest if I didn’t admit that I was a little bit disgusted by my appearance.*

I’m huge.

I had managed to trend downward in my weight all of 2016 and some of 2017. But then the baby girl arrived and with her came very little sleep. That triggered habitual snacking, poor food choices for the main meals, and a total lack of will to go to the gym or head outside. Little by little, I gained back the weight I lost in 2016 and then some.

Now, I’ve been going to the gym and swimming as much as I can over the last few months, but I traded in swimming, running and cycling each and every single day for a swim every few days. Sometimes I’d skip a week. The pressures of parenting and doctoral school came down hard.

The other problem is that I have a ton of bad food options on the way to the school of public health. Because of the lack of sleep, or because I have to take the baby to daycare, or because of some other thing, I run out the door late and don’t have time to make a good breakfast. As my blood sugar is probably way down from not eating overnight, I crave just about everything I drive by… Or I crave the donuts in the display at the gas station. Before I know it, I’m eating something made with the least natural ingredients, loads of fat and carbohydrates, probably no vitamins and minerals, and I’m eating a lot of it to satisfy the overnight fast.

So I’d posit that it is my fault that I’m fat for not being more mindful about planning meals, choosing better foods when I do stop somewhere, and working out a good schedule with my wife so we can maximize our sleep. The thing is, all of those things become secondary or tertiary, or lower, when the baby gets sick, when the baby needs to go to daycare, when the baby has to be picked up from daycare early or dropped off late.

Planning also takes a back seat to my work on my doctoral dissertation. I have all the data lined up. I just need to find time to write it. This has brought upon me a certain degree of anxiety over getting it done in time for a final defense in the summer. That pressure and anxiety are then dealt with by snacking, or by overeating. So I’d posit that it’s my parents’ fault that I’m fat because they always dealt with stress through eating.

Then there are family gatherings, which we’ve been doing more of now that my wife’s parents and my siblings want to get to know Baby Ren. All of those gatherings revolve around food. We either make a lot of food or order some unhealthy food from the Italian food place down the road. Then we eat and eat and eat while chatting or enjoying the baby’s shenanigans. Calories are not counted at family gatherings, though those calories certainly do count.

So now it’s my culture’s fault.

You see where I’m going with this, right? There isn’t one overarching reason why I’m fat. There are many reasons, and personal choices/responsibility is one of them. But that personal fault is just a small cog in a very big mechanism that had me gaining weight to the point where I really felt sorry for the big Mexican at the podium… So sorry that I went and swam a mile and then did 5 miles on a stationary bike and 20 minutes on a treadmill. (More on this later.)

The same can be said for large swaths of the population who are overweight, obese or morbidly obese. There’s the personal responsibility of being mindful of how much food they’re eating, but then there is the complex mechanism around them. If they live in a food desert, they’re probably not getting healthy meals. They’re probably getting — for very little money — some of the most unhealthy food out there. But that’s all they can get. Also, poverty bring with it crime. Who wants to go for a jog when there’s a real chance of being the victim of a crime?

Like with very many public health issues, obesity and its consequences is a very complex one. There are things that can be done at an individual level, but they’re very much worthless if the environmental influences are not changed. I can work on getting a schedule down, only eating what I cook at home, and exercising more. But none of it will work if I am not able to attain healthy food to cook, or a job that allows me the flexibility to deal with life’s unexpected things (especially with the baby).

The opposite is also true. We can fix an environment so only healthy food is attainable and open spaces for exercise are plentiful. But none of that will matter if we don’t find a way to motivate people to eat better and get moving. This is where both public health and individual medical practices need to join forces. The former can influence large groups while the latter can influence individuals.

So while all that is being sorted out, I’ve gone ahead and done two things. Number one, I’ve made a commitment to find at least one hour each day to work out. Either I work out when Baby Ren is at daycare and I stop at the gym before going to get her, or I put her in the stroller and head out for a walk if the weather is cooperating. If the weather is not cooperating, I get the playmat out and throw some toys on it for Baby Ren to play while I make use of the dumbells in the basement. Just one hour a day is all I need to reverse the weight trend and feel stronger and more agile.

Number two, my wife and I have gotten rid of unhealthy snacks around the house. Instead of grabbing a bag of something processed and munching on it while I work on the dissertation or while I fret about some stressor in my life, there are now oranges and bananas that I can eat to my heart’s desire. (Yeah, they have calories, but they make up for it with fiber, vitamins and minerals.) The next step is to always make breakfast quickly in the morning or having something ready to go from the night before.

Future steps include being mindful of what I buy at places on the way to and from school/work. That one is tricky because the mind can be a tricky thing. You drive by a fast food place and you make a deal with yourself that you’re only getting one thing — or a healthy thing — and, before you know it, you’re getting the supersized fries and sugary drink. This step is going to require some reprogramming, which humans are notoriously bad at doing for themselves.

Finally, I haven’t given up on my goal of doing a triathlon someday soon. It’s just that I can’t do one with all this weight on me because it might actually be damaging to my health. So I’m taking baby steps towards that goal. The mile I swam was more in anger than anything else, and I’ve been paying for it with soreness and some pain. That could discourage me from swimming next time. (I wrote could because I’m not going to let it.) Once the weather gets better, there’s more bicycle time planned, including getting something so Baby Ren can come along. (She’s too young still, though. But soon!)

If you’re struggling with your weight, don’t despair. There are a lot of things out there that are science-based and evidence-based and have been shown to work. For many people, more exercise and a better diet are enough. Others need medication or a medical intervention such as gastric bypass or a gastric band. Still others need psychotherapy because food has gotten a stranglehold on their lives. The first step is to take inventory of what you are doing to gain the weight and/or not lose the weight. Then take that inventory to your healthcare provider.

If you don’t have a healthcare provider, find one. If you can’t find one because they’re not available where you live, or because you cannot afford them, look to other sources of help with nutrition and exercise planning. Many local organizations are tasked with helping people improve their lives and prevent obesity and its accompanying diseases and conditions. There has to be something out there. (Drop me a line in the comments if you really can’t find something.)

When you accept that there is balance that can be achieved in how many calories you consume and how many you burn, and that the imbalance is not 100% your fault (though you do have some control over the situation), you start moving in the right direction. Good luck… We’re going to need it.

*Yeah, I was disgusted by my appearance but only because I realized I’d let myself go. Once I realized that there were sensible and plausible steps that I could take to correct the situation, I wasn’t so disgusted anymore. The fact that I want to fix this is plenty of evidence that I am not disgusted with myself.

America First by Neglecting the World?

As you may or may not have heard, Brenda Fitzgerald, the Director of the Centers for Disease Control and Prevention (CDC), resigned from her post last week. Some point to her investment in tobacco and pharmaceutical companies as the reason why she left. Others don’t care why she left, as long as Anne Schuchat is Acting Director and not someone from the current Administration, and Administration that has promised to cut funding to CDC projects overseas because “America First” and other such nationalist nonsense.

Speaking of nonsense, this opinion piece by Betsy McCaughey really scared the crap out of me. It scared the crap out of me because there are a lot of people (millions, probably) who think like her. Or, rather, who don’t think things through, like she seems to have done. Not only is she displaying the thinking of a nationalist and isolationist, she doesn’t seem to think that diseases overseas can come over and kill us.

She starts off with this:

“Under President Barrack Obama, the Centers for Disease Control and Prevention sent money and staff to distant parts of the globe while neglecting life-threatening health crises under our noses. Dr. Thomas Frieden, who headed the CDC then, is joining a chorus of globalists bashing President Donald Trump’s decision to end funding for the CDC’s overseas projects in dozens of countries. Frieden charges the cuts will “endanger lives in our country.” Sounds scary, but the facts prove otherwise. Trump will spend the money here instead, where it’s urgently needed. As Trump searches for a new CDC director, it’s time to put America first — something the agency has neglected.”

Not to be too picky, but President Obama spells his first name “Barack,” with one R. Frankly, I’m surprised she didn’t throw in “Hussein” for good measure.

Speaking of dog whistles, she does manage to throw in the word “globalist,” which scares a lot of people into thinking that a “globalist” is one of those people who want to take over the world, or who want to give up American sovereignty. In the real world, a globalist is someone who takes into account everything that is going on in the world before making a decision (usually an economic one). This isn’t a bad thing. We’re not living in a world where we’re separated from trouble by two big oceans. You can get on a plane in Madagascar right now and arrive in the US in a matter of hours, bringing Plague with you. So, when the Director of CDC, someone with ample intelligence from overseas sources on what is going on and what is a threat to us tells us that we should worry about “over there,” I’d listen.

It’s like saying that we need to bring all of our troops back from Korea and the Middle East — both potential flashpoints for the next world war — because we need some cops here in Baltimore. You just don’t make decisions like that.

To support her assertion, Ms. McCaughey continues:

“On its core mission — protecting American health — the CDC is an abject failure. It dithered while opioid overdose deaths topped 42,000 and obesity deaths soared to 186,000, according to the National Academy of Sciences. Obesity and opioid overdosing are largely to blame for the sudden drop in American life expectancy.

Year after year, the CDC also pays lip service to curbing hospital infections, but the common infection C. diff now kills 29,000 Americans each year. No progress there.”

No, there has been some progress in the opioid epidemic. There are naloxone and Good Samaritan laws in almost every state now, reducing the number of deaths from opioids. Philadelphia is about to open a safe injection site, which evidence in Canada and Europe has shown to also reduce deaths, increase people looking for rehab services, and also prevent outbreaks of disease (like the one that then-Governor Pence allowed to happen on his watch in Indiana).

There has also been progress in hospital-acquired infections, but, admittedly, that progress is slow. It’s slow because our healthcare system sucks. There are thousands of healthcare organizations that all operate any which way they see fit, and any attempt at regulating them… Well, you know how Republicans feel about regulation.

Ms. McCaughey keeps on keeping on:

“Add flu deaths to the toll from the CDC’s subpar performance. Emergency rooms are overwhelmed during the current outbreak, and 53 children have died. The vaccine is less effective than in some past years, but the bigger problem is how few Americans get vaccinated — only 46 percent. Dr. Peter Hotez of Baylor College of Medicine points to a “poor level of vaccine advocacy” from the federal government. “This could haunt us for the current season,” he adds. Nearly all the children who died never got the vaccine. A new study shows getting it can prevent 65 percent of child flu deaths.”

A couple of things here. First, CDC doesn’t make the influenza vaccine. Epidemiologists from CDC and other organizations around the world (globalist much, Ren?) work together to recommend the best strains to put into the vaccine. Pharmaceutical companies make the vaccines, because capitalism. Unfortunately, they have outdated technology when it comes to the influenza vaccine, so they need a lot of lead time before vaccines against influenza get manufactured. By the time it does, the circulating influenza virus may have already changed.

Second of all, vaccine advocacy is a function of the local and state governments and their health departments. While CDC posts a lot of information about the vaccine and its benefits, it’s really up to the locals to get the word out. After all, they’re the ones giving out the vaccine, not the federal government. (I’m willing to bet Ms. McCaughey would claim that there’s something authoritarian about the federal government carrying out a vaccine program.)

But here’s where Ms. McCaughey really starts to sound unhinged:

“While the CDC neglected its mission here, Obama committed billions to build labs and train health personnel in Africa during the Ebola scare. Billions for a disease that killed only one person in the U.S., and even that person got infected elsewhere.

Obama also allocated $582 million for the CDC’s Global Health Security Agenda serving 49 countries. That fund is running out, and Trump refuses to renew it. Alleluia.”

Ms. McCaughey must have not heard that over 11,000 people died in the Ebola epidemic in West Africa, and that the reason why there was only one death in the US was precisely because men and women from CDC and other organizations risked their goddamned lives to go over there and fight Ebola before it traveled to the rest of the world. Who the hell does this person think they are to whitewash the epidemic like that? An uninformed reader would probably think that the epidemic was no big deal if all they had was McCaughey’s words… And to write “Alleluia” (God be praised) that we will not be able to go help stop diseases outside of the US before they come here?

To hell with her. (I’m a little angry, in case you can’t tell.)

I won’t give you the rest of McCaughey’s drivel because it’s just nationalist propaganda. In her mind, it seems, President Barrack “With Two Rs Because At Least She Didn’t Write Hussein” Obama didn’t do anything to help Americans’ health. She must have missed that part where Obama wanted universal healthcare, with plenty of benchmarks and regulations on hospitals to incentivize them to reduce hospital-acquired infections and require us to go see our healthcare providers (for free!) and get our vaccines and other preventative care.

Oh, no, none of that happened in her world. In her world, like in Trump’s, there is death and destruction everywhere, but Trump will make it right? If we do pull back from global initiatives, it will only be a matter of time before something lands here because we missed it over there.

Ms. McCaughey, this is not a zero-sum game. For us to have better healthcare — which the Affordable Care Act tried to bring us but Trump is determined to destroy — we don’t need to take aid away from anyone. My God, no one comes close in how much we spend on the military. Do you think that maybe, just maybe, we can get some of that cash moved to both fight diseases here at home and abroad?

And if you’re really going to cry because “vaccination rates are abysmal,” then you need to look at Trump’s words about vaccines. He became the anti-vaccine groups’ darling after claiming that vaccines cause autism, and saying that the flu vaccine injects “bad stuff” into you. So, while you go protest the anti-vaccine stance of President Trump, the rest of us in the real world, working for public health, will try to make things work with the breadcrumbs the Trump Administration throws at us while laughing in our face.

The Dark Days of the Republic

CSPAN had some very good programs on about the Civil War in the last few days. Not a bad idea given how quickly everyone forgot what really went on during that conflict. Even the man who perfected the shade of orange that Cheetos wanted to achieve for decades, our President, didn’t seem to understand the difference between George Washington and Robert E. Lee. (Hint: One helped start a country and freed his slaves while the other fought to maintain slavery and split up a country.)

In one of those programs, someone mentioned that the days of the Civil War were “the dark days of the Republic.” Can you imagine? If you lived along the front lines, you went from being a farmer or working in a small town or city to seeing soldiers march through and even burn down your entire town or city. There were no assurances that either side was going to win, so it didn’t matter if you lived in the Union or the South, things were bad.

After the most recent presidential election, a lot of my friends and colleagues were sure that the darkest days were coming. Cuts to the budgets of scientific and public health agencies started to be bandied about by the current administration. They were not worried about their own financial futures or even their careers. You don’t get into public health to become wealthy. They were worried about the further damage to public health that these budget cuts would bring.

As it is, we’re in a very dark place when it comes to public health.

First, maternal mortality actually rose in the United States during a period when maternal mortality worldwide fell. From the New York Times:

“The United States has become an outlier among rich nations in maternal deaths, according to data released Wednesday by the Institute of Health Metrics and Evaluation, a research group funded by the Gates Foundation and based at the University of Washington.

There were 28 maternal deaths — defined as deaths due to complications from pregnancy or childbirth — per 100,000 births in the United States in 2013, up from 23 in 2005, the institute found. The rate in 2013, the most recent year for which the institute had detailed data for the United States, was more than triple Canada’s. The institute is projecting that the American rate dipped in the last two years to 25 by 2015.

Increases were extremely rare among rich countries. In all, 24 countries had one from 2000 to 2015, including South Sudan and the Democratic Republic of Congo, though their rates were much higher. America’s increase put it above a number of poorer countries whose rates had declined with the global trend, including Iran, Vietnam, Russia and Romania.

In all, the American rate was up by more than half since 1990, according to the institute, which uses many data sources, including countries’ vital records systems, to calculate hundreds of health measures.”

In the past, I’ve criticized comparing American fetal and maternal deaths to the rates of other countries because we do surveillance for these things different. I am still cautious about this. However, it’s the trends that are really worrying. Even with all the advances in medical technology, we continue to trend upward. Why? That’s a whole discussion for another post at a later time.

Next, alcohol consumption. From NPR:

“More Americans are drinking alcohol, and a growing number of them are drinking to a point that’s dangerous or harmful, according to a new study published in JAMA Psychiatry this week.

The study, sponsored by a federal agency for alcohol research, examined how drinking patterns changed between 2002 and 2013, based on in-person surveys of tens of thousands of U.S. adults.

They found that drinking, in general, rose substantially over that time frame. Problem drinking increased by an even greater percentage, and women, racial minorities, older adults and the poor saw particularly large spikes.

The findings suggest “a public health crisis,” the researchers say, given the fact that high-risk drinking is linked to a number of diseases and psychiatric problems, as well as violence, crime and crashes.”

Again, the problem here is the trend and the direction of the trend. With the large underfunding of mental health problems, and with alcohol addiction having an enormous mental health component, this is only going to get worse. And probably not just with alcohol but with other forms of “self-medication.”

And then, as we all know by now, we’re in the middle of an epidemic of opioid drug use and abuse. The Mayor of Nashville recently announced the death of his son from an overdose. The son of a golf celebrity also recently died from an overdose. Based on some of the preliminary mortality data coming out from colleagues at different health departments (state and local), the situation is bad. It is taking the lives, livelihoods, and futures of many young people in the United States.

It’s not just the attack on public health from the White House, either. The Governor of Maine keeps putting up roadblocks to access to narcan — an opiate antagonist drug given in an overdose in order to save the person from asphyxiation — despite all the evidence that narcan programs save lives and buy time for the person with an addiction to find help. The same kind of weird beliefs are shared by decision-makers at the local level, like a sheriff in Ohio.

So are these the dark days of the Republic? Maybe. Certainly, there have been dark days in this Republic for each generation. My father’s generation had the Cold War, the Kennedy Assassination, the Vietnam War, and the Nixon Administration. His father had World War II, the Korean War, and the Great Depression. In terms of public health, my grandfather grew up in times when epidemics of vaccine-preventable diseases killed off groups of children by the dozens in our ancestral town. Dad grew up during the big Rubella (German measles) outbreaks that left so many children with disabilities or death.

In a way, yes, these are our dark days.

It is then our responsibility to pull ourselves out of these dark days by working harder than ever. We inform policymakers of the science-based things they need to do to counter the trends described above. We work with local, state and federal agencies to make the most out of what we have. In essence, we take what little we will have, we make it work, and we make sure that the benefits of those things we do reach as many people as possible.

Yeah, we’ll have these dark days, and there will be more dark days ahead in future generations. But there’s also plenty of good people to be lanterns in the dark.

What we should have been doing all along: Translational Epidemiology

When I was applying to get into the DrPH program, the interviewer — who would later become my academic advisor — asked me for my thoughts on Translational Epidemiology. Translational Epidemiology (TE) is the use of epidemiology in different stages between identifying a population-level problem to identifying a solution for it, to evaluating what that problem was. It is presented in four phases:

“In T1, epidemiology explores the role of a basic scientific discovery (e.g., a disease risk factor or biomarker) in developing a “candidate application” for use in practice (e.g., a test used to guide interventions). In T2, epidemiology can help to evaluate the efficacy of a candidate application by using observational studies and randomized controlled trials. In T3, epidemiology can help to assess facilitators and barriers for uptake and implementation of candidate applications in practice. In T4, epidemiology can help to assess the impact of using candidate applications on population health outcomes.”

Take this a little further, and a little to the left or right, and you have epidemiology and epidemiologists who guide policy. They identify the problem, look at the evidence for solutions, and then they evaluate the implementation of those solutions. When done right, the decisions made are science-based, and they are the right decisions for the right time.

Dr. Moyses Szklo, a professor at Johns Hopkins and also the editor-in-chief of the American Journal of Epidemiology, gave a talk at Harvard about translational epidemiology:

“Epidemiology is the study of patterns, causes, and effects of health in defined populations. Szklo defined “translational epidemiology” as the effective transfer of new knowledge from epidemiologic studies into the planning of population-wide and individual-level disease control programs and policies.

In addition to Snow’s famous work, Szklo cited a number of other public health policies influenced by epidemiologic findings, including cigarette advertising bans, food labeling requirements, and air pollution standards.

Szklo also discussed a variety of issues to think about when “translating” epidemiologic knowledge into interventions, programs, or policies. For example, he said, it is important to consider whether or not a particular association between one risk factor and a disease is “confounded”—if it is to some extent questionable because there are one or more other risk factors also at play.

“Translational epidemiology is not an exact science,” Szklo noted. “It’s judgment.”

In a question-and-answer session at the end of the presentation, HSPH’s [[Walter Willett]], chair of the Department of Nutrition and professor of epidemiology and nutrition, asked what Szklo thought of the notion that epidemiologists should not become involved in policy because it makes them less objective in evaluating their data.

Szklo acknowledged that while such involvement might pose a problem, “I don’t think it’s possible to talk about development of [health-related] policies without strong input from epidemiologists.””

I agree. It may be difficult to separate subjective judgment from objective evidence, but there’s really no good way around it. Policymakers need to act on the best science and evidence instead of acting on their gut instinct. (Gut instincts are notoriously off most of the time.) They need to be surrounded by people who know how to collect, analyze and interpret the wealth of information out there on a myriad of issues.

Unfortunately, there are plenty of policymakers who want nothing to do with science, evidence, or even with reality. That, or we epidemiologists shy away from having conversations with policymakers. We think that policy is not our purview, and that our purview is just to apply for research grants, do the research, get it published, and move on to the next bit of research… When, for all that time, we should have been doing the research, publishing the results, and then advocating for policy changes based on those results. We should have been calling our members of congress and telling them to do something based on what we found.

Because we haven’t been doing that, we ended up with a crappy healthcare system in the beginning and a very imperfect solution in the Affordable Care Act. Furthermore, because the policymakers think they know better and won’t listen to experts, we have the atrocity of a bill that cleared the House of Representatives recently. And don’t get me started on how the US Government has responded to Ebola, Zika and during the H1N1 influenza pandemic. Very few epidemiologists were being listened to then.

Non-Biostatistician, Non-Epidemiologist Tries to Complain About Biostats and Epi

Don’t you love it when people who don’t know better think that they know better, and then they end up making fools of themselves? There is a particularly interesting anti-vaccine man by the name of Brian S. Hooker. He has a doctorate in biochemical engineering, according to his Wikipedia page. Maybe you remember BS Hooker from his foray into epidemiology, which went fantastically terrible. So bad was his “re-analysis” of a study looking into the MMR vaccine and its association with autism that the journal in which his “re-analysis” was published had to retract the paper and apologize for ever letting it into the wild.

I also tore the paper a new one here, here, and here.

Anyway, BS Hooker has decided to dive into biostatistics this time. He wrote a letter to the editor about a study looking into the influenza vaccine given to pregnant women and autism diagnoses in children born to those women. Here’s what he wrote. It’s a bit long, so bear with me:

“To the Editor: The JAMA Pediatrics article by Zerbo et al reported a statistically significant association between the administration of the maternal influenza vaccine in the first trimester of pregnancy and the incidence of autism spectrum disorder. The authors stated that the analysis adjusted for covariates yielded a P value of .01 when applying a Cox proportional hazards regression model to the data.

However, this P value was erroneously adjusted to reduce the possibility of type I errors by applying the Bonferroni adjustment for 8 separate analyses completed on the data sampling. Using this adjustment, the authors stated that this association “could be due to chance (P = .10).” In this instance, it is inappropriate to apply a Bonferroni adjustment because the associations were highly interdependent, contrary to the independence assumption used by the adjustment. This can be seen by the fact that knowing the results for each trimester will yield the result for the total period.

In the Zerbo et al article, comparison is made of the autism spectrum disorder incidence in each of 3 groups depending on the trimester in which the mother received the influenza vaccination against the autism spectrum disorder incidence in a “zero exposure” control group. Rather than a set of independent tests where “set A” is compared with “set B,” “set C” is compared with “set D,” and so on, in this instance, all maternal vaccinated data sets were compared with the same control set (ie, the unvaccinated sampling). In addition, in a fourth comparison, 3 sets were combined for a comparison of vaccination in any time during pregnancy to the unvaccinated control set. Thus, the full data set in this case was a dependent combination of the data from the first, second, and third trimesters in pregnancy.

Bland and Altman 1995 warned against the use of the Bonferroni adjustment when associations are correlated and cite the danger of missing “real differences.” The study authors apply a degree of caution regarding the autism spectrum disorder finding for influenza vaccination in the first trimester of pregnancy by stating that the findings “suggest the need for additional studies on maternal influenza vaccination and autism.” However, the application of the Bonferroni adjustment in this instance is inappropriate. Furthermore, the use of any adjustment for the first trimester is especially questionable because it has long been suspected a priori that an effect, if any, is likely to be concentrated in that trimester.”

My emphasis in bold.

The explanation to a lay audience is the following… There are two big types of errors you can make in conducting a study, Type I and Type II. A Type I error is when you fail to reject the null hypothesis that there is an association between an exposure and an outcome when, in fact, there is no association. In essence, you have a false positive. A Type II error is when you fail to reject the alternative hypothesis that there is no association when, in fact, there is an association. In essence, you have a false negative.

There is always a balance between these two errors, but it’s the Type I error that you want to avoid the most. (This all depends on the impact of your study, but, for academic purposes, it’s the Type I error that is the big one.) If you commit a Type II error, well, you might get to try again at a later time. In the gibberish above, BS Hooker is trying to say that, in making their adjustment, the authors of the study not only did away with a statistically significant result (p-value less than 0.05), but they also increased the chances of false negatives happening. (They did increase that chance of false negatives. More on that later.)

Furthermore, BS Hooker warns that there was a violation to the assumption of independence between the observations. The observations, in this case, were giving the influenza vaccine at trimester 1 or 2 or 3. As you can imagine, there is a dependence between these three observations since, if you don’t give the vaccine at trimester 1, then you must give it at 2 or 3. If you give it at 2, then you must give it at 1 or 3. If you give it at 3, then you must give it at 1 or 2. However, the problem with the last two statements is that you cannot go back in time. That is, if you don’t give it at 2, there’s no way you can go back and give it at one. If you don’t give it at 3, you’re not giving it at all.

Thus, there is independence, of sorts. The analysis is valid. (More about the “dependence/independence” thing later.)

The other thing that I found interesting was that BS Hooker wanted to compare one group to another, one by one. This is the same mistake he made in his “re-analysis” of the MMR-autism study. Doing it that way misses the interactions between different factors in the analysis. That’s why you do the more complex analyses, the less “simple” statistics that give you more realistic results.

What is that Bonferroni Adjustment he speaks of, though?

In a study, you want to keep the chance of a Type I error at less than 5%. That’s the p-value. It’s basically saying that you’d have to replicate the study 100 times to see 5 or more false positives, which is unacceptable. If you have a p-value less than that, you say that the probabilities of your association being a false positive are very low, so your results are “statistically significant.”

But what if you’re doing a bunch of different comparisons at the same time with the big dataset? This paper explains it very well:

“Say you have a set of hypotheses that you wish to test simultaneously. The first idea that
might come to mind is to test each hypothesis separately, using some level of significance α. At first blush, this doesn’t seem like a bad idea. However, consider a case where you have 20 hypotheses to test, and a significance level of 0.05. What’s the probability of observing at least one significant result just due to chance?

P(at least one significant result) = 1 − P(no significant results) = 1 − (1 − 0.05)20  ≈ 0.64

So, with 20 tests being considered, we have a 64% chance of observing at least one significant result, even if all of the tests are actually not significant. In genomics and other biology-related fields, it’s not unusual for the number of simultaneous tests to be quite a bit larger than 20… and the probability of getting a significant result simply due to chance keeps going up. Methods for dealing with multiple testing frequently call for adjusting α in some way, so that the probability of observing at least one significant result due to chance remains below your desired significance level.”

The Bonferroni Adjustment takes care of that by dividing 0.05 (or whatever your desired level of probability is) by the number of comparisons (hypotheses) being tested. In the case of the paper that BS Hooker seems to be trying to discredit, the formula is more like this:

P(at least one significant result) = 1 – P(no significant results) = 1 – (1 – 0.05)8 ≈ 0.34

So, in this study, you’d have about a 34% chance of committing a Type I error. That’s pretty high. Imagine the consequences of a false positive in this case. Influenza can kill a pregnant woman and her child. At the very least, influenza in a pregnant woman is serious business. Using the Bonferroni Adjustment, the authors correctly diminished the probabilities of a false positive. Yes, they increased the probability of a false negative, but what’s the harm in that? What’s the harm in seeing no association between the influenza vaccine and autism when there might be one? Probably none, given that autism is nowhere near as bad as, say, death… Or all the other complications from influenza.

But the true sign of an anti-vaccine believer is to compare autism to death, to say that autistic children might as well be dead. That’s where they make their bread and butter. It’s a trope as old as the false association between vaccines and autism.

You don’t have to take my word for it, though. The authors of the study slapped down BS Hooker’s assertions themselves in a response to his letter to the editor. A response that, in my opinion, didn’t need to be done. BS Hooker is not a biostatistician, nor is he an epidemiologist. Why he continues to dabble in these disciplines is beyond me, though some have suggested to me that he’s doing it because vaccines causing autism are his only lifeline to a cash reward in the vaccine court, a claim denied last year. If he can somehow tie his child’s autism to a vaccine — any vaccine, at this point, given how he’s gone after the MMR and now influenza vaccines — maybe he can revive his claim?

Maybe.

Anyway, here’s the authors’ response, my emphasis in bold:

“In Reply: We appreciate the comments presented by Donzelli and colleagues and Hooker about our study titled “Association Between Influenza Infection and Vaccination During Pregnancy and Risk of Autism Spectrum Disorder.” Statisticians and epidemiologists have debated at length whether this type of epidemiologic study should adjust for multiple testing, and no consensus has been reached. We used the conservative Bonferroni adjustment following suggestions received from JAMA Pediatrics reviewers. We agree with Donzelli et al and Hooker that the 3 trimesters are not independent of the entire pregnancy period. However, a less-conservative adjustment for multiple testing, accounting for the dependence of the entire pregnancy on the trimesters, would still yield a P value of .07 or higher, which should not change interpretations of our findings.

We do not see enough evidence of risk to suggest changes in vaccination guidelines and policies, but additional studies of maternal influenza vaccination during pregnancy are needed.”

(Donzelli et al, by the way, wrote a letter to the editor that was less fallacious than BS Hooker’s, in my opinion. You can read it here.)

But wait, the authors admit that there was dependence. Yeah, that’s why I wrote that there is independence “of sorts.” See, the design of this study leads to some dependence between the time periods when you give the vaccine, but, because of temporality, it leads to independence because you can’t say that women were given the vaccine in the first or second trimester because they were not given it in the third. Likewise, you can’t say that giving the vaccine in the third trimester caused them not to get it in the first or second… Or that not giving it in the third assured that they got it in the first or second. And so on.

Policy is not only about statistical significance.

In the end, good policy decisions are not made solely based on one scientific study. Heck, good policy decisions sometimes are not made based on a hundred studies. Good policy decisions require people who can see the forest for the trees, the big picture, if you will. When the government was looking at the anthrax vaccine for use in children, Dr. Paul Offit (a “vaccine industrialist,” according to his detractors) opposed using the vaccine in children. It’s not that the vaccine wouldn’t be safe or effective in children. It’s just that the risk of them catching anthrax is negligible compared to, say, a soldier on the front line of a war where the opposing army is known to have a bioweapons program.

In essence, you weigh the pros and the cons of a vaccine both under ideal conditions (i.e. clinical trials and such) and under real-world conditions (i.e. taking into account the risk of the disease in the general population). You certainly don’t do it based on one study, Bonferroni adjustment or not, and you certainly don’t do it based on the thoughts of someone who is not a biostatistician nor an epidemiologist, and someone who likes to do biostatistics the “simple” way.

(Special thanks to The Spaniard for his review of this blog post for accuracy regarding the biostats.)

Navigating the Political Seas

Imagine for a minute that you are a resident of Puerto Rico. If you were born there, then you are a citizen of the United States. However, your vote for President doesn’t count since Puerto Rico doesn’t have any votes in the Electoral College. Congress makes laws that affect you but you don’t have any representation there. A lot of mainland-born Americans live and spend their money on the island, but, for census purposes, they’re not counted as residents. So you have an island with a lot more people than what is counted and not as much tax remuneration to provide services.

That would cause some sort of resentment against the Federal Government of the United States, right? Maybe just a little bit?

Now, imagine that you are hit with a pretty serious disease outbreak like influenza in 2009, chikungunya in 2015, or Zika in 2016 (and into this year). Imagine that you need help from one of the most elite public health organizations in the world, but that organization happens to be an agency within the federal government that also treats your people like second-class citizens.

Yeah, it’s a political minefield.

That’s pretty much the situation under which people from CDC are working with their colleagues in Puerto Rico. I’m not going to get into the details of what is going, of course. I will tell you that colleagues are working together, and that the collegiality between them is strong. It has to be because so many of them (99%) are there to help people, save lives.

They would probably do a much better job if they didn’t have to navigate the political seas on top of everything else. However, that’s the nature of the job, right? If you work in a government agency, and the government is run by elected officials, then you’re going to be at the whims of whoever those elected officials are. I mean, just look at the mess of things that are going on when we went from a center-left Obama Administration to a far-right Trump Administration.

spilled-milk
Thanks, Obama!

Who suffers, though? Not the people working. (Maybe a little bit.) The people who are the recipients of the services are the ones who suffer. As we move into an era of trying to kill any clinic that dares offer abortion services, women who use those clinics for healthcare will suffer. Their children will suffer as well since good healthcare starts before birth. Their families will suffer when those women are too sick to help provide for them, or die from preventable diseases like cervical cancer.

There are also the effects on morale that these situations have. People don’t work as efficiently because they find themselves walking on eggshells. Unless they’re like me and just stomp on those eggshells, of course. Or, they stop communicating with those who need to know things because they are afraid of the repercussions of saying something that the bosses won’t like. And so on and so forth.

Gosh, I wish public health was completely divorced from politics. Unfortunately, public health — at least in the United States — is a function of the government. That, and people would never allow public health to be run by a for-profit business (i.e. privatized). But maybe they should?

Whether they should or not is best for another post at a later time. For now, I continue to wait for that one 24-hour period where Mr. Trump doesn’t embarrass us as a nation. Maybe by day 100 he’ll get the hang of being Putin’s puppet president.

Public Health is in a bit of a pickle over the nasal flu vaccine

About a week ago, the CDC Advisory Committee on Immunization Practices voted to not recommend the use of the Live-Attenuated Influenza Vaccine (LAIV). This vaccine is given as a spray up each nostril and it is sold as FluMist in the United States. Here’s what the reasoning was:

“In late May, preliminary data on the effectiveness of LAIV among children 2 years through 17 years during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network. That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3 percent (with a 95 percent Confidence Interval (CI) of -49 percent to 37 percent). This 3 percent estimate means no protective benefit could be measured. In comparison, IIV (flu shots) had a VE estimate of 63 percent (with a 95 percent CI of 52 percent to 72 percent) against any flu virus among children 2 years through 17 years. Other (non-CDC) studies support the conclusion that LAIV worked less well than IIV this season. The data from 2015-2016 follows two previous seasons (2013-2014 and 2014-2015) showing poor and/or lower than expected vaccine effectiveness (VE) for LAIV.”

If you’ve been a reader of this blog for a while, you should know that I don’t think there are any sacred cows when it comes to vaccines. In essence, I don’t blindly defend vaccines, contrary to what the antivaxxers claim. You should also know that we — epidemiologists — kind of saw this problem coming, especially after the Center for Infectious Disease Research and Policy published a report where the main conclusion was that we need a game-changing vaccine against influenza because what we have right now is not nearly as good as we need it to be. I mean, for crying out loud, a 3% effectiveness?

Effectiveness, by the way, is the real-world protection a vaccine provides. Efficacy is what the clinical trials (under near-perfect conditions and with a very homogenous population) tell you about the vaccine. Here’s a really good presentation from WHO on how these two concepts are used in vaccine policy.

Anyway, this recommendation against the LAIV puts public health in a bit of a pickle because it’s a vaccine that, for the most part, is marketed for use with children (although it can be used for anyone between 2 and 49 years of age). Because it doesn’t involve a shot with a needle, a lot of parents ask for it for their children, and a lot of children are okay with taking it.* Also, because many schools have policies against forcefully restraining a child, they’re more amenable to giving the LAIV over the injected vaccine. (Some kids are much stronger than they seem when it comes to holding them in place for a needle in the arm.)

In other words, no fuss, no muss.

So what does public health do now? Do they continue with the vaccine clinics in the fall as scheduled knowing that there will be people who will not want the injectable vaccine for their children? Do they cancel the clinics and just hope that parents will talk it over with their pediatricians on whether or not to get the LAIV although it’s not recommended? And what about insurance companies? Will they pay for the LAIV when it is not recommended this upcoming season?

What’s really complicated is that this all has to be communicated to everyone in a way that is understandable. We in public health need to explain efficiency and effectiveness, the science of the flu vaccine in general, the science of the LAIV versus injectable vaccines, and why the LAIV may come back next year. Sprinkle on top of that the fears that antivaxxers bring to the party and…

And it’s going to be an interesting flu season.

*This is anecdotal because I’m not able to get the numbers right now. But, trust me, A TON of parents ask for the spray over the shot for their kids.