Uninformed or Misinformed? The Media on Naloxone

A headline from USA Today came across my desk today “Drug company raised price of life-saving opioid overdose antidote more than 600 percent ” with the simple comment “this is evil” from the person who shared it. My ears immediately perked up, because ‘pharmaceutical pricing’ regularly falls into the category of things the news media is seemingly incapable of reporting on accurately. I was not disappointed.

The story (which has generated all manner of hate-click headlines this morning), is about a company Kaleo implementing a significant (600%) price increase on one of their products, Evizo, two years ago. Evizo is a naloxone autoinjector, which means that it’s essentially an epi-pen for opiate overdoses. It’s a pre-dosed, self-sheathing syringe that delivers naloxone, which is an opiate reversal agent.

Naloxone, patented in 1961, is far outside of any patent protection, which means it’s available from several different manufacturers in both branded (like Evizo and Narcan) and generic variants. Naloxone is sold in a variety of forms, most notably: vials for intravenous administration in hospitals (~$25/dose), and pre-dosed intramuscular autoinjectors (like Evizo), and pre-dosed nasal sprays (like Narcan, ~$125/dose). The pre-dosed auto-injectors and pre-dosed nasal sprays are what is used by police officers, EMTs, and lay-people.

The thing that makes Evizo different from its competition is that the autoinjector pack speaks to the person using it, giving them instructions for administration much like modern AEDs do. This, to begin with, made it a niche luxury product. Even before the price increase, when it was launched at $575, it was still some 300% more expensive than the brand-name naloxone nasal spray Narcan ($125).

I was among the first groups of EMTs to be trained to administer naloxone in NJ in 2014-15. We were trained on the nasal spray. Everywhere I’ve subsequently worked and every public-access program I’ve ever participated in has trained people exclusively on the nasal spray. This is of course anecdotal, but I’ve never seen a naloxone autoinjector in the field.

Which brings me to my gripe with this USA Today article, and most of the news coverage of this price hike today. What people think when they read a headline like the USA Today headline is that “those evil pharmaceutical companies raised the prices again, now it’s going to be impossible to afford the drug that saves peoples lives during ODs” which is not what happened. But USA Today knows that people will think that, and get angry, and share the article.

What happened is that one of at least six companies which manufacture naloxone raised its prices two years ago. This is not like if the only electricity provider where you live decided to triple its prices, this is like if Apple decided its new iPhone was going to cost $6,000. Weird move from a business perspective, but there are still a lot of other options for high-quality phones that don’t cost $6,000.

The Apple comparison isn’t even a particularly good one because unlike Apple, Kaleo represents a very, very, small market share. The latest information I could find was from 2015, but as you can see in the figure below, Kaleo’s market share was that black sliver highlighted in 2014-2015.

So what, exactly, is happening here? Kaleo is a private company, but it appears to have been struggling. A 3rd party audit available from the SEC shows Kaleo was bleeding money between 2014-2016 , posting an average net loss of $32m for the three years.

The price increases were likely a gamut by Kaleo to get pharmacy benefit managers, insurers, and government healthcare programs to pay more for Evizo. A hundred page congressional report on this saga indicates this is the case. This one in particular seem to have ended up being a way of getting Medicare to reimburse thousands of dollars for Evizo while private insurers negotiated lower prices or dropped coverage of Evizo entirely. However, despite the pricing games and seeing some growth in sales, per the report, Kaleo has never turned a profit on Evizo.

This is an important point of clarification to remember any time you see a media report on drug prices: people, individuals, almost never pay the ‘sticker prices’ (also known as the wholesale acquisition cost or WAC). Low-effort ‘news stories’ can get millions of hate-clicks and shares because the American public does not generally understand this. When these stories get reported, the prices quoted are the prices that pharmaceutical companies are charging your insurer for your prescription, it’s not the price you pay at the register in the pharmacy.

The price you pay at the pharmacy is based on your plan, what your insurer covers, how much they cover, and contracts with the drug companies. Especially in a case like naloxone where there are other options, Kaleo’s pricing did not have the overall effect on the price of naloxone that the headlines for this story would imply.

I wrote this little overgrown Facebook comment up during my lunch break and tidied it up after work, I am not a journalist, I do not have an editor. Yet, I was able to find some important clarifications. Reporters, editors, and headline writers: be better. I understand the economics of journalism are a little wonky right now. That said it’d be better if you published nothing rather than put out stories like this that obscure an issue more than explain it.

You know you are misleading people when you say: Drug company raised price of life-saving opioid overdose antidote more than 600 percent. You’re not strictly lying, but you know that that headline will give most people who see it the wrong impression.

You know that people are not going to look at that headline and think “one of a half dozen manufacturers, this one manufacturing a specialty product, raised their prices two years ago”. You know that thousands of people will share the article angry or scared without even reading the article, and even those who skim the article may come away with the wrong impression. Be better. I don’t know how you expect anyone to trust your name or your brand if your headlines are misleading and your articles require additional research to have a full picture of the story.

All Bleeding Stops Eventually

Responding to the Criticism of Stop the Bleed Training

The Department of Homeland Security is pushing a new public awareness program called ‘Stop the Bleed’ which is trying to train as many citizens as possible in basic bleeding control techniques. This is partially in response to the mass shootings we’ve been having. A lot of the casualties from these events are the result of blood loss. Many lives could have potentially been saved if the victim’s bleeding had been controlled earlier. In the first minutes of an active shooter situation, the police will be entirely concerned with neutralizing the shooters. It will likely be five to ten minutes (at least) after the initial police response before medical personnel move in to start treating victims. For many this will be too late. If more people were trained in bleeding control, they could potentially save their own lives or that of those around them.

The criticism of these programs is always the same. That training like this ‘is turning our schools into war zones’, that this is ‘normalizing mass shootings’, or that this will somehow preclude whatever your preferred action on gun control is because we’ve ‘accepted mass shootings as part of life.’ Frankly, I don’t understand this view. When I say I don’t understand, I mean I have difficulty comprehending how any adult can seriously hold this view. But it’s clear that that is more about the limits of my own imagination or capacity for empathy since many serious people do seem to genuinely hold that view, so let me explain myself.

I do this (emergency preparedness and emergency training) professionally. I run CPR and bleeding control courses at work on a semi-regular basis. I participate in creating emergency plans and procedures. In the event of a crisis or emergency, I would be part of the response. My department is tasked broadly with preparing the organization for an emergency.

The fundamental reality of my field is that we cannot eliminate all risk to everyone at all times. It’s simply not possible. We cannot offer complete protection or complete safety. Public safety typically has extremely constrained resources & budgets, especially when, like me, you are one operational department in a large organization. I serve approximately 19,000 students, faculty, and staff across more than two dozen campuses. My colleagues and I have to decide how best to allocate departmental resources in order to maximize safety and preparedness.

Armed guards (instead of unarmed) are a regular suggestion, even from the political right, in lieu of something like active shooter training or stop the bleed training. So, let’s dig into that. In Manhattan, the going rate for an armed guard is $24 an hour. I teach bleeding control courses, they take about an hour, and if I’m giving away tourniquets to the participants, the cost is around $25 per student. For those who are ahead of me, one-year of 24/7 coverage from one armed guard at one campus would cost $105k. If we had a $105k excess budget (we don’t but a guy can dream) which of these would provide a larger benefit to my organization and the population I serve?

  1. Employing one armed guard at one campus for one year
  2. My department training an average of 12 people a day for a full calendar year (4,380 people) in basic bleeding control and hands-only CPR, and giving them all a tourniquet

Which of those would provide the largest net-positive? I know which one I would go for. We train 4,380 people, say the training sticks with 60% (2,628 people), who will hopefully be with our organization for years to come. Those 2,628 will also be out walking around, living their lives, with that lifesaving training in their heads. It seems like a no-brainer compared to sinking $100k into a single point of armed security for one year.

This is obviously bar-napkin math, but you begin to see why people who do what I do often pursue what to the public may seem like counterintuitive aims. “Why are we spending all this money on training when we could invest it in armed guards to keep people safe?”. Mass-training programs, like the now decades-long push to teach the public CPR, provide a lot of benefits compared to the relatively modest investment required.

The connected criticism, which comes especially frequently when this training is done at schools, is about not burdening ‘children’ with such things, about it triggering anxiety. As a physician said to me on twitter criticizing bleeding control training being given to high school students: “A child should never have to worry about trying to save another child. A child should never be in that situation in the first place.”

Leaving aside the question of if high school students are “children”, I agree with the impulse. It is important not to unnecessarily terrorize people, especially children, with things (like mass shootings or cardiac arrests) which are very unlikely. I should differentiate between “mass shooter training” and bleeding control training. Mass shooter training (if a shooter comes into the school this is what we’ll do) is something which I do not believe we should be doing with young school children. It effectively terrorizes children over something that is extraordinarily unlikely, creating a fear that need not exist. It’d be like doing home invasion drills with your children, why would you want to put that thought in their heads before they are old enough to process the probability of ever being a victim of a home invasion?

But to teach someone a skill is not to terrorize them. Teaching someone a skill, showing them how to fix something, is empowering. Every child (and certainly every adult) should know how to use a tourniquet and do CPR from the point they’re physically strong enough to do those skills. It’s not ‘normalizing’ violence or injury, it is empowering people to be masters of their own fate.

The conflict here is between normative and descriptive ways of engaging with the world. “There should be no mass shootings” is a normative claim, “but there are mass shootings” is a descriptive one. We must, at this level, engage with the world on a descriptive basis. We must engage with the world as it is, not as we wish it to be. This is what people in my field do. We are given limited resources and an impossible goal. We take honest stock of the world as it exists, and work backward towards what we can do to make a positive impact in it.

I do not have the luxury of saying in response to mass shootings “well there shouldn’t be shootings” or “we should ban guns” or any such macro-level political ‘solutions.’ I am tasked with doing something productive for the population I serve in the face of this risk. Calls for mental health funding, red flag laws, media reform, or various flavors of gun control are all well and good but are part of a separate discussion. Those long-term systemic policy discussions are not going to help the victim of a shooting who’s bleeding out on the ground while the police are searching for the shooter. But bystander or self-intervention to stop the bleeding could.

This is empowering. We live in a political environment where millions of Americans feel impotent and helpless to be able to effect change around these systemic problems. But this is something you, or anyone, can do to have a positive effect on the world. Anyone can learn to use a tourniquet or pack a wound from YouTube videos (if you’re in NYC I’ll be more than happy to teach you how in person over lunch). This is something everyone can do today to mitigate the tragedy of mass shootings and violence or injury of all kinds. Regardless of what our politicians do or don’t do, all of us citizens can grab this bull by the horns and say “I am going to learn how to do this, and I may someday save a life with this knowledge, I am going to take this step to reduce the amount of tragedy in the world.”

The final criticism, which often comes from professionals, is that we can’t expect “lay people” or “civilians” to do these things, let alone do them correctly. They, rightly, point out that out of people who learn CPR, only a percentage of them will actually perform CPR if the time comes, and only a small percentage of that group will do it correctly. This is true, but it is all the more reason to give better training to more people to increase the numbers of people who know these skills, choose to do them when needed, and do them correctly.

Even professionals fumble and make mistakes, or freeze entirely, especially the first time they do something in the field. This is why medical training consists of repeated simulation practice and then graduated, supervised, practice in real life. Further, it’s worth noting a lot of physicians and medical professionals are spectacularly bad at skills they rarely or never use in their practice. A dermatologist, despite his MD, is not going to necessarily be any better at using a tourniquet than a janitor who went through a stop the bleed seminar. A veteran nurse who works in a pediatrician’s office is not necessarily going to be any better at CPR than one of the college students I trained this fall.

Mark Bennett said succinctly in a discussion on twitter “If we are certain we will attack, we may attack. If we think we will run, we will certainly run.” It is not about getting 100% of the training to stick with 100% of the people. This is about increasing the probability that if I find myself bleeding out on the floor of Penn Station during rush hour there will be someone in the crowd who knows how to control bleeding and jumps into action. The fact of the matter is there will not always be a professional present. There will not always be an EMT or a Police Officer there when you need them. Sometimes, it will be up to you, the person going about their day who is all of a sudden tossed into chaos. Massive bleeding and cardiac arrest are two situations were seconds count, and the victim won’t have minutes to wait for an EMS response.

If professionals like me go into this exercise thinking “regular people will never do this”, then regular people certainly will not. If we breed helplessness, and tell people there’s nothing they can do, just wait for help, then helplessness is what we’ll get. However,if we go into this thinking “this is a skill regular people can master and will use in an emergency, and save lives” then there is a chance they will, and that, is a chance I am willing to take.

You can find this post cross-posted on my LinkedIn

Health Care Rationing and Death Panels

Sarah Palin got a lot of attention when she claimed that the Affordable Care Act would result in “death panels.” Like many partisan issues, liberals immediately defended the ACA, while conservatives flocked to Ms. Palin’s side. As in many cases, both sides missed the mark—and an opportunity for having a productive discussion. “Death panels” have recently been resurrected from the political grave now that Republicans are beginning the ACA rollback. We shouldn’t miss the opportunity this time to discuss the realities of the healthcare system.

Ms. Palin was right, in a sense, when she said that the ACA would set up “death panels.” She was right in that there would be a government mechanism—perhaps a panel, perhaps regulations, which would ration health care and would inevitably end in people living or dying. She was wrong to insinuate that this didn’t already exist in some form and that there was some way to organize health care so that rationing care wouldn’t exist.

All health care systems ration care in one way or another. They must. No system can afford to pay for all treatments for all people. So there has to be a mechanism for deciding who gets what—which patients will receive which treatments. This is an uncomfortable reality for most people, but it’s a reality nonetheless.

We already do this with organ transplantation. There are medical criteria for being placed on an organ transplant list and certain criteria which can prioritize one case over another. This is because there are more people who need transplants than organs available to transplant.

We do this at the insurer or payer level with specific medications or treatments. In 2014 Gilead Sciences released Sofosbuvir, a breakthrough medication which effectively cured Hepatitis C (HCV) faster and with fewer side effects than any other therapy. The aggregate cost of a Sofosbuvir treatment, however, often exceeds $100,000[1]. Due to the high price point, insurance providers and public health-care systems (Medicare, Medicare, and the VA) are reluctant to pay for it if there’s any other option. Due to this, Sofosbuvir was placed in a special category of medications which required “Prior Authorization,” meaning that before this medication could be prescribed, it needed to be approved by the insurer.

Three of the largest healthcare providers—Humana, Anthem, and Aetna–all have published requirements that state that patients must be in an advanced state of liver disease before treatment with Sofosbuvir can be approved. Advocate groups say that requirements which do not to allow patients to receive the newest, best treatment available (there are other treatments available for HCV) are cruel. Insurers say that they are trying to prioritize their spending on the most critical patients. Both of these are legitimate concerns.

The question we should ask as a country is not: “Should care should be rationed?”; because care has to be rationed in one way or another. Rather, the questions we should ask are: “Who should be making these decisions?”—and—“By what criteria should they be made?” In a single-payer health system, the government does the rationing. Government boards, panels, and regulatory bodies decide which patients will receive priority spending. In a pure free-market system, the rationing is done by the market, based on whether someone can afford the care they need or want.

Currently, in the United States, we have evolved a complex economic and financial apparatus to handle this fundamental problem of health care. This system, which certainly has downsides, does have its benefits, mainly that (a) no individual is forced to solely bear the cost of their care; and (b) no single organization has total control over the market. It’s an interaction between insurance companies, government agencies, hospital systems, and vendors (such as pharmaceutical companies).

This discussion, however, makes many people uncomfortable, because the idea of telling someone who is sick, “No, you can’t have that care,” is distasteful and uncomfortable. The priorities of the society and the individual are often not the same. As an individual, my life has infinite worth, and I would be willing to spend any amount of resources to preserve or extend it. To society, however, my life has finite worth, and society is not willing to spend unlimited resources on my health care.

This friction between society and the individual is at the heart of our society and is nowhere better embodied than in the health care debate. An ideal policy should balance the interests of the individual and the collective, with clear boundaries to which everyone understands and agrees. The only way we can reach that balance is a frank and honest discussion of the realities involved. Using emotionally charged terms like “death panels” doesn’t help, but neither does pretending that any one policy is a panacea which will provide all things to all people.

[1] Gilead priced Sovaldi at $1000 per 400 mg pill, which as part of a 12-week treatment course costs $84,000 and as part of a 24 week, treatment course costs $186,000. Sovaldi is most commonly prescribed as part of a treatment plan including other drugs such as Peginterferon-alfa, or Simeprevir (Olysio) which cost, $9,250, and $66,360 per treatment course respectively. When the price of Sovaldi is considered alongside the costs of medicines it is prescribed with, the aggregate treatment cost will often exceed $100,000 per patient.

Note: This was originally published by Wine With Cheetos on March 25th 2017 under the title “The Unavoidable Realities of Health Care”

Original Link: https://winewithcheetos.com/2017/03/25/health-care/

Lies, Damn Lies, and Statistics: Refugees and Terrorism

When President Trump issued his executive order on immigration, it reignited the issue of Syrian refugees, and the popular statistic “you only have a one in 3.64 billion chance of being killed by a refugee”[1] began circulating widely on social media.

This statistic, while factually correct, is severely misleading when used out of context. Advocating using it as a driving force behind public policy grossly misunderstands both probability and how probability is used in security policy.

It is important to look at this in its wider context: “you have a one in 3.64 billion chance of being killed by a refugee.” There is a significantly higher chance that any given refugee is a terrorist (one in 162,625). These are reached by calculating together that out of 3,252,493 refugees admitted to the US, 20 were terrorists. Between those 20, they succeeded in killing three Americans. The total deaths were divided by America’s population since 1975 to reach one in 3.64 billion[2].

It is misleading to rely on historical data alone for determining the probability of a future event. FEMA training and guidance warns directly against this practice.

“Communities should take care to not over-rely on historical averages or patterns that may give a false sense of likelihood,”[3] the Department of Homeland Security warns.

Historical data is remarkably bad at predicting the future, especially aberrations like terrorist attacks. Prior to 9/11, the “likelihood” that 19 foreigners would be able to destroy the World Trade Center and directly attack the Pentagon would have been effectively zero. It happened nonetheless.

Estimating probability (or likelihood) is also only one part of the process for determining risk and creating policy. Other values are weighed, including consequence and vulnerability. If something is highly unlikely but would have a catastrophic consequence, then it’s assigned a high-risk value despite being very unlikely.

The part of the discussion that always gets glossed over is that there is a risk inherent in the refugee system (or letting any foreign nationals into the country for that matter), and there always will be. We know that terrorist organizations are attempting to embed their members in refugee and migrant groups to get them across western borders[4]. No amount of extreme vetting as the President advocates will eliminate that risk, better processes can decrease it, but not eliminate it.

The conversation Americans should be having is how much risk is acceptable. Policy and law are not made in a vacuum. Homeland security wonks are not appointed philosopher kings, allowed to create national policy at will because there are other things Americans value alongside safety and security.

Americans need to have a continuing national conversation about those values, and about how much risk we’re willing to tolerate towards humanitarian ends. Using statistics like “one in 3.64 billion” as “empirical” proof that refugees pose little risk to Americans is misleading and a tool for shutting down the conversation. It serves no purpose other than leaving the brandisher of the statistic self-satisfied in their own intelligence, and the person on the receiving end silently indignant having not changed their mind. Ideally, leadership would come from our elected representatives on honest discussions of national values and acceptable risk- but it doesn’t seem likely that that will happen.

[1] http://www.politifact.com/california/statements/2017/feb/01/ted-lieu/odds-youll-be-killed-terror-attack-america-refugee/
[2] https://www.cato.org/publications/policy-analysis/terrorism-immigration-risk-analysis
[3] https://www.fema.gov/media-library-data/8ca0a9e54dc8b037a55b402b2a269e94/CPG201_htirag_2nd_edition.pdf
[4] https://www.washingtontimes.com/news/2017/jan/29/isis-finds-success-infiltrating-terrorists-into-re/

Note: This was originally published by Red Alert Politics on March 3rd 2017 under the title “1-in-3.64 billion chance of being killed by a refugee? Believe that at your own risk”

Original Link: http://redalertpolitics.com/2017/03/03/1-3-64-billion-chance-killed-refugee-believe-risk/