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“I’m hearing more about getting more people covered,” he said. “I think they should do what they need to do to get elected, [but] . . . getting the costs down is the most important thing.” (Voters have big health worries…. Washington Post)

The concept of “the commons” is not an easy one for Americans to grasp. The concept of the commons originated in England. Sheep were (and are) owned by people but the grazing area was (and is) owned by the community. It was pointed out by William Lloyd that while there was an advantage to the individual to have a bigger herd (more money from wool), collectively the community would suffer as the land was overgrazed. Garret Hardin pointed out the problem of individuals acting in rational self-interest by claiming that if all members in a group used common resources for their own gain and with no regard for others, all resources would still eventually be depleted. Writing in the journal Science, he felt that relying on conscience as a means of policing commons was problematic as it favors selfish individuals – often known as free riders – over those who are more altruistic.

The median American spends under $300 on health related expenses in a given year. However, the average American spends $10,000.  How is this? It is because  5% of the population account for half of all health spending. The 5% of people who spend the most on health care spend an average of around $50,000 annually; people in the top 1% have average spending of over $109,750.  Getting into the top 1% is kind of a random thing. You get bad cancer…you are there. You have a baby, you are not there but you move from $300 to $11,000 for that year. If you have the unfortunate luck of having your baby early…boom, your baby just hit $1,000,000.

So, in the The Affordable Care Act was designed, in part, to address the “free rider” problem in health care. Turns out almost everyone is willing to pay $300 for their healthcare every year. Almost nobody can pay over $100,000 when they randomly get cancer. What people are inclined to do is take advantage of the fact that other folks are paying into a system to support cancer care and then, when they get cancer, show up and  assume “it’ll get paid for.” The problem of the commons. The mandate was put in place to make us all pay for it to be there. Also, to make us all aware that the way we have it set up is very expensive and inefficient.

What we have made explicit through the Obamacare mandate is that the admission to the healthcare commons costs working families about $17,000 a year. On top of that about a third of our tax dollars are going into paying for the healthcare commons. Given the small amount Americans see themselves taking in a given year, it is no wonder they resented the mandate. On top of that, the value we receive is much less than what citizens of other countries get. On average they live longer, are healthier, and report fewer problems than Americans. They pay about half (or less) of what we do as well.

In the analogy of healthcare as a commons, who is getting rich?  Unlike sheep, sick Americans are not left to graze alone. Although there are now “free riders” because the mandate has been removed, this is only a small part of the problem. Turns out that our “grazing” is directed by doctors and hospitals motivated by the profit motive (with no price transparency), pharmaceutical companies advertising high cost medications directly to the consumer (with no price transparency) and people with limited health literacy who are making decisions based on fear, misinformation, and who are given guidance by folks who profit from the consumers ignorance. Other aspects of Obamacare, designed to fix these problem, are either not being implemented or being held in check by powerful interests (doctors, hospitals, pharmaceutical companies).

Which brings us to the the tragedy of the healthcare commons. We as a country are about to enter into a time where we spend more on healthcare than the average person makes. In England, to this day, there are all sorts of rules about who can use the common land and how many ducks, sheep, and the like he or she may put on the land. In America, we declare where our cows are to be a “sovereign state” and shoot at those who try to enforce the rules of the commons. One Republican Senator said of the  folks engaged in rule-breaking, “These people are patriots.”

We thought the individual mandate addressed free-riders. The reality is that the person with no health insurance who gets in a car crash or gets bad cancer is only part of the problem. The real “free riders” are those who profit but have no responsibility for the upkeep of the commons. The controls needed are not to keep people from consuming healthcare. The real need is for controls on those who would profit from folks who are scared, hurt, and confused about how to use a broken system. There are many ways for these controls to be put into place. The question is do we have the strength as a country to enforce such controls or do we declare those folks who profit at the expense of all of us patriots?

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Me: Why is your blood sugar so high?

Patient: Couldn’t afford the insulin

Me: But you have insurance and it is on your insurances formulary. I thought you told me it cost you $30 a vial

Patient: Yeah, this time it costs me $150. And ya know, I gotta eat….

A couple of years ago I was fixated for a while on the cost of insulin. Mostly, I fixated on why it was so expensive. From 2012 to 2016 the price of insulin doubled and to have Type 1 Diabetes meant someone (the patient, the insurance company, the government) had to pay on average $18,500 a year. In other words, without insurance they have to budget to buy a new car every year, with no trade-in.

Having Type 1 Diabetes is basically like having a birth defect. The prospective patient is at risk to losing the ability to manufacture insulin from birth with exposure to a certain virus being the trigger for this to actually occur. The only treatment for folks who acquire Type 1 Diabetes is insulin replacement therapy. Without it, they die. Well, we are pretty sure they do. Since insulin was discovered in the 1920s it has been unethical to withhold insulin as a medical experiment from Type 1 diabetics. Prior to that, by literally starving the patient to death, you could buy them up to a year. Since the 1920s, we have had insulin. The discoverers sold the patent for a dollar a piece so that humanity could benefit.

Type 1 diabetes is a great disease (as diseases go) for a doctor to treat. The body has a deficiency. Replacement is relatively straightforward. If the patient is cooperative with regime (checks blood sugar regularly, administers insulin to keep sugar down) he or she can expect to live into their 8th decade. The dad of my best friend growing up was a Type 1 diabetic and he survived his into his 70s with diabetes only to die in Katrina. Though special diets may help and exercise may help, what is required is insulin. Without it, ingested sugars and fats convert to ketoacids instead of energy for the body and then death happens. Almost always when someone with Type 1 diabetes has ketoacids in their blood they are either insulin deficient (“well, doc, I meant to take my insulin this morning but…”) or have another illness that has increased their insulin requirements.

Which brings us to the cost of insulin. The prices, it seems, keep going up. For us non-diabetics it would be like charging us for air. Not only that, but charging us extra after exercise for the extra oxygen we extract. Why is it going up? To find out I spent a lot of time reading about our really crappy system of pharmacy distribution and payment systems. Remember the corner pharmacist? Now he is a pharmacy benefits manager. They control the prices the pharmacies have to pay for drug prior to distribution and control what the patient pays (the money they make off of this is called “the spread.” They make drug companies give rebates to get medications on the formulary that they rarely share with patients. They overcharge patients for medications and pocket the difference. They make pharmacists sign contracts that forbid them to tell the patient that the $40 lisinopril prescription is available for $4 at Walmart. They make consumers use coupons to artificially inflate the prices even more.

As much as I wanted to blame this new middleperson arrangement for the rising prices (and it can be blamed for the fluctuating prices), PBMs are not the cause. The insurers try to convince us that it isn’t them but a lack of personal responsibility. Drug companies try to say that cutting edge medicines are expensive and Americans deserve only the best.  Neither of these are true. As was reported in Vox:

Luo, the paper’s lead author, doesn’t find the “cost of innovation” argument very convincing. In his research, he’s come across many examples of the same insulin products that have been continuously available for years without improvements, and yet their price tags have gone up at a much higher rate than inflation.

“The list price of these products are already out of reach for most Americans living with diabetes — in some cases over $300 a vial,” he said. “It is also strange to see Humulin still priced at over $150 a vial considering this product was first sold in the US in 1982.”

In other words, drug companies are flat out raising prices. Why are they are doing it? Because they can. There are only 3 companies that make insulin, the products are not generic (small improvements patented every 10 years to keep a new patent), and oddly the prices are the same across all the companies.

So what can we do to stop it? As a physician, there are a couple of things I can do. There are “human” insulins that is relatively cheap (NPH and Regular, alone and in combination) that I can write for my Type 2 diabetic patients. In theory this would, over time, drive the price down if we all did it. I can (and do) only use formulary medications whenever possible, even though it means switching several times a year at times. As a patient, consider using cheaper “human” insulin if you have Type 2 diabetes. Talk to your doctor about making the switch. Join in the protests over the cost of insulin. Let policymakers know that access to life sustaining hormones should be a right. To paraphrase Martin Niemoller, first they come for your hormones….

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Patient: I can’t afford the insulin you prescribed for me.

Me: It’s a pretty standard long acting insulin

Patient: My insurance says it’ll cost $350 a month to use it, is there something less expensive?

Insulin is a magic drug. Discovered in 1921, it was first administered to humans in 1922. Although there were a long line of discoveries that made the discovery possible, Drs. Banting and Best at the University of Toronto were the first to identify the source (the pancreas) and to extract insulin for use. Even more amazing, the University made the discovery “open source,” allowing the manufacture and distribution without royalty.

The discovery was not without its problems. Although human insulin was synthesized in the lab, it was difficult to make for many years. Insulin taken from cows and pigs was commonly used clinically. Unfortunately, in one of the Creator’s little jokes, these insulins vary from human insulin by a couple of amino acids. Not enough to make them unusable as extracted but enough so that over time the diabetic patient developed antibodies and was unable to use the insulin, leading to his or her premature death.

In 1982 Richard diMarche and Eli Lilly obtained a patent for human insulin made from recombinant DNA. Originally sold as Humalog, this was the first medication manufactured in this manner and it was a game changer. No longer were we putting a foreign body into people to lower their blood sugar temporarily. We were putting human insulin into people and keeping people alive longer and keeping people healthier.

Which brings us to today. Drug companies developed pens, different types of insulins, and different delivery methods. They have also jealously guarded their patents, preventing cheaper generics from being developed. To quote the New England Journal:

“But whether each incremental innovation is worth the price we pay, in a world where insulin remains unaffordable to many patients with diabetes, is less certain.”

Reasons used for the high cost might include the need to ship the medication in liquid form as well as the different delivery mechanisms. The bulk of the cost of the drug, however, is in R&D. These drugs have been developed for years and there are no more R&D costs. Their investment has been recouped. It is becoming clear that a major reason is good old-fashioned “profit taking”:

Between 2005 and 2015 the cost of a lispro vial went up 264 percent, while a vial of insulin glargine went up 348 percent, and a vial of NPH went up 364 percent. That’s a lot, but other insulins went up even more.

The cost of an aspart pen rose in this 10-year period by 389 percent. And the cost of a vial of U-500 regular insulin jumped a staggering 508 percent.,

 

So, in America in 2016 we have people choosing between insulin and food. People that weren’t having to do that in 2006. The speculation is that this profit taking is in advance of the loss of the patent as well as the lack of “blockbuster” drugs on the horizon. Perhaps generics will be developed soon.

What did I do for my patient? There is one type of intermediate acting insulin that is $27 a vial at Wal-mart. No special pen, has to take it twice a day. For now, it turns out that diabetes in now a two-tiered disease, easy for the rich to handle but increasingly difficult to manage if you are poor.

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Me: Ms G, you have atrial fibrilliation and a lot of other medical problems. That means that your heart can form blood clots that go to your brain It is REALLY important that you take the blood thinner the cardiologist put you on.

Ms G: I know but he gave me this Elliquis and I just can’t afford it. My Blue Cross charges me $140 a month for the medication and that’s just too much

Me: There are much cheaper alternatives. Warfarin, for example, can be used very safely and keep you from getting a stroke.

Ms G: He never even mentioned that to me. Can you talk to him?

When this happened this past week, I was a little irritated. Ms G is not the easiest patient to care for and now I was having to deal with a problem not of my making. After making several phone calls we switched the Elliquis ($275 a month, $140 out of pocket to my patient) to warfarin ($6.50 a month plus $24 in monitoring costs, less than $10 a month to my patient) and everybody left happy (and late). Eliquis and other expensive blood thinners offer only a marginal improvement over warfarin and they do it in a very expensive manner. They reduce of the risk of stroke over 3 years from 16 stokes per 1000 people treated with warfarin to 12 stokes for people taking the newer medications. Of those 1000 patients, an extra one (2 vs 3) on warfarin will have a major bleeding problem. While an advantage, my patient chose not to trade $1200 in food money to do this and instead made the decision on her own to triple her risk of stroke (10 strokes per 1000 annually in those untreated with atrial fibrillation and her other conditions) by not taking anything. My patient is now on warfarin and presumably much better protected from having a stroke. Why was my patient not offered the opportunity to make a choice between the new improved method OR the tried and true method?

May have had something to do with marketing. As was pointed out last night, Americans have an expensive ($330 billion) prescription drug habit. The habit not only pays for the pills (a very small part of the cost) but also the payments to doctors who do the “education” of their colleagues. In 2013 this education cost Americans $24 billion, with marketing accounting for more than research in 9 of 10 companies. In the words of John Oliver “Drug companies are like high school boyfriends: they are more interested in getting inside you than in being effective once they are there.” Bristol Meyer Squibb spent an estimated $20 million in 2013 to “educate” physicians regarding the advantages of Elliquis over warfarin in stroke prevention, with about $15 million going to physicians to extol its virtues to other physicians. I don’t know if that was the reason for the oversight. To be honest I suspect in my patient’s case it was mostly ignorance of my patient’s social situation by the cardiologist that caused my long day.

At least my patient didn’t die from an overzealous sales force. Every day, 46 people die of prescription narcotic overdoses in the US. In Alabama in 2012 there were 140 narcotic prescriptions written for every 100 people. We really don’t need folks selling doctors on selling more narcotics. However, in 2012 a potent narcotic (Fentanyl) was introduced in a sublingual spray to compete with others similar preparations (Fentora and Actiq). These medications typically have, as their very specific indication (the reason to give to a patient), cancer pain not responding to around the clock narcotics. Insys, the company that makes Subsys, spent an estimated $6 million to educate physicians about this drug in 2013. I have to admit, until I read the Propublica article, I had not heard of it. As I don’t treat many patients with intractable cancer pain, that did not particularly surprise me. They only spent $44 a meal to educate 5,000 physicians. They did pay for 775 educational events (paying a physician $2,500 to talk about the drug every time) and hired 189 consultant physicians at $2,370 each. I guess they had to get the word out. Problem is they were and are getting the word out to the wrong people. Less than 1% of the prescriptions were written by oncologists. The product was a high potency narcotic of which there were already others on the market (a “me too” drug):

The former sales employees said that while the company targeted some oncologists, it placed more focus on high prescribers of competing products like Actiq and Fentora, regardless of whether those doctors treated cancer patients. They also said they were trained to mention the restriction to cancer pain at the beginning of the sales pitch and then to move on to a more general discussion of “breakthrough pain” in the doctors’ other patients.

Not only did Insys not worry about its drug getting into the wrong hands, it kind of counted on it:

Comments from a Wall Street analyst underscore that view. “As Subsys grows more mature, we expect the number of experienced patients to grow,” Michael E. Faerm, an analyst for Wells Fargo, wrote last year in a note to investors. “As the experienced patients titrate higher, the average dose per prescription should increase.”

The company used physicians who had problems with the DEA as their speakers and unorthodox methods to motivate its sales force. A cursory review of the Opiophiile forum reveals that their product is a success, with many addicted individuals enjoying the convenience and simplicity of the medication, with some even ingeniously discovering they can use it intravenously…just like heroin. Also the boards attest to the effectiveness of the marketing strategy.

Shelley, my doctor recommended it to me pretty much as soon as it came out. He said that the company that makes them wanted him to be a representative for them or something like that.

No wonder sales have increased 400% in the most recent quarter over last year and people are bullish on Insys’s prospects. in fact, investors only got skittish when a physician in Michigan who accounted for 20% of the drug sales lost his license. Fortunately for investors, their “medical marijuana” product is about to come to market to broaden the Insys portfolio and the market cap is back up.

Don’t get me wrong, I am by no means anti-medication. In fact, only 30% of people who would benefit from warfarin or related blood thinners receive them in the correct dosage and we need to work to use this inexpensive drug more effectively. I would personally prefer to find a different way to get the Opiophile readers their fix (with entries such as “Fentenyl patch, shootable” I am concerned their might be a lot of misuse in that community). Most importantly, as a profession, let’s stop shilling for Wall Street. I’m sure they’ll do fine without us.

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