Drug Shortages Reveal the Free Market is Failing Our Sickest Patients

**Update, the NYT has an editorial in their Sunday edition recommending the passage of two bills in congress requiring advanced notice from drug manufacturers in event of likely shortage.

i-1ae05c713060a45402a652d348e56148-pngHealth affairs discusses the increasingly frequent shortages of critical, life-saving, generic drugs. This is a serious problem that seems mostly limited to the U.S. healthcare system, and may adversely affect you or someone you know.

Many of the same drugs are not in such short and unpredictable supply in Europe, where in some cases they carry higher prices. This provides one major clue to the root cause: It’s the money.

Three of every four drugs on the US government’s shortage list were sterile injectable drugs, according to a report by HHS. For the most part, these are relatively low-cost generics. Simply put, most of those drugs are not very profitable to produce and sell, or supplies of them would not have dried up.

At an online presentation for journalists in November, Valerie Jensen, associate director of the FDA’s Drug Shortage Program, provided a casebook example. She mentioned the price of the tried-and-true sedative propofol, a lethal dose of which was found to have caused the death of singer Michael Jackson: The cost is forty-eight cents for a twenty-milliliter vial. “The older, sterile injectables are not economically attractive” for manufacturers to produce and market, Jensen said. Other generic drugs can have higher profit margins.

Propofol, one of the most frequently used drugs by anesthesiologists, is in increasingly short supply. I get emails from my hospital about which drugs are in short supply as physicians then try to ration these drugs for the most critical cases. In my own experience in the last year I’ve seen shortages of everything from injectable calcium gluconate (for electrolyte deficits), to levophed (a life-saving pressor used in critical care), metoclopramide (anti-nausea), and fentanyl (a powerful and useful short-acting narcotic). The FDA has a full list of recent shortages and it’s scary. Parents are having trouble finding drugs for their kids’ ADHD, vital chemotherapeutics like daunorubicin and doxorubicin are in short supply, dexamethasone (a powerful steroid), valium, digoxin (a staple of congestive heart failure and anti-arrhythmic treatment), diltiazem (hypertension and anti-arrhythmic), phenytoin (anti-epileptic also often used in acute brain injury), furosemide (an ubiquitous diuretic), haloperidol (anti-psychotic and sedative), isoniazid (a antibiotic used in TB), ketorolac (an excellent anti-inflammatory and analgesic), levofloxacin (a quinalone broad spectrum antibiotic), methotrexate (immune modulator), midazolam (a great short acting sedative), naltrexone (for reversing opioid overdose), vasopressin (another pressor) all are in short supply.

The drugs affected span all classes, what they have in common is they are all generic. Since there is too much competition in generics and too little profit margin, drug companies do not have a financial incentive to maintain adequate stocks to keep the drugs cheap and available. Shortages, if anything, increase profits because then the prices become artificially inflated.

Manufacturers, not surprisingly, blame the FDA, however the FDA hasn’t changed its standards despite increasing problems with shortages due to contamination or impurity. And that’s just for manufacturers in this country, fully 80% of the medications are produced, or active ingredients are produced, abroad. The main problem seems to be a concentration of production to a handful of companies that have adequate production capacity to compete in the generic market:

There is also a high level of concentration in US manufacturing for such drugs. That leaves little redundancy in the market as there would be for, say, generic statins. Three companies in particular–Hospira, Teva, and the Bedford Laboratories division of Boehringer Ingelheim–have been involved in selling 71 percent of the sterile injectable market by volume, the government says.7 All three have had manufacturing problems in the past two years.

With such consolidation as well as tight inventory management practices, the specialized manufacturers of injectable drugs lack the flexibility to adapt to manufacturing disruptions. If one plant shuts down, it may overburden the limited remaining competitors or choke off the supply entirely.

It’s hard to estimate the effects of these shortages, I don’t have good data on the damage done nationwide, only my personal experience. In particular, I remember during an ICU rotation running out of levophed, an incredibly important pressor that helps patients who are in shock from becoming fatally hypotensive.

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How Do you Want to Die?

Via Zite I found the article How Doctors Die by Ken Murray and was surprised to find it one of the best I’ve read on the issue of end-of-life care. The context is that of how Doctors typically forgo extreme measures in the face of terminal diagnoses, and often reject the type of care we routinely provide to our patients as “not for us”. While the article lacks hard data on the prevalence of these attitudes or behaviors, I have to say this viewpoint is consistent my experience of learning my colleague’s beliefs and how I now personally feel about ICU care . And I’m someone who is interested in trauma and critical care as a career…

Years ago, Charlie, a highly respected orthopedist and a mentor of mine, found a lump in his stomach. He had a surgeon explore the area, and the diagnosis was pancreatic cancer. This surgeon was one of the best in the country. He had even invented a new procedure for this exact cancer that could triple a patient’s five-year-survival odds–from 5 percent to 15 percent–albeit with a poor quality of life. Charlie was uninterested. He went home the next day, closed his practice, and never set foot in a hospital again. He focused on spending time with family and feeling as good as possible. Several months later, he died at home. He got no chemotherapy, radiation, or surgical treatment. Medicare didn’t spend much on him.

It’s not a frequent topic of discussion, but doctors die, too. And they don’t die like the rest of us. What’s unusual about them is not how much treatment they get compared to most Americans, but how little. For all the time they spend fending off the deaths of others, they tend to be fairly serene when faced with death themselves. They know exactly what is going to happen, they know the choices, and they generally have access to any sort of medical care they could want. But they go gently.

Significantly, Murray discusses what “doing everything” can mean. Sadly, most people equate caring for their family member with asking for maximum care when they are sick or dying, but doctors know, and poorly communicate, that maximal care is often painful, expensive, and too often futile.

Almost all medical professionals have seen what we call “futile care” being performed on people. That’s when doctors bring the cutting edge of technology to bear on a grievously ill person near the end of life. The patient will get cut open, perforated with tubes, hooked up to machines, and assaulted with drugs. All of this occurs in the Intensive Care Unit at a cost of tens of thousands of dollars a day. What it buys is misery we would not inflict on a terrorist. I cannot count the number of times fellow physicians have told me, in words that vary only slightly, “Promise me if you find me like this that you’ll kill me.” They mean it. Some medical personnel wear medallions stamped “NO CODE” to tell physicians not to perform CPR on them. I have even seen it as a tattoo.

To administer medical care that makes people suffer is anguishing. Physicians are trained to gather information without revealing any of their own feelings, but in private, among fellow doctors, they’ll vent. “How can anyone do that to their family members?” they’ll ask. I suspect it’s one reason physicians have higher rates of alcohol abuse and depression than professionals in most other fields. I know it’s one reason I stopped participating in hospital care for the last 10 years of my practice.

This situation of futile care is sometimes referenced with some some gallows humor as the chee chee. Why are we unable to communicate to patients that often the treatments that we can provide aren’t something we’d chose for ourselves or for those we love?
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Why no one should take Nexium and it should never have been approved

As Chris discussed Saturday the WSJ had a silly article in which a woman demands a prescription drug from a flight attendant, asking for the wrong drug to treat her problem acutely, and then shockingly was refused this service. Worse, Nexium is mentioned by name, multiple times, and Nexium is actually a drug which should never have even been approved by the FDA. It really is only prescribed because of intense marketing because, logically, it has no business on the market and is no different than an existing drug, prilosec. Why would doctors irrationally prescribe this drug then? Because advertising encourages irrational choices.

So why is Nexium such a scam? Read below the fold.
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Don’t mess with your neck doing yoga either

For some reason the NYT is all about neck injury lately. In yesterday’s discussion of a possible chiropractic induced injury, Russell asked:

But given all the other stresses people put on their necks, from accidents such as headbumps, from purposeful athletics such as whacking soccer balls, and from just craning one’s head in odd positions when performing various kinds of mechanical labor, it puzzles me that the risk from a chiropractor would be much greater than the risks from these other kinds of use/abuse. Of course, this is not excuse for the chiropractor, who is imposing that risk, likely on those more susceptible to injury, under false pretense or treating disease. It’s more a general lament that we each carry so much haphazard anatomy.

Interesting he should mention this as today the NYT has an article How Yoga Can Wreck Your Body describing many ways that neck hyperextension during this popular exercise can also create similar injuries to the vertebral and carotid arteries.

The mechanism is similar…
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Think like a doctor, don’t let them crack your neck!

This week’s think like a doctor column in the NYT is great. It asks the question, if a woman goes to a chiropractor, gets her neck manipulated, and within hours and for the succeeding four years she’s had symptoms of severe headaches and a pulsatile sound in her ears, what is the diagnosis?

You can guess what mine is…
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What should a national health care system look like?

I was pleased to see president Obama deliver this address yesterday:

I was even more pleased because he has gathered the traditional opponents of healthcare reform around him and has convinced them to commit to reform in the US system. This is a positive sign. However, I’m concerned because, as with all political debates that challenge a dominant ideology – in this case free-market fundamentalism – we will soon see the denialists come out of the woodwork to disparage any attempt at achieving reforms that may result in universal health care coverage. This has, in fact, already begun, and typical of the tactics they selectively mention the British NHS. If you care to read a balanced article on the history and function of the NHS, you’ll probably agree it is wrongly demonized. What you will also see is that the denialists will ignore a few key facts which include:

1. The United States is the last industrialized nation that lacks a universal healthcare system. Once again, thanks to obstructive policies led by the free market fundamentalists, the US is trailing the rest of the world.
2. The US spends more per capita on healthcare than any other nation in the world.
3. Despite spending more, we get less. We have tens of millions who are uncovered – which does not mean they do not receive healthcare at all. They instead are treated in ERs, urgent care centers, or receive substandard care, and the state ends up picking up the bill anyway. So even without a planned universal health care system, you end up picking up the (higher) bill because the state has a vested interest in protecting hospitals from the economic collapse that would occur if they had to pick up the tab on every impoverished patient who doctors are ethically and legally obligated to treat.
4. Many national healthcare systems work. We will not hear about this from the ideologues who will soon harangue us with cherry-picked horror stories of long wait times and underfunded hospitals. You will likely not hear about Sweden or Italy or France, and I promise you will never hear them talk about Australia. For them to do so would be to admit to defeat of their fundamental premise that universal health care can not work.
5. Failures of national health systems are not related to universality but instead are due to chronic underfunding by government. If the British spent as much per capita as we did, they wouldn’t have the shortfalls in manpower and beds that they do.

We will of course hear a lot of chest thumping from the thick-browed morons about how the US is already perfect and can not learn anything from the rest of the world. We will hear how every other system in the world is imperfect, and that is why any reform is impossible. We will hear how this will lead to communism and socialism despite the fact that every other industrialized nation in the world has universal healthcare and amazingly they didn’t all go commy. In short, we are about to hear a bunch of denialist garbage designed to delay, to obstruct, to block, and drag down any meaningful action in healthcare.

But before that happens, let’s have a more balanced discussion on what a universal healthcare system could look like in the US.

Any discussion of changes in the US medical system must begin with a statement of principles guiding reforms in the system. Let’s start with some of the principles I would include, and I think most of us could agree on:
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Rating your doctor online – is this a good idea?

I have just finished taking my last major exam of medical school – Step 2 of the boards (including Step 2 Clinical Skills, or CS, which costs 1200 bucks, requires you to travel to one of a few cities in the country hosting it, and is sealed by a EULA that forbids me from talking about what the test was like), and am winding down my medschool career in the next few weeks. It’s about 2 weeks from Match Day (the 19th), when I’ll find out for sure where I will spend the next 5 or so years of my life. I’ll be sure to have a post up a little after noon that day when I find out what the answer is. And then, around May 17th, graduation day, I’ll be a medical doctor, ready to start internship (also known as the hardest year of your life).

One of the things I’ve found universal to all medical students is that we really want to be good doctors when we are finished with our training. I don’t think I’ve ever met a medical student who was in this career for the money (you’d be crazy), or for other selfish reasons. They tend to be hard working, dedicated, humble people who, if anything, are sickeningly sincere about wanting to help other people. Maybe that’s just my school, but my experience is, these folks want to do good in the world.

But another universal is that not all doctors will be able to avoid making mistakes. Doctors are human, they all will eventually make errors, and the goal of any profession dedicated to improving the human condition should be constant self-reflection and efforts at self-improvement. This is not a simple thing to do however. Medicine is complex, and quality of medical treatment is very difficult to assess. We’ve discussed before, using metrics in medicine is challenging, and often rather than studying medical quality you end up merely assessing the social demographics of the physicians’ patients.

So it is with interest that I see reading boingboing that lots of people are upset because some doctors are forcing their patients not to rate them on sites like RateMD.com by having them sign a contract forbidding them from doing so.

The arguments for and against this practice are fascinating. We tread into the mucky waters of free speech, free enterprise, the practice of medicine, and the practical problem of assessing physician quality…

More below the fold…
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Nerds once again in control of government

And I breathe a sigh of relief. Working nights my schedule is a tad goofy, but I wake up today to see this guy describing the changes in the new budget:


This is Peter Orszag the new director of the Office of Management and Budget. He is a nerd and I instantly like him. I was not surprised to find he used to be a blogger.

It was especially refreshing because for too long our government has been run by this guy:

In particular I agree with their emphasis on health care as a necessary element for creating a viable modern economy. America has to compete with other countries that provide this for their workers, and we have a system that regularly ruins the finances of our citizens. I also agree with it as a moral necessity. Within the last week I’ve admitted several people for whom a hospitalization would result in significant financial stress. I talk about it with them, and they’re terrified. On the one hand, they need help. Sometimes their life depends on it. On the other hand, if they lack insurance a hospitalization can bankrupt them, and they’ll honestly admit, they avoided doing anything about their problems until they become life-threateningly severe because they are they can’t afford the help. This isn’t just stupid system, but immoral.

Additionally the need for reform of redundancy and costs in medicine would be a welcome reform. While the privacy issues with the electronic medical record are significant (I’d love if Chris would comment on this), the obvious need for it is undeniable. I can’t tell you how many times tests, expensive tests, are repeated because of incompatible records systems, delays in record transfer, and, frankly, the fact it’s sometimes just easier to duplicate the test than do the scut to find the answer. The emphasis on evidence based medicine, an attack on redundancy, and improvements in coverage will go a long way towards decreasing the terrible costs to insurers and the government, and terrible financial harm medical care can do to our countrymen. I am excited about seeing how this will be implemented, and relieved that once again we have people in charge who use words like “data” and “evidence” and seem that if there are problems generated by these reforms, they will be receptive to criticism.

Choosing a Medical Specialty IV — Interviews!

The process of choosing a medical specialty, and applying for residency programs is nearly complete as I have returned from my tour of the West Coast and am nearly done with interview season. This is when medical students travel the country at great (and unreimbursed) expense to find their future training program. When all is said and done, all your research into programs and time spent interviewing boils down to a simple question. Do you want to work with these people for the next 3-7 years of your life?

It’s also nice to see the cities where you may live and get a feel for the type of lifestyle you may enjoy. You also get to take pictures from helipads! Like this one from UNC:


And then there is the famous medical art like the Gross Clinic at Penn which also graces a common surgery text:


Or Ether Day (in the Ether Dome at MGH):

i-e7a15501c4bbbbd3b269b763122e6cde-ether day.jpg

More pictures and some fun interview questions below the fold…
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Smokers—what should we do with them?

We sometimes treat them like second-class citizens. Or do we? Certainly smokers hate it when we force them out into the cold for a butt. Here in Michigan, we’re thinking about restricting smoking in a lot of public places. There benefits are supposed to accrue to three groups: the smokers themselves, their co-workers who are exposed to second-hand smoke, and the public, who pays more for health care because of smoking.

I asked a simplistic question once about whether smokers should pay higher insurance premiums, that doesn’t really bring the same benefits to everyone as a more comprehensive approach. Now, outlawing smoking altogether seems foolish—you know, prohibition, black market, etc. But is it unreasonable to limit smoking to, essentially, the someones own private space?

How do we justify a potential limitation of individual liberties? Smoking is the biggest cause of premature (and preventable) death in the U.S., leading to about half-a-million deaths yearly. Data from 1998 showed smoking was responsible for about 76 billion dollars in health care expenditures, plus productivity loses of about 92 billion dollars per year. Smoking sickens and kills people, and costs are (very crappy) economy a lot of money. For both economic and public health reasons, we must make smoking cessation a paramount societal goal.

How do we do this?

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