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Jul 19 2011

Health care; we still live in the world

So as you may have deduced from yesterday’s marathon post, I am back from my trip. While I spent the first week in sunny and beautiful Amsterdam, I spent the second week in sunnier Toronto – my old home. This trip wasn’t all pleasure though; in fact, I was traveling for business. I don’t talk about this on the blog often, but I work as a health economist. Basically, health economics is a branch of research concerned with resource allocation and decision-making in health care. We look at alternative methods of health care delivery, technologies, programs, etc. and apply the scientific method to work out which options are worth the investment of time, energy, and (ultimately) money. The goal, at least for me, is to maintain the public health system so that it is viable in the long term.

The biggest problem with public provision of health care (or really, any kind of health care provision) is that there are a finite amount of resources available. At every turn, we are confronted by the fact that while costs of care are climbing steadily, the amount of money available to fund treatment can’t even come close to keeping up. At some point, while we’d like to see that everyone gets all the treatment she/he needs and would like, we have to draw a line.

Sometimes we get in our own way a little:

A B.C. woman with a rare, serious skin disease can’t understand why the province refuses to cover a one-time treatment that would likely put it into remission — but will pay for much more expensive treatment that only helps relieve her symptoms…

Dermatologist Gabriele Weichert wrote to PharmaCare, recommending a one-time treatment with Rituximab instead. The drug is approved for treatment of rheumatoid arthritis and other conditions, and Weichert said the drug has also shown much better results in treating pemphigus.

So here it seems there is a clear-cut case where government bureaucracy is getting in the way of medical decision-making. We’ve got a disease, a drug that treats it (at lower cost, no less), and a bloated, inefficient system that won’t cover the cost of the medication because it’s not on “the list”. Pretty shocking, right? Well, until we read this:

A spokesperson for PharmaCare told CBC News approval was denied because Health Canada has yet to approve Rituximab for treatment of pemphigus. Using it to treat that condition is considered “off-label”.

Rituximab is part of a class of drugs called ‘monoclonal antibodies’ that basically mimic the body’s own immune response to foreign proteins. When a strange substance (in immunology, called an “antigen”) enters the body, it is recognized by the white blood cells. They form a chemical impression of the proteins that make up the antigen and begin creating antibodies. Those antibodies coat the foreign protein, signalling other blood cells to envelop and destroy them. Sort of like adding bacon bits to an otherwise-unpalatable salad. Monoclonal antibody drugs do this, but for tumour cells (which are not recognized as ‘foreign’ because they come from the body’s own tissue).

As you might suspect, these drugs are typically used for cancer. Using rituximab for skin disease is indeed an ‘off-label’ usage, and those can be potentially disastrous. The kind of cowboy prescription involved in giving treatments for which efficacy is not established can have potentially fatal consequences, as we’ve seen in the furore around so-called ‘Liberation Therapy’ for multiple sclerosis. The problem here is that there is likely never going to be the kind of trial that we would consider sufficiently strong evidence to justify covering rituximab for use in this setting – the disease is just too rare.

So why not just give it anyway? It’s medicine, right? What possible harm could there be in prescribing it? Well… how about death?

Four people with rheumatoid arthritis have died after being treated with Rituxan, says the drug’s manufacturer, which has issued safety information about the medication in conjunction with Health Canada. None of the deaths caused by a severe infusion-related reaction occurred among Canadian patients, Hoffmann-La Roche Ltd. said in a release.

All drugs have potential adverse effects, and some of those effects might be fatal. Doctors know this, which is why they take such precaution with filling prescriptions (well… that’s debatable I suppose). Giving a medication for an indication that is unknown may result in a miraculous cure, but it might also kill the patient. Because of the vast divide in knowledge between the doctor and the patient, and the unique level of trust that characterizes that relationship, physicians must be extremely careful in the advice they give. When the stakes are high, patients will often leap at opportunities for cures without really understanding all of the variables involved.

This is the tightrope that the health care system must walk every day. If they adhere to the rules and regulations too strictly, they run the risk of undertreating patients, or promoting practices that are inefficient and ineffective. Relax the rules too much and they run the risk of seeing patients die from inappropriate or experimental treatment at the hands of well-intentioned but ultimately misguided care providers. There are horror stories on either side of this divide, which can be (and are) milked in order to shift policy and public opinion.

There is no perfect solution to this set of problems. Different countries employ a variety of different approaches to find a way to maximize patient autonomy whilst simultaneously protecting them from the consequences of their own ignorance. Whenever there are failures, they should be brought up and discussed. The key to any system is one that is not so intractably bound by regulation that it cannot respond to times of crisis (like in the treatment of pehphigus), but not so flexible as to undermine its own ability to safeguard its stakeholders.

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3 comments

  1. 1
    Erica Klein

    Insurance company approvals often lag behind the research. I used Rituxan for an off label purpose (ITP) and there had already been several peer reviewed studies in medical journals supporting this use. I’ve had over three years of remission. The treatments cost $10,000 each and I had a total of 6. My insurance company will save money in the long term but it was an expensive few years. I don’t know how my doctor got the approval but I’m so grateful that he did. I was and am well aware of the risks of Rituxan therapy as was my doctor. I agree we don’t want to be throwing serious drugs at random illnesses, but when there is strong evidence, and the wheels of the government turn slowly, and one is very sick….

  2. 2
    Crommunist

    I’m glad that you had a positive experience, and it sounds like your doctor is a dedicated healer. It sounds like there was already solid evidence, and in cases like that I think there should be some kind of flexibility in the system. Where I live, some drugs are available on a conditional basis, pending evidence of certain clinical markers. Maybe something like that could be built into the system – a single-use exemption.

    That being said, if your doctor had been slightly less scrupulous, and you had been slightly more gullible, it’s not inconceivable that you could have been given an inappropriate drug that would have done more harm than good. That’s what the protocols are for. There’s got to be a balance between patient safety and patient care.

    Thank you for sharing your experience.

  3. 3
    Beauzeaux

    In the US, it’s much easier for a doctor to prescribe a drug for an off-label diagnosis. Insurance companies are the bottleneck there.

    I agree that it’s a bit of a morass. I also agree that the vein-clearing-for-ms is totally unproven, studies need to be done, and Medicare shoudln’t cover it. But I truly don’t know what I’d do if I had MS that was rapidly removing my ability to function. Most likely I’d be on a plane to Italy or Copenhagen — in fact, I’m pretty sure of it.

    Life can be very different when you’re dying.

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