Professor Yeti » Blog Archive » Feeling Better Until the Bill Arrives

Feeling Better Until the Bill Arrives

To those who take Remicade, it is, seemingly, a magic elixir of life. For many individuals suffering the often-debilitating effects of Crohn’s disease and rheumatoid arthritis, life can be effectively divided into two phases: Before Remicade, when each day, if not each movement, was a painful struggle, and After Remicade, when, as many put it, they “got their lives back.” I’ve spoken to many people who have Crohn’s, an inflammatory bowel disease, as well as some who have rheumatoid arthritis, and all of those who have tried Remicade have had the same reaction: it is a miracle drug.

But miracles don’t come cheap. Remicade’s price has come down considerably since it was first approved by the FDA in 2000, but the current market price is about $650 per vial, with two to three vials needed per dose (the precise dose is determined by the patient’s weight). For most patients, then, Remicade costs between $12,000 and $15,000 per year – an extraordinary amount of money, especially considering that health costs for those with Crohn’s and rheumatoid arthritis are already fairly high, given the myriad other drugs, regular lab tests to monitor health, and frequent visits to specialist doctors.

$15,000 every year to be able to fully function. That’s the reality for those dependent on Remicade. Money can’t buy happiness, to be sure, but if it can buy a modicum of normalcy and provide relief from constant pain, who among us would not do everything we could, short of living in abject poverty, to continue to receive this medicine? Those with health insurance (or considerable personal wealth) don’t need to worry too much about this question. But this is a country in which one in seven people has no medical coverage at all, and one in three of those under 65 will lose coverage within the next two years – the hope and health that comes with Remicade is not accessible to everyone.

Remicade is just one of many prescription drugs with the same basic factors at play: extremely effective, but incredibly expensive, because they benefit a relatively small subset of the population. Among the others are Enbrel, another drug used to treat rheumatoid arthritis; Avonex, for the treatment of multiple sclerosis; Epogen, for those with HIV; and Rituxan, a non-Hodgkin’s B-cell lymphoma drug. Each of these drugs is classified by the FDA as an “orphan drug,” one that treats a disease affecting fewer than 200,000 Americans.

Before 1983, there were few orphan drugs simply because there was not the financial incentive for companies to develop such drugs (due to the small markets). And, indeed, between 1973 and 1983, fewer than a dozen drugs for rare diseases were developed. But in 1983, Congress passed the Orphan Drug Act to provide various inducements to spur research and innovation with regard to orphan drugs – namely, the first developers of such drugs received seven years of market exclusivity, which can be overturned only if another drug is proven to offer improved safety, convenience or efficacy.

The result has been a boon for the creation of new life-saving and life-enhancing drugs – since the passage of the Orphan Drug Act, more than 220 drugs for rare diseases have been approved by the FDA, with hundreds more in testing. The effect of these new incentives is clear. But what’s the cost?

The market for orphan drugs is inherently limited, and even after the seven-year period of exclusivity, there is little incentive for pharmaceutical companies to compete against each other to make different versions or for companies to manufacture low-priced generic versions. The original manufacturer doesn’t make enough of the drug to be able to offer the lower prices of large-scale production. And the customer base is fairly stable – unlike, say, erectile dysfunction, from which television commercials seem to claim that every American male will eventually suffer (and probably already does), rare diseases are inherently rare. There will never be a Cialis or Levitra to Remicade’s Viagra – there’s not enough of a market (and frankly, problems of the colon and the joints just don’t have the same effect on the twenty-first century American psyche as erectile dysfunction).

This is not to say that there’s no money in orphan drugs – worldwide sales are of such medicines are expected to top $43 billion by 2008, and Remicade alone had sales of over $1 billion worldwide in 2003, as did a handful of other orphan drugs.

But in a country where health care is not universal, and where pharmaceutical companies and HMOs wield the ultimate power – rather than the doctors or, heaven forfend, the patients – those impressive numbers don’t necessarily signal the product’s success. Shareholders may measure a drug company’s status by looking at the profit margins, but when it comes to health care, shouldn’t the bottom line, as measured by society at large, be that drugs are successful when they realize the maximum benefits to the maximum number of people they can help?

Encouraging innovation is admirable, but what about making people healthy? The saga of orphan drugs seems to be but a symptom of an inherently flawed health care system. Make that systems, plural – in the United States, there are many systems, many networks, encompassing many, but not all, people. If you have the right access to the right people, you have a better chance of seeing the right specialist who will make the right diagnosis of your problem. Part of the treatment may be a prescription, which, for many people, may be an orphan drug. But what if you don’t have insurance? You may be able to afford to see the specialist – you may feel that your health takes precedence over, say, your desire to vacation in Aruba or buy a new computer. It’s comparatively easy to undertake this one-time cost. But treatment, especially for a chronic disease (such as Crohn’s or rheumatoid arthritis), is a much longer-term commitment.

And the question is, Will your doctor’s treatment plan depend on your insurance status? It’s easy, even imperative, for a medical professional to prescribe immediately life-saving procedures or prescriptions. It’s also easy to prescribe drugs that are life-enhancing but not innately live-saving (or life-prolonging) if the patient has health insurance – with the knowledge that someone else is footing nearly all of the bill, and the patient will be out a co-pay of $15 per dose, rather than the market value of nearly $2,000, it’s not a difficult call for the doctor to make.

Clearly, drug manufacturers should be encouraged to research all medicines for all conditions, and they deserve rich compensation for creating new drugs that, like Remicade, make the difference for patients between merely being alive and truly living. But shouldn’t the dissemination of these drugs be equally important? Shouldn’t the real goal be not just to help the drug companies, but to help the patients, particularly those with rare diseases, for which treatment options are already narrow and generally not as well-researched as better-known afflictions? These are the people who are most in need of a glimmer of hope, and when it is offered, in the form of an orphan drug, it seems distinctly cruel to withhold it from certain people because they happen not to have insurance or large sums of money just sitting around. That’s the central problem with orphan drugs: when the incentives are limited to the research side, as opposed to the distribution side, the end result is a lot of great medicine that isn’t getting to everyone who needs it.

Doug Mack (doug@professoryeti.com) would like to take this opportunity to offer some full disclosure: he has Crohn’s and is a happy recipient of Remicade (luckily, he has health insurance … for now).

This entry was posted on Sunday, April 3rd, 2005 at 8:49 pm and is filed under Features. You can follow any responses to this entry through the RSS 2.0 feed. Responses are currently closed, but you can trackback from your own site.

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