Welcome to a Work in Progress

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What a thrill to be launching this new contribution to the PLoS Blog Network. Thank you for visiting this page. It’s an honor to be here, and I hope to serve you well with thought-provoking posts.

Work in Progress will focus on the ethics and economics of drug development. There is so much to get to, and I hope to gather together the pieces of this giant and utterly compelling puzzle in a way that makes for a useful, current and engaging read. Some of the topics I hope to explore in the coming weeks and months include the incredible impact of so-called orphan drugs on the pharmaceutical industry and healthcare, the far-reaching phenomenon of overtreatment, the looming issue of cost in treatment decisions, the troubling truth of racial disparities in healthcare, the hospitals-are-businesses-too issue, the controversial value of needle and syringe exchange programs (okay, I know that stretches the focus of this blog, but it’s too important to ignore), and so so so much more. I am so grateful to have an opportunity to write about these matters on the PLoS website.

If it helps to know: I’m a freelance writer who’s contributed to Scientific American, Slate, the New York Times, Nature Medicine, Science, The Scientist, Ode, Psychology Today, and elsewhere. I was the founding managing editor of Clinical Advances in Hematology & Oncology and Gastroenterology & Hepatology, and have written for several prominent magazines for cancer patients, physicians, and industry professionals, including CURE, CR, and Oncology Business Review. If you’d like to read clips of my published articles, you can find them here.

And as for the question about why I want to write about the ethics and economics of drug development? Over the years, it’s an area that has fascinated me completely. The challenging issues, the grey areas, the quandaries and dilemmas, the high stakes … I love wrestling with them all (which, I am well aware, some might find odd). I think that perhaps it is because these issues cut to the heart of so many questions that are literally of life and death. That’s the spirit behind the name of this blog: clearly, medicine is a work in progress. But so, too, is our handling of its many repercussions.

So – when it comes to beginnings, I like to follow the philosophy of starting as you mean to go on. And here at Work in Progress, that is: with more questions than answers. Today, my questions are about two experimental drugs for hepatitis C, telaprevir and boceprevir. These agents – both protease inhibitors – have shown excellent efficacy (telaprevir reported HERE, boceprevir reported HERE) in treating patients with this often fatal virus and both are expected to be approved soon. But here’s the thing. Telaprevir will cost about $70,000 per treatment. Who is paying for that? Do people with HCV have private insurance?  I am making an educated guess (which I’m sure some will contest) that coverage will rely heavily on public dollars.

magic pills By e-magic, http://www.flickr.com/photos/emagic/59259529/These new drugs are truly groundbreaking. The current standard of care – a combination of pegylated interferon and ribavirin – doesn’t work for many people and is, to put it mildly, rough on the system. Telaprevir and boceprevir offer, for the first time ever, a curative therapy for people who might otherwise die of this disease. And with 170 million people worldwide (more here) chronically infected with HCV, that’s a lot of lives saved.

But how does it work when a drug company wants to create a drug that is going to be paid for largely by public healthcare funds? Does the manufacturer weigh the demographic into the go/no-go decision of whether to develop the drug? Should we all get alerted about new drugs entering the Medicare formulary (that is, the list of drugs covered by Medicare for any given ailment)? Why is a disease that is transmitted mainly through intravenous drug use (and, to a lesser extent, unsafe sex), and that occurs with such high prevalence among the homeless, for example, a “battleground” for drugmakers?  I’m not saying it shouldn’t be – I am asking what drives that battle, considering that pharmaceutical companies are, after all, businesses seeking to make money. As the New York Times reported, Citigroup analysts predict that telaprevir will rake in $3.5 billion per year by 2015 (albeit after many years of losses). Obviously, $70,000 per treatment costs a lot of less than a $350K+ liver transplant, a common option for late-stage HCV sufferers. But many more HCV patients are bound to come out of the woodwork to get tested for the disease knowing that these powerful treatments are available. (Right now, the disease often goes undetected until its later stages in part because potential sufferers don’t get tested and the disease itself tends not to show any early symptoms).

These questions are posed without judgment or cynicism about the pharmaceutical industry, and without any sense of castigation of HCV patients — it could be any of us. And obviously the considerations here are multi, multi, multi fold. But in terms of the mechanics of drug development and cost, the advent of these agents raises some interesting questions about the handling of cost and how profits are made.

In my next post, perhaps some work-in-progress answers.

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