A recent issue of the Journal of the National Cancer Institute has a very important article by Tito Fojo, an oncologist at the NCI Center for Cancer Research, and Christine Grady, an ethicist with the NIH Department of Bioethics. "How Much is Life Worth: Cetuximab, Non-Small Cell Lung Cancer, and the $440 Billion Question" calls for a fundamental change in research, the drug approval process, drug pricing, and clinical practice. The analysis and argument will be familiar to ethicists and policy wonks. What's especially important about the article is that Dr. Fojo speaks as a distinguished cancer researcher and addresses his recommendations to fellow oncologists.
Drs. Fojo and Grady don't flinch from using the "c" word - cost:
In some sense, every life is of infinite value, and we naturally avoid confronting the tension between not wanting to put a value on a life and having limited resources. But the spiraling cost of cancer care in particular makes this dilemma inescapable. We, the oncology community, cannot continue to ignore it.The main example in the article is Cetuximab (Erbitux). Erbitux adds 36 days of life for patients with non-small cell lung cancer, but also adds a number of significant side effects. Conveniently, the study that demonstrated the 36 day extension of survival did not include quality of life measures. At its present cost, adding an average of 36 days of life is the equivalent of $800,000 per non-quality adjusted year of life. Fojo and Grady argue that this is far too much cost for far too little benefit.
The authors urge oncologists to act as true professionals who consider wider societal concerns like the uninsured or the U.S. economy going down the tubes. They don't use the word "narcissistic," but their analysis suggests that a profession that considers only its own perspective is just that. They make six specific recommendations for practice and policy:
1. "Research studies that are powered to detect a survival advantage of 2 months or less should only test interventions that can be marketed at a cost of less that $20,000 for a course of treatment." Here they are using the standard of one quality adjusted year of life for patients treated with dialysis ($129,090) as their standard.
2. Drugs should be priced accordingly.
3. "Drugs shown to be active in one subset of patients should be advocated, approved, and prescribed for that subset only. The marginal benefit, if any, which may be achieved in other patients should not be an excuse to administer a therapy even if it is decided that there is nothing further to be done."
4. FDA approved indications should be strictly adhered to.
5. "The all too common practice of administering a new, marginally beneficial drug to a patient with advanced cancer should be strongly discouraged. In cases where there are no further treatment options, emphasis should be first on quality of life and then cost."
6. "For therapies with marginal benefits, toxic effects should receive greater scrutiny."
Having exposed the chemotherapeutic emperor's new clothes for what they are, Drs. Fojo and Grady conclude:
We must deal with the escalating price of cancer therapy now. If we allow a survival advantage of 1.2 months to be worth $80 000, and by extrapolation survival of 1 year to be valued at $800 000, we would need $440 billion annually — an amount nearly 100 times the budget of the National Cancer Institute — to extend by 1 year the life of the 550 000 Americans who die of cancer annually. And no one would be cured.Drs. Fojo and Grady have issued a courageous and compassionate challenge to their fellow medical professionals. It deserves wide attention!
The current situation cannot continue. We cannot ignore the cumulative costs of the tests and treatments we recommend and prescribe. As the agents of change, professional societies, including their academic and practicing oncologist members, must lead the way. The time to start is now.
(The article is not yet available without charge, but a summary and paid access to the full text are available here. For Dr. Fojo's web page see here.)