Cancer care in the 21st century: “We must know how to suffer, grow old and die.” Bureaucrats across the globe are increasingly saying so.
| Nov 22, 2011
“I have come to the conclusion that each man must be his own doctor: that he must live by rule, now and again assist nature without forcing her: above all, that he must know how to suffer, grow old, and die” for “everyone has within him, from the first moment of his life, the cause of his death. We must live with the foe till he kills us.” -- Voltaire, 18th century writer, playwright and philosopher
While I am not a fan of Voltaire's writings, the chord of this passage has stuck with me over the years as I've been involved in healthcare my entire working life. What strikes me now, however, is how relevant this passage has become, with Voltaire’s depressing, defeatist tone increasingly being adopted by healthcare regulators around the world. How is that? Cancer and its treatment make a relevant example.
Many people consider a cancer diagnosis a death sentence. Due to advances in diagnosis and treatment, and depending on cancer type, that is less the case now than in years past, but it is still a diagnosis none of us wants to hear. Treatment advances continue, but at increasing cost, running in the tens to hundreds of thousands – in no small part due to increasing regulations governing research. How can such treatment cost be justified, especially when facing a terminal disease – in many cases with relatively near-term consequences?
Cost justification, or lack thereof, is the province of payers, increasingly governments or the bureaucracies that our governments have given rise to. For example, NICE, in the UK, ruled that Yervoy® (ipilimumab, Bristol-Myers Squibb) for metastatic melanoma did not warrant reimbursement approval based on its clinical profile, especially given its proposed price. And now the FDA has withdrawn approval of Avastin® (bevacizumab, Genentech) for use in breast cancer in the U.S. The typical bureaucratic justification for such decisions is that what patients and payers need is real innovation in treatment, not expensive incremental advances. But what defines real innovation in cancer treatment?
I contend that innovation is always incremental thus, real innovation is incremental. An oft repeated quote attributed to Sir Isaac Newton (but originating from others) reads: “If I have seen a little further it is by standing on the shoulders of giants”; so too incremental innovation in cancer therapeutics. Without building on the incremental success of others in cancer treatment and without standing on the shoulders of giants, where would we be today? Where will we be in the future?
Consider the frequently reported median overall survival outcome reported in clinical trials; they can easily sound unimpressive. For example, in a the most recent Yervoy melanoma trial, median overall survival was 11.2 months for the Yervoy-treated population versus 9.1 months for patients treated in the active control group; sounds unimpressive and very incremental, doesn’t it? Why pay large sums for that kind of result? But the findings also show that overall survival was substantially longer for quite a few patients on Yervoy: at one year (47.3% vs. 36.3%), two years (28.5% vs. 17.9%), and three years (20.8% vs. 12.2%). While we can’t at this point predict who will have such a response, if any of us were part of the improved survival group that would be significant to us, wouldn’t it?
And now the FDA has pulled Avastin’s indication in the U.S. for the treatment of breast cancer (even though it remains in Europe); this while knowing there is a group of unpredictable breast cancer super-responders to Avastin. So just because we can’t yet pre-identify responders or super-responders, the FDA has decided breast cancer sufferers shouldn’t be treated with Avastin even if they and their physicians believe it is worth the risk. Seriously?! Did cost play a role? That is not the charter of the FDA, but who really knows?
Physical death is, indeed, inevitable. Since that is an absolute, are we resigned to accept bureaucrats pushing us toward the extreme of Voltaire's view of life and death – a position that concludes that we must “know how to suffer, grow old and die." Where does that position begin and end? Is the value of life to become a mathematical formula decided by faceless bureaucrats? Or should we push those who serve us toward a better definition of assisting “nature without forcing her”?
If we are not prepared to demand access and pay today for super-response in some people, or if we aren’t prepared to pay and pay substantially for incremental improvement across the board, then we are less likely to see the major improvements in cancer treatment possible in the future. Cancer research will be dramatically reduced. Then, for the research that does continue, advances will simply cost that much more, which will raise the bar again, putting us in an unwinnable and unnecessary death spiral.
I say we must demand access to such drugs and be prepared to pay substantially as a global community for incremental improvement in cancer treatment in order to see cancer after cancer defeated in the future. If we do not, we are allowing regulators, bureaucrats, politicians and payers to deny us and future generations the advances that together we might have enabled, and in so doing fall to the extreme of Voltaire’s position.