Last week we began a discussion of the new Medicare rules, which will greatly expand compensation for off-label use of chemotherapy. We conclude, with references, this week.

Political Implications

Obama, as everyone knows, came into office with a promise to reduce the cost of medical care. According to barackobama.com, he will lower health care costs in part by investing in prevention. He will promote public health by, among other things, investing in preventive services, including cancer screenings. But how does increasing the expenditure for unproven and expensive drugs fit into that overall plan? In 2007, Medicare already spent $2.4 billion on anticancer drugs. Should we feed increasing amounts of money into a system that has failed to prove - in the majority of cases - that it actually increases patients' longevity?

Might we not be better off with a system, such as Britain's National Institute for Health and Clinical Excellence (NICE), which looks critically at the actual effectiveness of various treatments before agreeing to pay for them? For instance, NICE recently recommended against approving Tarceva (erlotinib) for people who have locally advanced or metastatic non-small cell lung cancer, who cannot take docetaxel, and have already tried one chemotherapy regimen but it has not worked. They have also recommended against Tarceva for people who have already tried two chemotherapy regimens, including docetaxel, but they haven't worked (www.nice.org.uk). These are indeed tough decisions, but at the end of the day, aren't patients better served by knowing what really works or doesn't work in treatment? Doesn't this put unproven drug treatments on a par with unproven unconventional treatments?

According to the Times, the recent Medicare change - which was quietly put through in the waning months of the Bush administration - will almost certainly raise the federal drug bill, "while making it more difficult for the new administration to rein in spending on unproven medical treatments." So the question is this: What will President Obama do about it? We know he wants to lower health care costs. But is he ready to take on the combined forces the American Society for Clinical Oncology and Big Pharma? And what about the patient groups, some of which have been carefully cultivated for many years by these same vested interests? Won't some of them scream with displeasure if Medicare reduces funding for new (albeit unproven or ineffective) drugs? Can Obama stand up to this sort of pressure? It will be interesting to see. It will also be interesting to hear the opinions of his chief of staff, Rahm Emanuel, whose brother, Ezekiel J. Emanuel, MD, PhD, is a breast oncologist and chief of bioethics at the National Institutes of Health.

A spokesman for the Obama administration declined to comment on the new Medicare rules. But stay tuned.

--Ralph W. Moss, Ph.D.

References:

ASCO policy:
http://www.asco.org/ASCO/.../2009%20Policies%20for%20Exhibitors%20and%20Other%2

Abelson, Reed and Pollack, Andrew. Medicare Widens Drugs It Accepts for Cancer. The New York Times, Jan. 26, 2009.

Abelson, Reed. Drug Sales Bring Huge Profits, And Scrutiny, to Cancer Doctors. New York Times, January 26, 2003.

Abelson, Reed. Pay Method Said to Sway Drug Choices of Oncologists. New York Times, March 8, 2006.

Brownlee, Shannon. Feeding the Cancer Machine. New York Times, April 1, 2007.

On Ezekiel J. Emanuel, MD, PhD:
http://www.bioethics.nih.gov/people/emanuel-bio.shtml