Wednesday, November 2, 2011

Earlier Warnings of Cancer Drug Shortages? Alarm Bells Should Have Sounded 50 Years Ago

Right now in the US, over 40 million people are 65 years of age or older. And today -- right now -- we cannot meet the cancer drug demands of this age group. We cannot meet the demand for the wave of very expensive, new branded medications because the cost of these agents prohibits use for many patients. We cannot meet the demand for much cheaper generic cancer medications because -- among other reasons, some of which I addressed in a previous post about generic oncology drug shortages -- manufacturers do not get the financial returns to remain committed to continued supply.

To try to begin to remedy generic drug shortages that have already delayed care for many patients -- indeed, may already have led to preventable deaths -- President Obama signed an executive order earlier this week, directing the Food and Drug Administration to take action to reduce prescription drug shortages. The order instructs the FDA to do three things: broaden reporting of potential shortages of certain prescription drugs; speed reviews of applications to begin or alter production of these drugs; and provide more information to the Justice Department about possible instances of collusion or price gouging.

But none of those actions will increase incentives for manufacturers to make adequate supplies of generic cancer therapies. And none of those things will alter the fact that by 2030, the number of people ages 65 and older in the U.S. will have increased to over 70 million people. By simple math we have every reason to believe that in the next 20 years, demand for generic cancer medication such as doxorubicin and leucovorin -- mainstays of therapy for breast and colorectal cancer respectively, and drugs particularly hard-hit by current shortages -- will increase by at least the same proportion as the over-65 population. Cancer is largely a disease of aging, and the aging population is growing in this country. Neither of these statistics is news.

President Obama has called drug shortages “one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all over the country.” One might say that the aging of the U.S. population is also a slow-rolling problem. Yet we have known for decades that demand for products that treat diseases of aging would explode. And still -- with all these years of advance warning -- we are unprepared. Why would we think that an executive order that requires drug manufacturers to report impending shortages will have a meaningful impact when changing demographics -- one of the most reliable indicators of future demand that can be found -- has not yet motivated us to prepare?

As we've discussed previously, this problem of generic drug shortages requires us to think harder about how to align the commercial vitality of our healthcare industry with the health needs of our society. That problem is a thorny one -- not just because it is intrinsically challenging to solve, but also because we seem unmotivated to solve it. In this matter as in others, we’ve been inclined to treat future as mere possibility -- a bridge to be crossed if and when we come to it. It is easier to deny and temporize than to tackle tough issues if the consequences are not literally upon us. Well, clearly they are upon us now.

Just this Sunday, The New York Times issued the chilling assessment that we are every bit as unprepared for an anthrax attack as the day it first crossed our radar screen, even though prudence would dictate that we take readiness more seriously. In matters of public health, as in every other aspect of public policy, we need to cultivate a keener future orientation.

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