Thursday, August 13, 2009

The end of medical miracles?

A universal, single-payer health care plan may make year 2009 cures available to all, but it may prevent the development of year 2010 cures.

Liberals and conservatives appear to agree on the need to unleash the possibilities in medical discovery for the benefit of all. But it cannot be ordered up at will. It takes approximately ten years and $1 billion to get a new product approved for use in the United States. Furthermore, only one in every 10,000 newly discovered molecules will lead to a medication that will be viewed favorably by the Food and Drug Administration (FDA). Only three out of every ten new medications earn back their research-and-development costs. The approval success rates are low, and may even be getting lower—30.2 percent for biotech drugs and 21.5 percent for small-molecule pharmaceuticals.

It is the very nature of scientific discovery that makes this process so cumbersome. New developments do not appear as straight-line extrapolations. A dollar in research does not lead inexorably to a return of $1.50. Researchers will spend years in a specific area to no avail, while other areas will benefit from a happy concatenation of discoveries in a short period. It is impossible to tell which area will be fruitless; so many factors figure into the equation, including dumb luck. Alexander Fleming did not mean to leave his lab in such disarray that he would discover that an extract from moldy bread killed bacteria, yet that is how it happened. Conversely, if effort and resources were all it took, then we would have an HIV/AIDS vaccine by now; as it stands, the solution to that problem continues to elude the grasp of some of the most talented and heavily funded researchers.

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The life sciences are among the most regulated areas of our economy, and are constantly subjected to significant policy upheaval from Washington. Because these products are so expensive to develop, the regulatory and policy whims of Washington tend to have a disproportionate impact on investment in the industry. Without investment, there is no research, and without research, there are no products. According to Ken Kaitin of the Center for the Study of Drug Development at Tufts, new drug approvals from the Food and Drug Administration are not keeping pace with rising research-and-development spending, which means that recent spending has not been leading to results. This raises the question of how long such investments will be sustainable if they do not provide sufficient return for investors.

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We have a market economy, and this system allows U.S. firms to put in the dollars for research and development that make innovative new products possible. Elizabeth Whelan of the American Council on Science and Health has observed that the U.S. "produces nearly 90 percent of the world's supply of new pharmaceuticals." The pricing structure in the United States, which allows American firms to recoup research costs, makes this industry the dominant player in the global medical-products market. Without it, innovation could grind to a halt, and future generations might not benefit from life-saving, life-extending cures just over the horizon.

And this loss is not just a theoretical one. It can be quantified. A study by the Task Force on Drug Importation convened by the Department of Health and Human Services found that the loss of profits caused by re-importation could lead to between four and eighteen fewer drugs per decade. There is no way to know which promising enhancements would be lost.

At the same time, as Sally Pipes of the Pacific Research Institute has shown, the American system also lets its consumers obtain many products far more cheaply than consumers in other nations. This is because our competitive system allows for low-cost generic drugs that drive down prices. Brand-name products are more expensive here, but generics, which are available after patent protections expire, are cheaper and more widely available in the United States than elsewhere.

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These activities raise the troublesome possibility that the FDA will adopt the old motto of the cautious bureaucrat: "You won't be called to testify about the drug you didn't approve." But when innovation is squelched, who can testify for the life that would have been saved? FDA timidity is especially problematic and often detrimental to public health when it comes to risky new drugs for cancer or new antibiotics for increasingly resistant infections.

Then there is the looming shadow of health reform. One of the great requirements of a systemic overhaul is controlling costs, which were $2.5 trillion last year and growing at a rate triple that of inflation. It is clear that Congress and the administration will have to cut costs in order to come close to paying for an ambitious plan. How they do so could have a devastating impact on medical innovation.

Attempts to universalize our system and pay for it with cost controls that could stifle innovation contradict their own goal, which is, presumably, better health. It also embraces the notion that you can get something for nothing—namely, that you can get innovative new discoveries and better health outcomes somehow without paying for these discoveries to come into being.

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We forget the power of the single-celled organism. For most of man's existence on earth, the power of a single-celled animal to snuff out life was an accepted—and tragic—way of the world. Human beings could be wiped out in vast communicable plagues or simple through ingesting food or water. In the last century, the advent of the antibiotic has changed all that. For millennia, the only cure for an infection in humans was hope. Today, antibiotic use is so common that public health officials struggle to get people not to overuse antibiotics and thereby diminish their effectiveness.

Just as there is potential danger from the way in which Americans take the power of the antibiotic for granted, so, too, one of the greatest threats to our health and continued welfare is that Americans in the present day, and particularly their leaders, are taking for granted the power, potency, and progress flowing from life-saving medical innovations. And in so doing, they may unknowingly prevent the kind of advance that could contribute as vitally to the welfare of the 21st century as the discovery of the antibiotic altered the course of human history for the better in the century just concluded.

 

1 comment:

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