Credit: Nora Porter

America's influenza vaccine shortage has produced an ethical conundrum: how to distribute 60 million vaccine doses to 100 million people at risk of contracting flu? Due to the lack of protocol to solve such issue, Washington has turned to five bioethicists for help. At the top of the list is Daniel Callahan.

For the better part of the last 35 years, bioethicist Daniel Callahan's notions about life and death, and the role and limits of medical technology, have been at the center of some of America's most important moral debates. He has been pondering these issues from his home away from home, the Hastings Center for bioethics, which he cofounded in 1969 with Willard Gaylin.

Although he is less well known by the general public than the University of Pennsylvania's Arthur Caplan or the University of Chicago's Bush-bioethics-czar Leon Kass, Dan Callahan has arguably proved the public policy value of the field of bioethics in the United States more than anybody alive today. Callahan's poignant musings and questions are refreshingly difficult to typecast as liberal or conservative, reductionist or heuristic.

This father of six is an atheist who is pro-choice, but against physician-assisted suicide and embryonic stem cell research because he sees them as morally indefensible. “He played a huge role in the debate over abortion, physician-assisted suicide and most recently stem cells and biotechnology,” says Joseph Fins, chief of the division of ethics at the Weil-Cornell Medical Center in Manhattan, and a medical doctor, who as a Hastings research associate, has seen the Callahan dynamic firsthand.

Longtime friends like pain specialist Kathleen Foley of the Memorial Sloan-Kettering Cancer Center in Manhattan, whose Project on Death in America provided funding for Hastings in the past, say the importance of being Dan Callahan cannot be overstated. “I can't think of many things that are more important than helping a society come to grips with its life-or-death dilemmas,” says Foley. Dan and his work seem to be more important now than ever before. “We could all learn something from Dan's balanced approach to problem solving.”

One problem that Callahan has yet to solve despite studying it for well over two decades, which has put him at odds with the powerful drug industry lobby—and even some of his peers—will get a new airing in his latest book 'Costs, Choice, and Equity: Medicine and the Market' due to be published towards the end of 2005. This book looks at the ethical and economic viability of the United States' market-driven healthcare system, a $1.3 trillion enterprise that is very much the moral dilemma of the moment.

He says that nothing will change in the United States, however, until the country comes to grips with the 'infinity' model of medical innovation that has come to be regarded as sacrosanct. The infinity model is based on the notion that there is no limit to what biotechnology and medicines can do to improve health and well-being, that corporations are infinitely capable of producing these innovations, and that patients, doctors, investors and the government should infinitely reward the pursuit and delivery of this innovation.

The trouble is that each new innovation often costs more than the one it replaces. Callahan has become increasingly critical of drug companies that defend their product pricing on the grounds of difficulty, economic risk and the expense of developing new drugs. This defense is a symptom, he says, of the infinity model. “The difficulty with a market-driven infinity enterprise is that it admits of no natural or intrinsic limits,” which endlessly forces up costs, Callahan writes in his new book. A central question in his work is: how much is enough medical innovation?

The more Callahan ruminates this infinity model, the more he is convinced that something has to give. “[Pharmaceutical and biotech companies] have taken on a moral duty to look at their market more as patients than customers,” he says. The blockbuster rheumatoid arthritis drug, Enbrel, for example, costs upwards of $12,000 a year. The drug it replaced, methotrexate, cost about $100 per annum. Enbrel is a better drug, but 120 fold better? Callahan views this an ethical question as much as an economic one for America. By that reasoning, he argues, these firms must start showing more concern for these “patients” and make sure their products are affordable. “I know this means less profit and fewer new products each year. Better to have second- and third-tier drugs that everybody can afford than first-rate [drugs] that nobody but the rich can afford,” he adds. He cites the fact that there are now some 45 million US citizens living without health insurance.

Caplan is among those who believe that Callahan is tangling equity with innovation. “I think Dan confuses the profiteering of the biopharma industry with the notion that improvement can only be achieved at greater and greater cost with less access to the least well-off. Agriculture, electronics, transportation and computers show that this just not true.”

Yet, taking the argument further, Callahan even questions the root of medical progress. “Is there really a moral obligation to endlessly conduct medical research? At the very least, there are limits to this obligation.” Caplan, for one, thinks this is nonsense. “There is an implicit contract between the generations, each one sacrificing to help improve and advance medicine and science for the next generation. To renege on this implicit social contract would be to turn our generation into a group of free riders on the sacrifices of the past,” Caplan says. He believes that government, not industry, bears the responsibility of subsidizing greater public access to healthcare.

Boyd Clark, CEO of Pennsylvania-based Neose, and former head of corporate planning at Merck, agrees with Callahan that something has got to give. But as the father of an epileptic child, he disagrees that there is no moral imperative to pursue medical progress. “But there is no question, we're going to have to figure out how to achieve this innovation in a more cost-effective manner.”