- The Washington Times - Tuesday, March 21, 2000

When human organs are in short supply for transplantation, which patients should be chosen to receive them? And who should choose?

Most Americans agree on the answers: Organs should be allocated to patients according to medical need. And allocation decisions should be made by transplant physicians and other transplant professionals, based on medical criteria.

That's the system Congress sought to establish in the National Organ Transplantation Act. And that's the result the Department of Health and Human Services (HHS) is seeking in its rule on organ transplantation, which went into effect last week.

There are some, like Dr. Anthony D'Alessandro in The Washington Times of March 16, who maintain that the new HHS rule aims at "taking over" the choice of who lives and who dies. That's simply not true. HHS always has and always will look to transplant physicians and the transplant community, both to make day-by-day allocation decisions, and to develop the policies and define the medical criteria that underlie those decisions.

At the same time, our organ transplant system must be accountable to the donors and donor families who give organs in trust; to the patients who rely on the system to deliver the best possible medical results; to the physicians and transplant centers who form the network to serve patients; and to taxpayers, who support more than half of all transplant costs.

Congress established the national transplant system to bring together these different perspectives and to ensure that the system is working as fairly and effectively as possible. HHS has responsibility to oversee that system.

Why are new organ transplant rules needed at all? First, and most simply, they establish the legal ground rules for public review of the nation's transplant policies. The Organ Procurement and Transplantation Network (OPTN) is a national system created by Congress, and transplants are largely paid for by taxpayers, so its policies need to be publicly accountable. The rule establishes legal processes for development and review of OPTN policies.

In addition, however, the rule addresses problems in the current transplant system problems that have prevented the system from fully delivering on its own goals. Today, in too many cases, non-medical criteria like "local-first" allocation rules are preventing organs from reaching patients who need them most. We're not saving as many lives as we could.

The HHS rule recognizes that the national transplant system must be a shared responsibility. Day-to-day transplant decisions are, of course, the responsibility of medical professionals. Development of medical and allocation policies is also the responsibility of transplant professionals in particular, transplant physicians and surgeons in cooperation with transplant centers, patients and donor families. The HHS responsibility is to provide for public accountability, including performance goals for the system, as well as review and approval of policies based on those goals.

This is not the "hostile takeover" suggested by Dr. D'Alessandro. It is a balanced plan, supported by the findings of the Institute of Medicine in the report it prepared for Congress last year.

The lifesaving power of transplant technology is still as miraculous today as when it was developed just a few decades ago and the shortage of organs is still as frustrating. The challenges and dilemmas that face physicians, patients and others in the transplant field are indeed as daunting as Dr. D'Alessandro describes them.

So far, our response to these challenges has been hampered by conflicting interests within the transplant community. But we can achieve a system that will be more cooperative and more effective.

In particular, as the HHS rule provides, the OPTN needs to develop uniform medical criteria for identifying each patient's medical status. And on that foundation we must build better cooperation and broader organ sharing, because cooperation and broader sharing are key to saving more lives.

We need to look ahead to a system that sustains trust, better unites the efforts of the different transplant centers, makes best use of the organs available to us, and serves the nation's patients.

Donna Shalala is secretary of the Department of Health and Human Services.

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