December 2001 - January 2002

Health Care Access and Emerging Medical Technologies: Policy Decisions Cannot Be Made Lightly

by Terrance Malkinson

The health care industry is the third largest employer and second largest service industry in the United States (Schraeder, 2001). Today, this industry is undergoing significant change, both because new knowledge and new technologies are raising complex moral and ethical issues and because of the need to curb increasing health care expenditures. In order to provide affordable and efficient access to quality health care and to take advantage of technology breakthroughs for improved health and quality of life, experts, decision makers, leaders and citizens will grapple with significant ethical and policy issues, for which there will be no easy answers.

Access to Health Care — Community by Community

Health care ranks high on the national agenda. To put it simply, healthy individuals can better contribute to the community and fewer resources are needed to treat disease. Strikingly different challenges to medical policy depend in a large part on individuals' socio-economic status and on the level of economic development in local communities.

Currently, more than 43 million Americans are uninsured. This lack of insurance serves as a barrier to seeking and receiving quality health care. Many delay seeking treatment — or even forego treatment altogether — because they fear the associated high medical bills. Such delays ultimately lead to greater costs within the health care system, as illnesses become more serious and costly to treat.

Many communities are questioning whether existing methods and strategies are the most efficient ways to address health care issues. Rather than waiting for federal and state government action and mandates, many local communities are taking the initiative to restructure assets and use medical technology effectively, in an effort to increase access to quality health care for more citizens. Many efforts have been successful, primarily because local governments can motivate constituents to support health care solutions that meet their needs and can be implemented with local resources (Ketchum, 2001).

Disease management models are being developed to focus on using technology to promote healthy aging, minimize lifestyle-related disease, and manage disease (Adomeit et al, 2001). Several emerging medical technologies provide the tools necessary to manage disease effectively; they reveal health problems earlier, saving insurers enormous amounts of money in treatment costs and reducing lost productivity in the workplace.

These technologies offer the benefit of regular patient monitoring, which helps health care providers identify — and respond to — trouble early. For example, a patient with congestive heart failure in a disease management program could benefit from using miniature implanted telemetric biosensors that would allow for his or her body physiology to be monitored remotely. These biosensors would alert health care providers automatically at the first sign of trouble, allowing them to respond far more quickly.

Similarly, technology exists to monitor blood sugar levels and other important body processes in patients with diabetes. This information is transmitted to health care providers, who can adjust medications and diet restrictions immediately, rather than waiting to conduct in-person testing, analysis and consultation.

Of course, technology will never replace all face-to-face meetings between physicians and their patients. Patient education, training in how to take medications, direct physical examinations by health care professionals, and one-on-one personal interaction will always be critical components of a well-balanced and thorough disease management system.

Cloning — Technology Rife With Moral and Ethical Dilemma

One of the most difficult medical technology policy issues to arise in the history of medicine relates to "cloning." This is a story of extremes. Cloning represents "hope" for a cure to disease for some and "outrage" of our manipulation of the essence of life to others. As with many far-reaching and complex issues, there is no easy answer, nor is there even a "correct" answer. Arguments for and against are compelling and emotional. With hope, research, factual discussion, and introspective thought on the nature of humankind will bring about a responsible policy decision related to cloning. But what is vitally important here is that these technologies be used for "good," moving us forward in ways intended by our having the intellectual and technical capability to uncover knowledge about the basis of physical life.

We must educate ourselves by seeking out diverse opinions and then making our own informed decisions. We must communicate our opinions to medical, religious, technology, and political leaders and decision makers. Only with open dialogue will citizens and decision makers alike carry out their responsibilities effectively. As President George W. Bush stated in his address to the nation on 9 August 2001, "as we go forward, I hope that we will always be guided by both intellect and heart, by both our capabilities and our conscious."

Genetically Modified Foods — How Much is Too Much?

Genetically modified (GM) foods are also evoking strong opinions these days. The term "genetically modified food" most commonly refers to crop plants created using molecular biology techniques for human or animal consumption. These plants have been modified in laboratories to enhance such desired traits as increased resistance to disease and improved nutritional content.

GM food technology has the promise of ensuring an adequate food supply for the growing world population. Other promises include edible pharmaceuticals and phytoremediation of soil and groundwater. On the flip side, concerns fall into the categories of environmental hazards, human health risks, and economics. Product labeling is also a contentious issue, as is determining "acceptable levels" of GM supplements in non-GM products. Government leaders and scientists are working diligently to establish a regulatory process to monitor the effects of and approve new varieties of GM plants. But the regulatory process is complex; several different government agencies (EPA, USDA, and FDA) have jurisdiction over GM foods. Ultimately, medical policy leaders will have to proceed with caution to avoid causing unintended harm to the environment and human health.

The Artificial Heart-It Goes Beyond Simply Prolonging Life

On 2 July 2001, the first human trial of a self-contained Implantable Replacement Heart (IRH) occurred at Jewish Hospital in Louisville, Kentucky. Before this trial could even take place, many important medical technology policy decisions had to be made. The most rigorous patient protection measures and ethical guidelines were determined in advance and are said to be the most thorough and effective ever implemented for a medical device trial (go to www.abiomed.com for more information on the guidelines developed). Under an Investigational Drug Exemption, the Food and Drug Administration gave approval for only five of these experimental surgeries to be performed; the fifth surgery took place on 6 November.

This device has not been approved for commercial distribution and is not available for use or sale outside of this initial clinical trial. Further, its success is not dependent on its ability simply to act as a pump; rather, success will depend upon the device's ability to allow quality of life to continue after the natural heart fails. Decision makers will have to evaluate the results of this trail carefully before making a decision on whether additional investigational surgeries should be approved. After that, it will have to prove itself in long-term use before it becomes widely available.

The first recipient of this breakthrough technology recently died of multiple organ failure, but that is not to say the technology itself has no place in the future of medicine and health care. Despite its infancy, the IRH has changed our perception of what is possible, and was selected as Time Magazine's "invention of the year" for 2001.

Related Policy — There Are No Easy Answers

Today, new knowledge and emerging technologies offer advances in medicine that could only be imaged a few short years ago. This knowledge and these technologies carry enormous complexity, making establishing related technology policy hugely challenging. In the months and years ahead, decision makers and the population as a whole will have to rely on their education, their life experiences, their wisdom, and their ability to accept diverse opinion, in order to develop and implement the policy decisions that are the most sound.

References and Further Reading

Adomeit, A., A. Baur, and R. Salfeld. A New Model for Disease Management. The McKinsey Quarterly 2001 Number 4: 92-101.

Filman, R. editor. Medicine on the Net-from Isolation to Universal Connectivity Special feature IEEE Internet Computing. 5(3): 40-73, 2001.

Kara, A. Protecting Privacy in Remote-Patient Monitoring. Computer 34(5): 24-27, 2001

Kellen, A.S., and S. Van Kuiken. Health on-line. The McKinsey Quarterly. 2000 Number 4:131-135

Ketchum, S. Health Care: Is it a Local Issue? Public Management. 83(7): 6-12, 2001.

Schraeder, M. Health Care. Business Horizons. 44(5): 2-3.

Terrance Malkinson is a proposal manager/documentation specialist with GE Capital IT Solutions Inc. The opinions expressed here are his own.