A Quarter Century of Health Maintenance

IT WAS QUITE a year. Americans saw a Congress trying to pass legislation regulating health maintenance organizations (HMOs), a beleaguered president facing an impeachment inquiry, and New York and California baseball teams meeting in the World Series . . . welcome to 1973!

Twenty-five years ago, President Richard Nixon, while trying to avert impeachment, still had time to sway Congress and pass the HMO Act of 1973, a piece of legislation that legitimized a philosophy of health care delivery that ultimately changed the face of medicine. (And back then it was the Oakland Athletics defeating the New York Mets to capture the series.)

But what effects on medicine did the HMO Act actually have? Many experts say, "Not much." They note that managed care dominates the current health care environment because of employers who sought insurance alternatives in the 1980s when medical costs climbed at double-digit annual growth rates.

Joel Shalowitz, MD, a professor and program director at Northwestern University's J. L. Kellogg Graduate School of Management, said recently that, while the act may not have changed medicine overnight, it did legitimize the concept of prepaid health care, making it easier for employers to embrace.

"There was a federal qualification element in the act that at least put forth some standards," Shalowitz said. "Business was looking for that Good Housekeeping Seal of Approval."

But along with a seal of approval came mandates and other rules that made the HMO concept unattractive for others, said Alan L. Hillman, MD, director of the Center for Health Policy at the University of Pennsylvania.

"The HMO Act of 1973 didn't have much impact—there were fairly constraining requirements placed on them at that time and not many new ones came on line," Hillman said. "The HMOs didn't start to take off until the early 1980s, when the constraints on them were lifted. So after 25 years, it's nice to have a birthday celebration, but remember it wasn't until its bar mitzvah [ie, at about age 13] that the HMO came of age."

Scott Sirotta, executive vice president and chief operating officer of the Blue Cross and Blue Shield Association, said, "The act gave HMOs a foothold. It encouraged plans to get into the business and forced employers to innovate and create new coverage. It provided a jump-start to the industry."

And what of the HMO Act's legacy over these 25 years? Karen Ignani, president of the American Association of Health Plans, the HMO trade association, said, "The act encouraged the development of managed care—in the short term, HMOs, but in the long term, preferred provider organizations, point-of-service plans, and other forms of managed care.

"Health plans were built on the principle that they should be held accountable, that they should provide quality care while containing costs."

Jim Bentley, senior vice president for strategic policy planning at the American Hospital Association, said some of his member institutions like managed care and others do not. "For hospitals, the act provided some early learning experience in cost containment while maintaining quality," Bentley said.

Nancy W. Dickey, MD, president of the American Medical Association (AMA), said passage of the HMO Act had a profound effect on medicine.

"I think managed care was only allowed to happen by the federal leg up the HMO Act offered. We have literally seen the health marketplace transformed," Dickey said. "I think some of it has been good—accountability and integration of services, for example. But the bottom-line mentality by some HMOs and changes in incentives that alter how physicians treat patients have created at least as much angst as the positives have created good."

The original act preempted restrictive state laws, defined federally qualified HMOs, required annual open enrollment periods, assured quality standards, mandated that certain employers offer indemnity and HMO coverage, required equal employer contributions to indemnity and HMO coverage, and offered grants to help new HMOs get into the business.

The legislation was enacted during a time when Nixon was saying the United States faced a health care crisis because of high costs generated by the still-new Medicare program. In February of 1971, Nixon asked Congress to develop a national strategy to use the government to move health care coverage from indemnity to privately operated prepaid health care. Passage of any such bill was difficult since the powerful AMA stood in opposition. But finally a bill did pass, and on December 29, 1973, Nixon signed it into law.

One of the fathers of the HMO is Paul Ellwood, MD. Ellwood invented the name health maintenance organization. Today, watching his child grow, Ellwood has mixed emotions.

"The HMO Act and other proposals have permanently revolutionized medical care in the United States," he said. "The first phase has shifted power from physicians and insurers to large-group purchasers of medical services. This has reduced the growth of expenditures by about $500 billion.

"Unfortunately, the purchasers neglected the other component of the HMO proposal, that is, quality and competition. The next phase of the evolution will involve another power shift. This time consumers and patients will gain the upper hand by exercising choices based on objective comparisons of quality."

Ellwood continued, "For those of us who devoted our lives to reshaping the health system—and where our motives were typical of many physicians, trying to make the health system better for patients—the thing has been a profound disappointment."

The theory behind HMOs—that coordinated care could treat acute episodes and improve patients' health during their lifetimes while controlling costs—remains just that, said Uwe Reinhardt, PhD, the James Madison Professor of Political Economy at Princeton University.

"HMO is a misnomer," Reinhardt said. "Most don't engage in health maintenance. The tenure of the enrollee isn't long enough to make those up-front investments worthwhile. What you do have are these amorphous creatures that are basically organizations that regulate the patient-doctor relationship. HMOs are private-sector health care regulators."

1973 was a historic year for many reasons in addition to passage of the HMO Act.

In January, the Vietnam cease-fire went into effect, ending direct involvement of United States ground troops.

Southeast Asia wasn't the only place experiencing war that year. On October 6, the Yom Kippur War got under way as Egypt and Syria tried to regain land lost to Israel in the 1967 war. Middle East tensions also resulted in the first oil embargo by members of the Organization of the Petroleum Exporting Countries (OPEC).

On the home front, the break-in at Democratic National Headquarters in the Watergate Hotel and the question of President Nixon's role led to talk of impeachment. Watergate begat the Senate Investigating Committee chaired by Sen Samuel J. Ervin, Jr (D, NC) and the subsequent "Saturday Night Massacre" when Nixon fired Watergate special prosecutor Archibald Cox.

In a lighter vein, 1973 was the year many Americans saw The Exorcist and The Sting at the movies, read Fear of Flying by Erica Jong, and listened to "Tie a Yellow Ribbon Round the Ole Oak Tree" by Tony Orlando and Dawn. The biggest sporting event was the "Battle of the Sexes" in tennis, when Billie Jean King beat Bobby Riggs.—M. L. M.

FINDING the locus for ethical responsibility in the realm of managed care has become great sport among medical and health care organizations in recent years. Initially, conference programs designed to explore this subject focused on identifying and assigning blame for the problems associated with managed care. More recent programs contain civil and reflective analysis of the complexity of the problems and discussions of potential solutions.

The American Society for Law, Medicine & Ethics (ASLM&E), with its diverse membership from the fields of law, medicine, ethics, and public policy, is well poised to address these complexities. It did so by sponsoring a conference, held in Cambridge, Mass, in October, to "explore the components of an ethical framework for managed care decision making that incorporates patient interests and concerns."

A diverse faculty of experts (ie, those who have been through managed care battles) seemed to share a sense of the complexity and magnitude of the task before them and a general awareness that the reason ethical responsibility in managed care is hard to find and define relates to (1) the different perspectives that physicians, plan managers, and patients have as to who should be responsible to whom and for what, (2) the different and continually changing kinds of service structures and arrangements under which managed care operates, and (3) the different views on how to hold people responsible for just and ethical decision making.

The major part of the program was six plenary sessions, each one devoted to examining a particular area of responsibility within managed care settings that begs for ethical consideration. These included governance, service structuring, utilization management, quality, marketplace behavior, and dispute resolution. Here are some highlights from several of these sessions.

Managed care is still evolving, and one of the new entities gaining favor is the integrated delivery system (IDS). It comes in two varieties. When first used, the term referred to horizontally integrated systems that create a continuum of health care services that allows patients to be treated in the most appropriate, cost-effective setting. "Horizontal" meant that the array of providers should include tertiary and acute care hospitals, rehabilitation centers, nursing homes, physicians' offices, urgent care centers, and home care organizations.

Later, vertically integrated systems were described, wherein the health care systems unite the financing mechanism, or health insurance product, with health care providers such as hospitals and physicians, thereby aligning incentives to manage patient care. Under vertically integrated health care, provider and payer are united into a seamless system with a powerful synergy to control costs, enhance quality, and increase market share—or at least so it is described on paper.

A pioneer in this kind of arrangement was the Kaiser Permanente system, which has successfully competed as a health maintenance organization (HMO), a physician group practice, and a health care delivery system.

Richard N. Gottfried, JD, chair of the Committee on Health of the New York State Assembly, is a proponent of the IDS concept, but he also acknowledged "the danger that the hazards of the marketplace or lack of managerial expertise will bring the IDS and its provider-practitioner members to financial ruin." He assumes that, with safeguards, this debacle can be avoided. "But there is a grave danger that the mission of nonprofit or public providers and the professionalism of practitioners will be lost in the IDS," Gottfried said. He would like to see safeguards established, based on governance principles, that would prevent the IDS from pulling practitioners out of the professional sector and pushing them into the corporate sector, under corporate control.

"First, everyone involved must understand that it does make a difference," Gottfried said. "Managers of a nonprofit provider have a legal obligation to adhere to its mission statement. Practitioners have a legal obligation to follow professional standards and ethics and act in the patient's interests. None of these are mandates of the corporate sector. Managers of a corporate provider [only] have a legal fiduciary obligation to maximize the return to shareholders.

"The issue is not necessarily whether the provider offers ‘quality' care," Gottfried continued. "The issue is what guidelines the practitioners follow, which services they will expand or reduce, who they reach out to, and where they target their resources."

Not everyone agreed that such safeguards and governance actions would be sufficient to assure ethical responsibility to patients. Ronald M. Green, PhD, of Dartmouth College, Hanover, NH, pointed out, "With the reality of direct economic accountability reduced, ethical and legal forces have frequently shown themselves to be inadequate to pick up the slack." He contended that even attention to mission statements, physicians' exercise of their fiduciary obligations to patients, and, where needed, regulatory interventions—the forces that Gottfried relies on to keep the IDS in line—are not yet sufficiently developed to assure primary attention to the quality of patient care.

Green cited and agreed with the work of others who have observed that even the legal fiduciary obligations of physicians are poorly developed in this respect. "Although these obligations exert pressure against gross misconduct and breaches of confidentiality," he said, "they don't ensure that physicians will always strive to see that their patients' interests are well served in an adverse institutional environment. Put another way, in the moral-legal firmament of managed care, responsibilities to owners or corporate clients are often the stars that outshine all others. The result is that the patient faces a ‘phantom fiduciary' as well as a ‘phantom gatekeeper.'"

Another example of how ethical responsibility to patients is given short shrift came from Linda B. Miller, president of the Volunteer Trustees Foundation for Education and Research, a consumer advocacy group, who pointed out that even not-for-profit environments can harbor the same subordination of patients' health care needs as for-profit organizations. With boards of trustees poorly guided by existing legal standards, they can often put personal and institutional needs, as they perceive them, ahead of those of individual patients.

No grandiose solution was suggested. Green anticipates many partial solutions. "In the essential and ethical sense," he said, "I believe there is a need to develop a single, authoritative center of ethical and fiduciary responsibility for the patient's health. That might take the eventual form suggested by Richard Gottfried: integrated delivery systems owned and controlled by institutions and practitioners who are also independent of corporate control. But whatever the specific ownership pattern—whether it is a for-profit or not-for-profit organization, an HMO or IDS—medical decision making by and accountability by medical practitioners is central. Medical professionals alone have the knowledge and the aptitude to fight for patients' interests. Institutional mechanisms have to be found that free them of conflicts of interest and give them, as a body, sufficient power within managed care organizations to exercise their professional competence. That competence should be in conversation with the organization's fiscal needs. But it should never be allowed to become a phantom voice in managed care deliberations."

In the plenary session on the ethics of structuring services, Joseph L. Dorsey, MD, corporate medical director and senior vice president of Harvard Pilgrim Health Care Plan (HPHC), referred to the "difficult balancing act" involved in meeting the plan's fiduciary and stewardship imperatives. Dorsey provided insight into how the plan's Ethics Advisory Group used a process he referred to as "reflective equilibrium" to define "ethical guideposts" that the management team could use to compare drug coverage options:

In the utilization management session, Sara Rosenbaum, JD, of George Washington University, Washington, DC, tied the ethical issues to the following questions regarding treatment decisions in managed care: Who gets to define medical necessity and resulting care? What is the scope of that definition? How are medical necessity decisions made, and what types of evidence are used in such decisions? Who bears the burden of proof? Should certain decisions be excluded for external reasons? Too often in managed care, she said, answers to these questions are decided behind closed doors.

In his wrap-up commentary, Bernard Lo, MD, professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco, said that, although physicians should make the ultimate decisions in utilization management, they are no better than any other group in dealing with heavy-handed utilization reports and authorizations and financial incentives, nor are they any better at defining risk assessment.

Some ways health care organizations can respond to incentives for decreasing services, Lo said, include disclosing economic incentives to patients, placing limits on economic incentives, creating incentives to strengthen the patient-physician relationship, and ensuring high-quality care. Physicians can respond to incentives that decrease services by disclosing conflicting interests, informing patients when standard care is not available, serving as patient advocates, and minimizing financial considerations.

The plenary session on quality covered three approaches to ensuring an ethical component in managed care. The first, which was summarized by David Cullen, MD, MSc, chair of the Department of Anesthesiology at St Elizabeth's Medical Center and professor of anesthesiology at Tufts University School of Medicine, both in Boston, is to design systems that avoid the problems that result in ethical complications This approach was exemplified by the Harvard Medical Practice Study on Institutional Error Reduction (JAMA. 1994;272:1851-1857) and addressed in a recent editorial (JAMA. 1998;280:1444-1447).

The second approach to quality is to give consumers a more direct voice in managed care organizations. Marc A. Rodwin, JD, PhD, of the School of Public and Environmental Affairs at Indiana University in Bloomington, explained that the traditional marketing view that unhappy consumers can just switch to a competing health plan is no longer a genuine option. Instead, he suggested that "publicly owned managed care organizations establish elected consumer councils to provide continuing advice and feedback without formal authority to make management decisions. Councils could express their views on issues that affect members and work with management to improve the organization's performance.

"Building voice into managed care organizations," he said, "can help build stronger organizations by putting managers in touch with the experience and desires of their customers, the patients. If those customers become sufficiently discontented, they will eventually call on legislatures to act on their behalf, as they did when HMOs cut hospital maternity stays to 24 hours." Rodwin said he believes that the managed care industry will face increasing constraints, as shown by the recent spate of consumer protection legislation, and that those who claim that a consumer voice in managed care affairs would be impractical should contemplate the alternatives.

The third approach to quality is via regulation. Despite the surge in statewide consumer protection legislation against managed care practices, David A. Hyman, JD, of the University of Maryland Law School, contends that such initiatives "tend to be long on crowd-pleasing rhetoric, but short on practical and cost-effective solutions."

Hyman noted that regulatory control has a wide philosophical overlay, depending on one's view about the relative roles that government and markets should play in health care. Hyman offered a number of reasons why consumer protection initiatives will not be satisfactory in the long run.

"The health policy problems of the present day [lack of insurance, highly variable quality, spiraling costs, and uncompensated medical harms] did not begin with the development of managed care," he said. "These problems have existed for decades but were generally ignored in the pursuit of professional and institutional self-interest." So-called solutions to these problems rendered via consumer protection measures rarely have any scientific-based evidence of support, leaving everyone with only "gut instincts, bad anecdotes, and popular appeal" to assess the merits of proposed reforms, he added.

"Even when the legislature successfully identifies a real problem, the issue is invariably more complex than it first appears, and the proposed reforms suffer from their own shortcomings, even without factoring in and usually carefully ignoring the economic implications," Hyman said. In many cases, "the drafting of consumer protection initiatives is often hijacked by providers, who have their own interests at heart."

By the end of the meeting, there was general agreement that ASLM&E had accomplished its conference objective in that various components of an ethical framework for managed care decision-making were explored, and that these components incorporated the different perspectives, interests, and concerns that physicians, plan managers, and patients have regarding where ethical responsibilities lie. But in doing so, the complexity and magnitude of the task had become all the more obvious.

What's needed now, participants agreed, are new ideas, models, or visions of how to bring together these disparate—and sometimes desperate—voices to foster new levels of understanding, develop new techniques for resolving disputes, agree on new areas of shared values, and seek cooperative ventures aimed at providing mutual benefits for everyone involved.

JUST OVER 50 years ago, on June 16, 1948, President Harry S Truman signed into law the legislation that created the National Heart Institute. Renamed the National Heart and Lung Institute in 1969, it became the National Heart, Lung, and Blood Institute (NHLBI) in 1976.

This component of the National Institutes of Health in Bethesda, Md, started with an appropriation of around $500,000; today, its annual budget is close to $1.8 billion. Claude Lenfant, MD, director since 1982, reviews some of the highlights of five decades of research on heart diseases, pulmonary disorders, and issues related to blood.

JAMA: What led to the creation of the institute?

Dr Lenfant: We were experiencing what was called an "epidemic of coronary heart disease." Between 1900 and 1948 there had been a steady increase in heart disease deaths, and considerable anxiety about this situation among public health officials led to the creation of the institute. Three prominent figures helped get Congress to create the institute and the Public Health Service to address the problem: philanthropist Mary Lasker, heart surgeon Michael DeBakey, MD, and Claude Pepper, a Florida congressman.

Of course, the mere existence of the new institute did not have an immediate effect on heart disease mortality. But in part as a result of efforts it supported, by the mid-1950s mortality from heart disease began to decline—and the decline has been fairly consistent over the years, especially among middle-aged men. Today mortality from heart disease has shifted to much later in life.

JAMA: Describe these early attempts at tackling heart disease.

Dr Lenfant: Among the first programs that contributed greatly to a decline in coronary heart disease were the myocardial infarction research units (MIRUs), created when James Watts became director (see sidebar) and continued under William Stewart and Robert Grant. They were the origin of today's coronary care units for the treatment of acute myocardial infarction, and they mark the beginning of the institute's focus on prevention.

One reason for the success of these and later efforts was the concept of risk factors that emerged from the Framingham Heart Disease Epidemiology Study (JAMA. 1998;279:1241-1246). The data from this long-term observational study showed that high blood pressure, smoking, and high serum cholesterol levels were major factors in heart disease. The clear implication was that controlling these could make an impact. The finding of a strong association between elevated serum cholesterol and heart disease also made the institute a real leader in this field because of the work on lipids done here by C. B. Anfinsen, Donald Fredrickson, and Robert Levy. Their work put cholesterol on the map.

JAMA: In the mid 1960s the institute actively supported attempts to develop an artificial heart. How and why did this get started?

Dr Lenfant: In those days, people really thought that one of the solutions to heart disease was the artificial heart; work toward it became something like a Manhattan Project. Frank Hasting, a cardiac surgeon, was brought in to mount this gigantic program. He had developed a 30-year flowchart that laid out the way the device would be developed, and he ran the program with an iron fist. Indeed, he was so passionate about the artificial heart that he antagonized a lot of people.

Ted Cooper, who became director in 1968, took issue with this dictatorial approach. He said the effort should not be so tightly run within the institute but must be more open, encouraging input from universities and reaching out to a broad spectrum of researchers. I had worked on an extracorporeal lung machine in Europe, and when I came to the institute in 1970, he asked me to implement his approach as well as set up programs in the newly formed lung division.

JAMA: But total artificial heart devices have never been successful as more than a temporary measure. Today transplantation has been at least some answer to terminal heart disease.

Dr Lenfant: The effort was not entirely wasted. Many good things came out of it, such as temporary assist devices, development of materials compatible with blood, and so on. We continue working on the artificial heart, but not to the extent that we did in those days.

I think heart transplantation will eventually also become less important. Basic research is opening up new avenues that likely are the hope for the future in the treatment of congestive heart failure. I can envision the time when you could put reproduced stem cells into the myocardium, turn on the gene that leads to differentiation, and have, as it were, organ reconstruction in vivo.

JAMA: When the institute became the Heart and Lung Institute in 1969, did it acquire a new responsibility?

Dr Lenfant: The institute was already supporting research into the pulmonary-respiratory system, but many people complained this was not enough. Groups such as the American Lung Association were pushing hard in Congress to create a separate lung institute. But Ted Cooper said it made no sense to have a lung institute when there is such a close association between the heart and the lungs, that they should be together. A compromise was reached, and the name of the institute was changed to include "lung."

One of its most important contributions thereafter was the development of surfactant synthesis for the management of respiratory distress in premature infants. The studies that led to its development were all supported by the institute, and the use of this surfactant has reduced mortality from respiratory distress from about 50,000 deaths a year to between 5000 and 10,000.

JAMA: In 1976 the institute's name was changed again when "blood" was added. Why was that done?

Dr Lenfant: The institute had long been supporting hematological research, but this addition emphasized it. NHLBI supports a great deal of work on such things as hemoglobinopathies, thrombosis, hemostasis, and cellular hematology. Then there are issues of blood safety and utilization, and we take some credit for the development of what is now called transfusion medicine, which includes the appropriate use of blood fractions instead of whole blood.

We also started the Blood Resource Education Program in 1983 because the then three main blood-gathering groups—the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centers—weren't coordinating their efforts. We brought them together, and they began to realize that it was useful to each to work together, so they began to fulfill the goal of the program to improve the management of blood as a national resource. In 1987 we discontinued the program, since there was no longer any point in keeping it going.

JAMA: What about the role of basic research in the NHLBI?

Dr Lenfant: Things are changing. We are more and more translating research findings into the clinic. But without basic research we could not have advanced our preventive programs. For example, I think it's fair to say that Eugene Braunwald was the architect of what we know today about the pathophysiology of heart disease. His contributions were enormous. His work on ejection fraction, heart rate, cardiac output, myocardial tolerance . . . much of our present knowledge on the hemodynamic pathophysiology of heart disease is due to him. Nevertheless, I feel that we must work very hard to connect basic research with clinical issues. Bench scientists sometimes forget that they may become patients themselves.

JAMA: In 1972 the US government developed an exchange program, in which the NHLBI participated, on health and medical research with the Union of Soviet Socialist Republics. How did that work out?

Dr Lenfant: This was, and is, a very important move. Relations between the US and the USSR were pretty bad at that time. The program established a bridge between the Soviet Union and this country which, regardless of the scientific issues, politically resulted in a huge amount of goodwill on both sides of the globe. I think that is one of the real values of the program.

Many of the details of this cooperative program were worked out with Eugene Chazov, who had trained under Paul Dudley White in Boston. He was, and still is, director of the Cardiology Center in Moscow and was the physician to the Kremlin. He very much wanted this venture to succeed, and he put a great deal of effort into it. He, along with Bernard Lown, was one of the leaders in the International Association of Physicians for the Prevention of Nuclear War, the group that won the 1985 Nobel Peace Prize.

The program conducted some very important studies, including some on the pathogenesis of arteriosclerosis, the management of ischemic heart disease, myocardial metabolism, blood components and blood transfusion, and hepatitis prevention. While it's important to do such studies in this country, it is also important to compare findings with similar studies in another country. By such cross-references, one can identify issues—such as different risk factors—that might not appear in one environment but appear in another.

JAMA: In 1972 the institute started a nationwide program of hypertension information and education. How is this program doing?

Dr Lenfant: At that time, the secretary of the Department [of Health, Education, and Welfare] was Elliott Richardson. His father had died of a stroke, and Mary Lasker seized on this as an opportunity to convince him that it was important to start a national program on high blood pressure education. So Richardson ordered Ted Cooper to start the program. Overall, I think the program has done very well.

But today we find ourselves in a difficult situation. We are no longer seeing improved compliance; perhaps physicians are becoming less attentive and patients are becoming less compliant, so we have begun to see an increase in death rates from stroke. At the American Heart Association's meeting last month, there was a lot of discussion about what should be done to increase compliance with antihypertension measures.

In 1985, the National Cholesterol Education Program was started, in 1989 the National Asthma Education and Prevention Program, and in 1991 the Obesity Initiative. It's too soon to say whether the Obesity Initiative is successful, but there's no question that the cholesterol program has been very successful, as has the asthma program. It's interesting to note that it's only in the past 15 years that obesity has emerged as a critical risk factor in heart disease. That's not because people were not overweight before, but because all the other risk factors have been reduced except for obesity, which keeps increasing in our population.

JAMA: During this time the institute began supporting a number of large intervention trials, such as the Hypertension Detection and Follow-up Trial, the Lipid Research Clinics Coronary Primary Prevention Trial (LRC-CPPT), and the Multiple Risk Factor Intervention Trial (MRFIT). How was that effort received?

Dr Lenfant: These trials were very controversial. They were started as a result of the data from Framingham and were a direct attempt to modify the identified risk factors. My feeling is that they were very important, but the scientific community had lots of concerns, the principal one being they were so expensive. Then when the data came out, the results were sometimes equivocal. I became director of the institute in July, 1982, and a few months later we had a press conference to report the results from MRFIT. The findings were not clear-cut—there was no conclusive evidence that the intervention group did better than the usual care group. Everybody jumped on me saying it was a lousy trial, it showed nothing, and look at the money you wasted!

Then there was the LRC-CPPT. The results showed a decline in deaths from coronary disease, but there was also an increase in noncoronary deaths. So people said, well, you are lowering cholesterol but you are killing people anyway!

The problem with these trials is that they were done for only a relatively short time, 5 or 6 years. But since we have continued to follow the subjects in the lipid trial and MRFIT to see what happened to them, we have found some good long-term results. For example, in MRFIT there has been a decline in the heart attack death rate of those subjects who received intensive care compared with those who were in the usual care group.

JAMA: The institute has supported some important studies evaluating drugs and procedures for treating heart and blood vessel diseases. Would you mention a few?

Dr Lenfant: The Beta Blocker Heart Attack Trial in 1981 showed the benefit of propranolol compared with controls. The Coronary Artery Surgery Study in 1983 showed that patients with mild symptoms of coronary artery disease can safely defer bypass surgery until symptoms worsen. In 1991 came the results from the two Studies of Left Ventricular Dysfunction (SOLVD), one on prevention and one on treatment. In the treatment study there was a reduction in deaths attributable to progressive heart failure, and there was also a 26% decrease in hospitalization due to heart failure. The impact of that study on the treatment of heart failure has been quite sensational. It has considerably reduced the cost of treating these patients.

The institute was instrumental in opening the door to thrombolytic therapy for coronary heart disease with the Thrombolysis in Myocardial Infarction (TIMI) trial, which came out in 1985. There have been many other trials since, dealing with various aspects of thrombolysis, but the impetus was TIMI.

An interesting trial was the Cardiac Arrhythmia Suppression Trial (CAST). Antiarrhythmic drugs were being successfully used to treat patients with life-threatening ventricular arrhythmias, and physicians were beginning to use them for mildly symptomatic arrhythmias as well. We were asked to demonstrate that these agents were useful for these milder conditions. To our surprise, we found that, as the study progressed, patient survival worsened. The result was to revise the indications for the use of these drugs.

JAMA: What do you think lies in the future?

Dr Lenfant: There's no question that molecular approaches are going to have a significant impact. It will take a while, but I can see the time when we will be able to repair heart cell damage. Then I think one development that has the greatest potential is pharmacogenetics. I can see the time when we will identify those patients who will be responsive to a particular drug or develop a medication that intervenes on the specific gene product. And as for the potentiality of stem cell development, some may call it "futuristic nonsense," but I disagree. I see it happening.

LAW-ABIDING gun owners would like to keep guns out of the hands of violent criminals, said professors of law, economics, criminology, and criminal justice who attended a conference hosted by Academics for the Second Amendment in mid November in Washington, DC. However, they were quick to add, handgun control laws may have the opposite effect.

Policies designed to prevent violent criminals from buying guns legally often do more harm than good, said Joseph Olson, JD, professor of law at Hamline University School of Law in St Paul, Minn, and president of Academics for the Second Amendment. Law-abiding citizens may be unwilling to take the time and trouble to apply in person for permits and fill out paperwork to obtain weapons for self-defense. Criminals, on the other hand, can obtain stolen guns on the street at discounted prices with no waiting period, he said.

To deter criminals from acquiring and carrying guns, he said, existing gun laws should be enforced. Olson, who helped write a Minnesota law with severe penalties for illegal gun trafficking, says that the law has been inadequately enforced. Consequently, criminals ignore it.

Gary A Mauser, professor of business administration at Simon Fraser University in Burnaby, British Columbia, referred to his review of four evaluations of a Canadian criminal background check law. "Three of four studies showed no effect on homicide rates in Canada."

It would be a mistake, said Olson, to extend US federal firearms laws that currently prohibit gun sales to convicted felons to apply to persons convicted of misdemeanor crimes as well. "Many people plead guilty to misdemeanors to avoid having to hire a lawyer and go to court," he said. People charged with misdemeanors may even have been advised to plead guilty by their attorneys, said Olson, because the attorneys believed that there were no adverse consequences to having a misdemeanor conviction on one's record. Now, perhaps never having been convicted of another offense, their clients could have problems getting a handgun legally.

To maximize the likelihood that only violent career criminals are affected, recommended Olson, only persons convicted of felony crimes should be prohibited from buying handguns. If there is strong public interest in extending this prohibition, he added, then perhaps only persons convicted of three or more violent misdemeanors in a 3-year period should be prohibited from buying guns.

Academics for the Second Amendment was established as a tax-exempt educational organization in 1982. According to a request for financial support authored by Olson, the organization "seeks to foster intellectually honest discourse on the Constitution, the Bill of Rights, and, of course, the environment in which academics, judges, politicians, and the public place the rights preserved by the Second Amendment." The organization holds conferences yearly to critique research and expert and popular opinion on gun ownership and use.

At the recent conference, speakers argued that self-defense is a practical necessity. "The police cannot protect you," said Don B. Kates, Jr, an attorney and writer from Novato, Calif, who moderated the conference. There aren't enough police to protect each individual citizen, he said, "and yet they are actively working to keep you from protecting yourselves." The major threat to an individual's ability to protect himself or herself from criminal predation or government oppression, agreed participants who spoke at the conference, would be a universal ban on handgun ownership.

Chester L. Britt, PhD, an assistant professor in Pennsylvania State University's Crime, Law, and Justice Program, presented his research challenging the findings of a 1991 evaluation of the Washington, DC, law banning ownership of guns. "When we extended the period of observation of the original evaluation by 2 years and used the city of Baltimore as a comparison population rather than the suburbs of the District of Columbia," said Britt, "we found that the gun ban did not reduce homicide rates as the original evaluation concluded." Commenting on this and other refutations of firearm injury research published in biomedical journals, Kates concluded that "the gun battle has been won in the criminology literature." However, he added, "it will never be won in the medical literature, because they only publish one side of the story."

David B. Mustard, assistant professor of economics at the Terry College of Business, University of Georgia at Athens, a coinvestigator on a widely publicized study of the effects of concealed weapons laws on crime rates (Lott JR. More Guns, Less Crime: Understanding Crime and Gun-Control Laws. University of Chicago Press, Chicago. 1998), presented some of his findings at the conference. In short, concluded Mustard, states with laws permitting persons who meet certain criteria (which varies by state) to carry concealed weapons had less crime than states without concealed weapons permit laws.

The right to purchase and carry firearms not only protects the gun owner from violent individuals, said Kates, but also from a potentially violent government. The state holds power over its citizens, he said, and the state is made up of individuals—"some evil, all faulty. Those who oppose gun ownership are engaged in a mythology that denies this." In answer to those who may say that governmental oppression is unlikely in a modern, civilized state, Kates responded: "No historian in the year 1900 would have predicted that Germany would kill Jews. It is impossible to predict that cultural genocide won't happen."

Citing recent historical examples of the slaughter of unarmed Cambodians and Rwandans, Kates speculated that the outcome might have been different had the victims been armed. "No modern army has been able to overcome a determined citizenry. That's why there is an Ireland, an Israel, a victorious Vietnam," said Kates. Altogether, he said, "116 million people have been murdered by their governments in this century alone. So who's more untrustworthy, the government or the people?"

It may seem futile to fight a modern army with handheld weapons, but even against superior firepower, it is still important for individuals to be armed, insisted Olson. "It's about self-respect," he said—even if you can't win, it is better to resist than to allow yourself to be killed. A gun ban would render the individual citizen defenseless, he said. Consequently, many gun owners consider gun bans to be a form of "cultural genocide," he said, "and if we react strongly to that, you shouldn't be surprised."

FLIGHT, said John Glenn, paraphrasing an aviation truth on the eve of his second space mission, isn't inherently dangerous but can be unforgiving of the ill-prepared. The same might be said of the physician who seeks to support those in the cockpit. However, in what now is the US Air Force, the School of Aerospace Medicine has been preparing physicians for this challenge since before the 77-year-old Glenn was born and now is entering its ninth decade of doing so.

Almost as soon as aircraft became part of the military inventory, US Army and Navy (a separate US Air Force didn't exist until 1947) physicians realized that they must play a key role if humans were to fly safely. As early as February of 1912, the US Army ordered its medical officers to rigorously examine all aviation candidates.

But the aircraft accident mortality rate soared until, with the United States' involvement in World War I, 70% of pilot and aircraft losses were attributed to factors other than combat. So, as that war drew to a close 80 years ago, the US military offered its first course for medical officers who would be assigned to flying squadrons and be responsible for fliers' health and physical fitness. The first three graduates in 1918 were called flight surgeons, a designation still in use.

A military medical research board, created during the war "to investigate all conditions that affect the efficiency of pilots," established its laboratory on Long Island, New York. By the time the laboratory moved to Brooks Field near San Antonio, Tex, in 1926, it was called the School of Aviation Medicine.

The school later moved to neighboring Randolph Field and finally—with the backing for an aeromedical center by such key figures as Col Charles H. Roadman, MD, father of the current Air Force surgeon general, Lt Gen Charles H. Roadman II, MD—the school was returned to what today is Brooks Air Force Base. In the midst of all this, during World War II, some 500 research projects were completed.

With the end of World War II and the 1947 creation of a separate US Air Force, the school was supporting the space exploration effort. In 1961, it became the School of Aerospace Medicine. On November 21, 1963, the day before he was assassinated in Dallas, President John F. Kennedy dedicated expanded aeromedical facilities at the San Antonio site.

Today, John G. Jernigan, MD, a US Air Force brigadier general, commands the Human Systems Wing at Brooks, and Rodger D. Vanderbeek, MD, a colonel, is commander and dean of the School of Aerospace Medicine. As this program moves into its ninth decade, the school has departments of aerospace medicine, nursing, bioenvironmental engineering, physiology and human performance, and public health. Its mission is to "provide training, education, and consultation in direct support of the US Air Force, other Department of Defense agencies, and allied nations' aerospace operations . . . in the areas of human performance enhancement, occupational health, disease prevention, environmental quality, and aeromedical evacuation." Its aerospace medicine residency's third year is accredited as an occupational medicine practicum, the largest program of this type in the United States, and—in keeping with the US Air Force's ongoing reorganization into 10 deployment-ready units—the school is developing an "air expeditionary force" course emphasizing medical teamwork and preventive medicine in austere environments.

Its faculty conducts research on aircrew medical standards, protection, and performance enhancement; evaluates fitness for special assignments or return to flight duty after illness or injury; consults in a variety of areas from aircraft mishap investigation and prevention to hyperbaric medicine, food safety, and medical entomology; is developing new flexibility and strength fitness guidelines for US Air Force members; and has numerous other educational and research initiatives under way.

So, in a US Air Force that has been reduced from 607,000 to 371,000 men and women during the last decade, is called on to respond more rapidly over greater distances to a wider variety of humanitarian and peacekeeping demands, and flies more demanding aircraft, the School of Aerospace Medicine celebrates fourscore years challenged as never before to live up to its motto: "Volanti subvenimus—We support the flier."

Editor's Note: Miscellanea Medica normally appears in the Medical News & Perspectives section several times each month. Items submitted for consideration should be sent to Marsha F. Goldsmith, editor, Medical News & Perspectives.