“It Isn’t Always Fun.” – High-tech Medicine
“Science finds, Industry applies, Man conforms.”
Motto of the 1933 Chicago World’s Fair
It seems that the Chicago World’s Fair motto of my boyhood has come true. How, in fact, are decisions made for medical research and development (R and D) in this country today?
Thinking people everywhere support medical progress in healing, in prevention of disease, and in promotion of long and healthy lives. Most also support a free enterprise approach that spurs such progress. But let’s examine the process and priorities of high-tech development within the medical-industrial complex that has become such a major socioeconomic force in America.
Classic assumptions that underlie a sustainable laissez-faire policy, including a free market for medical R and D, include: a) that there is no monopoly and b) that the customer knows the value of what is being bought. Is either of these requisites met in the current medical-industrial system?
In fact, people today have poor knowledge and little choice about public funding of R and D or about their medical product. There is largely a monopoly or oligopoly in which people have no role in the decisions that determine R and D or the medical marketplace. Eventually, such a rampant laissez-faire process results in a distortion of priorities and resources.
If this is true, is it possible to bring a more thoughtful and open democratic process into decisions, for example, about high-tech research and development that drives the system, determines the market, inflates costs, and consumes resources? Are there, for example, alternatives to the existing scientific review process and other social, political, or regulatory choices for medicine?
Background of the Issue
We marvel at the contributions of high-tech medicine to the dramatic salvage of individual lives and the opening of uncharted seas in medical care. We recognize that medicine is poised for major developments in genetics and microbiology, in organ replacement, and in high-tech enhancement of diagnosis and therapy. Each of us wants and expects the fruits of these advances when we and our families are stricken.
But the overall strategy of high-tech R and D, that is, laissez-faire, and its direction mainly at repair or replacement or end-stage disease, is importantly driving the system.
Consider the phenomenon run wild a few years back in the offer by one hospital of the total implantable artificial heart technology as a bald marketing bid to attract physician referrals and patient self-referrals to its doors. That was an isolated, small decision by a small institution. A much larger and more profound development was the speedy approval and launching of the multi-billion-dollar, government-run Human Genome Project, important as it was and is, but having been accorded minimal scientific debate and virtually no thoughtful consideration by the public.
At some point the public may come to demand change in this entirely laissez-faire process and insist on more participation in decisions to develop or not develop ever more new, high-tech, expensive medical applications. But first, we need to understand how decisions are actually made in the pursuit of medical innovations.
R and D Laissez-faire
At the outset, the motivation to high-tech medical “solutions” goes something like this:
• the philosophical base is laissez-faire — acceptance and a priori justification of “pure research for the sake of pure research,” “seeking truth for the sake of truth,” “saving lives for the sake of saving lives,” and “progress for the sake of progress.” In this view, all research, all high-tech development, is integral to academic freedom, the near-divine right of an investigator to pursue any and all research and its associated technical enterprise (we will touch later on the flimsy checks and balances given by peer review).
• the operational strategy, too, is laissez-faire, the main task being to determine whether the particular high-tech gizmo can be made at all and actually works. The first goal of this free-market non-plan is to build and test a prototype device or product. The ethical reconciliation in laissez-faire is left to faith that, following a technological success (preferably a “breakthrough”), society can then decide responsibly whether the gizmo should go into production and then be marketed.
Within this comfortable philosophy and easy operational strategy, novel ideas are indeed stimulated and often brilliantly engineered. One party, usually the principal medical investigator, prepares a proposal and applies for support to pursue the high-tech innovation/solution, directed usually to the Division of Research Grants (DRG) of NIH. The proposal most often deals with a real and present health problem that may or may not be a public health problem in terms of frequency of illness, disability or death. The DRG of NIH refers the proposal to a standing or ad hoc study section of peers and experts, most often an ‘ol’ boys and girls club’ of colleagues from the PI’s own specialty field. Staffs of the appropriate Institute are assigned to make a parallel review of project compatibility with Institute policy, interests, budget, and priorities.
In an otherwise competent and effective scientific peer review process, only scientific, technical, and cost elements are considered. Cursory attention is required to special issues of geographic representation and ethnic mix of the subjects, informed consent and privacy of health information, and proper treatment of laboratory animals. Rarely is any wider sociocultural, economic, or ecologic implication of the proposal addressed at this critical early stage of review and approval.
If the review process should result in no funding, due to a low scientific score or incompatibility of the proposal with NIH “program priorities,” other more sinister developments may arise. Industry or political interests, thwarted in the prestigious NIH review process, may respond in more accustomed business strategies to influence the course of a project and thus by-pass NIH peer review. Congress may even be lobbied directly. Home-based political or economic capital attached to a proposal can result in direct pressure from Congressional offices on the NIH, or in specific sponsored legislation. Scientific review is thereby politicized. The consuming public is left entirely out of the loop.
Even in “proper” operation of peer review, the process is flawed. When, for example, the high-tech prototype is approved and built, society is denied the dispassionate evaluation of its social impact. In fact, production and marketing beyond the prototype are assured because much energy is already invested. Clearly the investigators have not come so far to let their prototype gismo crash. NIH staff and a growing new empire around the development are already strongly identified with the project. Special NIH sections and careers are already integrally involved and committed to the new high-tech widget. Subcontracts may have been let for further R and D to supply the power, pumps, and electronics for the gismo. Investors who early committed venture capital now stand in the wings. Profitable returns are anticipated. Reputations and careers, as well as resources, are on the line.
Are any of these players able or willing at any stage of this development to make a dispassionate evaluation of the need for or the chances and costs of successful application of the new device or product? Rather, are not all parties driven to seek ever more support for the widget, toward the hoped-for payoff? In my experience, resource investment and social return never rise to any conscious level of consideration in this process. True costs and benefits are rarely analytically projected. Broader social need, effects on the ecology, and social priority are simply not entered into consideration, nor will it be studied, even estimated, who is truly served by the new development and at what ages and to what ends. Never considered are comparative costs and benefits of the high-tech dealing with emergent or end-stage disease in comparison with preventive approaches shown to benefit large numbers and to save money and lives. The “unassignable value” of an individual human life, that special legacy of western values, was accepted as our guide long before expensive high-tech “cures” came along.
I propose that society needs better mechanisms to address the social, economic, and ethical issues surrounding major high-tech developments and to address them early, before a large public investment is made in careers, empires, prototypes, and production. As the review process becomes more politicized, such as probably happened with the Human Genome Project, and as I know from direct involvement happened with the totally implantable artificial heart, it is appropriate and desirable that review become a more comprehensive and open process. Should it require objective guidelines, based on broad and agreed social values such as relief of suffering and reduced cost for substantial numbers of people, to justify significant public funding of high-tech R and D? I’m not sure, but I would like it discussed at high levels and low.
In practice, the review system operates perversely, quite at the opposite extreme of the social issues. Huge resources are given to develop, for example, costly artificial organs or other approaches to prolong life, often for a matter of weeks and under dangerous conditions of poor life quality and ultimately intended for a handful of people. A classic argument has gone on for a quarter century pitting the totally implantable artificial heart (TIAH), its prototype under development by rival government enterprises (NIH and NASA), against a simpler, safer, and less costly ventricular assist device that tides a patient over until the ultimate high-tech procedure, cardiac transplant, is available.
Occasionally in our enterprising society appropriate decisions are made to avoid or interrupt a high-tech development. I divert for a moment to a related personal anecdote about R and D for the TIAH:
In the mid 1970s, I was appointed to the advisory panel of the Cardiology Branch of NHLBI, an “independent body” of physicians, surgeons, engineers, and business people. After two days hearings on the above issue of the Totally Implantable Artificial Heart, I suggested there was a parallel to the competitive, costly, high-tech development of the commercial supersonic air transport, SST, which had just undergone public review of its broader implications. Miraculously, the Nixon administration finally concluded that implementation could not be further influenced if the U.S. flying prototype were developed. So it simply canceled the prototype. [The 40-year history of the British-French Concorde speaks volumes in favor of that early U.S. administrative decision. Less than full-scale pursuit of Star Wars technology under Reagan and Bush #1 was comparable. Bush #2, it seems, moves ahead, Full Monty, without public debate on Star Wars.]
My SST analogy to the TIAH was met with stunned silence in the Cardiology Advisory Council. At its very next meeting three months later, on the second day, its chairman announced in the morning that all were cordially invited to cocktails to commemorate the rotation of Dr. Blackburn off the committee. At the morning break, puzzled, I called my secretary in Minnesota and asked that she confirm from correspondence my vague recollection that my appointment to the Council was for three years. Indeed, I was being “rotated off” two years prematurely!
Following my pensive musings about the SST, the horrified surgeons, engineers, and industry representatives on Council became proactive and got to the chairman and to NIH staff to get that guy Blackburn out. Stop R and D on the artificial heart before the prototype even exists? Such ideas!
Many years and millions later, after thorough reconsideration and debate, NHLBI canceled its support of the Totally Implantable Artificial Heart in favor of the Ventricular Assist Device. Then the Wrath of God, in the form of Senator Ted Kennedy and his constituency among the Massachusetts Medical-Industrial Complex, came down in a lightning bolt on the head of NHLBI director, Claude Lenfant. Still the old game goes on: “Science finds, Industry applies, and Man conforms.”
Ethics, Priorities, and Cost/Benefit
The relative cost/benefit and ethics and ecological soundness of preventive programs compared to high-tech “curative” medicine have never been seriously debated in the U.S. From mobile MRI scanners to International Space Station experiments, the medical-industrial complex, operating in the free market, goes on to produce both marvels and monsters. The community, unable to discern the difference, seems to accept and value both equally.
I pose the tentative view that decisions on such medical R and D need to be made well before production of the prototype, because, once it is developed, careers and investments are so committed, and conflicts of interest are so ingrained and severe that all opportunity is lost for dispassionate evaluation of true need, scope, impact, cost, and ethics of the whole undertaking. Mere existence of the widget is sufficient rationale for its continued existence and promulgation.
Less tentatively, I suggest that the socio-cultural, economic and ethical evaluations be carried out at least concurrently with scientific review and prior to full go-ahead on major high-tech and prototype development. Few now doubt that the 1970s decision on the American commercial SST was wise. It appears to have been made on sound and rational grounds and after appropriate consultative deliberation.
Of course, a societal decision to eschew a particular high-tech solution, made at one time, need not be irrevocable. With new power sources we may one day replace the grounded Concorde. Nevertheless, citizens should have the opportunity to participate in the decisions before large investments are made of public monies and rational decisions become no longer possible. Perhaps we need to recognize, with the clarity lost since Dwight Eisenhower’s early warning about the military-industrial complex (which nowadays drives our national and foreign policy with greater direction than ever before), that the medical-industrial complex drives with equal force the medical research and health care systems of today. R and D decisions are currently based only on projections of scientific feasibility, narrow special interests, and potential economic profit, with little or no consideration of social ethics or ecologic impact.
A new R and D process might include essential review elements now missing; for example, early involvement of distinguished lay persons, respected community leaders outside the “old-boy network” and outside science. A few such folks now sit on NIH Advisory Councils but they are the end-station or court of last resort of peer review. These advisers presumably would be committed to free enterprise in science but would bring sound philosophy and ethics and social awareness on one hand and credibility in ecology and the wise use of resources on the other, to set the framework and guide the scientific review process.
Other options are not immediately obvious to involve broader social considerations in the review process for costly high-tech innovations. They would be modeled, of course, on the strengths of the existing NIH review process, which, though flawed like American democracy, is, nevertheless, the best there is.