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artificial kidney machine. It is also true that we might be unwise to sink all of our resources into this year's technology, when it is advancing rapidly. But meanwhile, there is a simple economic discrimination for the chance to live. Is this a problem chargeable to biological research? If we deal with it on the customary scale for basic research, the cost will inevitably be several hundred more lives than if we gambled a few hundred millions of incentive money to distract some mechanical engineering inventiveness into kidneys away from washing machines.
This does illustrate one of the main problems of health technology: low to provide economic incentive for a new industry, and how to relate Federal support on issues of human life and health to a body of talent which is now embedded in profit-oriented commerce.
It is too obvious to need mentioning that medical care is still not evenly available, that economic factors still dominate access to advanced technical skills in medicine—like psychiatry, nursing care, or batteries of laboratory tests. In the long run, skilled manpower is again the limiting factor in making the best of existing knowledge freely available, though better techniques could be developed to make more effective use of the scarcest kinds of people. The education of the patient population is also of the utmost importance in improving health, by evoking intelligent avoidance of quackery, and encouraging the use of preventive facilities when they are available-like prenatal care and survey screening for cervical cancer.
The discrepancy between existing scientific knowledge and its public availability and acceptance is immediately visible in attitudes on narcotics. The medical case against alcohol and tobacco is overwhelming, yet these agents are tolerated by the establishment. This might seem to reflect a principle that the law hesitates to intervene against determined self-abuse by legally competent adults, despite the enormous health problems raised by the easy availability of these commodities. But then the savage recriminations against marijuana are incomprehensible, except insofar as pronouncing any synonym of "hashish" is spitting in the face of organized society. This issue is somewhat remote from the consideration of social benefit of science. However, the failure of the law to follow pharmacological science and discriminate ca refully among different drugs in some relationship to their actual hazards is encouraging a defiance of the law in far more damaging ways, like taking on LSD and opiates. In general, the law on narcotics remains the despair of rational medical science, and is a testimony to the power of symbols of conformity. This is a controversial position, but there will be general agreement that social rather than scientific perplexities frustrate our dealing with the narcotics problem.
The situation is even more complicated where conflict of religious belief still enters into public policy. For a long time the importance of birth control for the health of the family has been universally conceded, but a militant religious minority nevertheless opposed the spread of the appropriate knowledge, and only grudgingly acquiesces in its availability now, even to members of other faiths. Since contraception has been practiced throughout this period by the whole middle class, the practical consequences of this perverse class discrimination have been to deepen the gulf between rich and poor, by class and by race. The administration has finally gathered the courage to insist on a
rational policy in furnishing birth control information, and we need not resuscitate settled controversies.
However, a similar conflict is following a similar course in the related field of therapeutic abortion. A scientific understanding of man is of the utmost importance for social policy here in several ways. Most important is the discovery of a number of catastrophes where the continuance of a pregnancy can be predicted to result in a deformed child, or in serious physiological or psychiatric injury to the mother. Then techniques for the safe interruption of pregnancy are now well established. Perhaps most important, biological science offers no support for the theological speculation that the fertilization of the human egg immediately results in a “human being”. On the one hand, the fertilized human
egg differs from that of an ape in a finite number of DNA components; on the other hand, any tissue of the human body, including cells of the menstrum regularly discarded by every woman, has in it the same hypothetical potential to participate in a developmental
cess. The egg does eventually develop into a human being, but only gradually does it become differentiated from the forms of other animals. By the time it is a viable infant, we have no doubt about enfolding it into the species, but every scientific observation shows his development to be a gradual elaboration of the potentialities ultimately inherent in every cell.
A Senate committee may be a strange place to defend a heresy, but if we are to ask honestly about the impediments to the utilization of scientific knowledge for human benefit, we must include these strictures despite their relationship to religious controversy. The consequence of a dogmatic position about therapeutic abortion is hardly to prevent the practice. Instead it has been forced underground, and perhaps a sixth of all pregnancies are now terminated illegally under conditions that are a serious medical and psychological hazard to a million women every year! Judging from trends around the world, however, we may hope for a gradual transition of authority in this area from the penal code to private morality where it has a place I would not presume to intrude upon. Our political problem is how to respect the conflicting passions intensely held by different groups of constituents, giving the utmost latitude to individual liberty where it does not intrude on the welfare of the whole group.
The questions I have just discussed are remote from the immediate legislative responsibilities of this committee, but they help to illustrate the complexities of applying merely scientific attitudes to human problems. The allocation of resources is likely to remain subject to the same complexities.
The fruits of biomedical investigation are more importantly medical molecules than even the elegant medical machines like the artificial kidney. It would be highly desirable to subject the whole process of drug research to an optional systems analysis and attempt to rationalize it once and for all. Under the impact of Federal support for research in medical schools, and an aggressively defensive patent policy connected to that support, fundamental biochemical research is becoming less and less effectively coupled to the actual development of useful drugs in the pharmaceutical industry. Indeed, with more effective regulation of drugs, and appropriate demands for more rigorous testing, and with legislative interest in drug pricing, there is serious danger that risk capital for drug development will be choked off, that a larger and larger proportion of capital investment in that industry will be devoted to the promotion of existing agents, the few that have passed the scrutiny of an agency pressed to assure the impossible goals of absolute security and perfect efficacy. Promotion versus research is also encouraged by the growing bewilderment of an overbusy medical profession unable to sustain its own education for discriminating criticism of new drugs, and therefore increasingly reliant on the drug industry's slick ads and detailmen for its own expertise
. Here, the ultimate problem is the inability of the medical profession to keep faith with the demands of the times. By failing to maintain its own capacity to judge the merits of new agents, it has abdicated its responsibility to a Federal agency that inevitably must follow the most cumbersome procedures toward monolithic judgments about their safety and efficacy. In the process, a great deal of flexibility is lost; only those drugs can be allowed even on the ethical market which are safe for the average practitioner who is assumed to be guided by the fine-print disclaimers and precautions in the manufacturer's literature. To the extent that only an enlightened minority of the pretising physicians remain in contact with modern medicine through systematic postgraduate training, the profession as a whole will remain at the mercy of self-interested advertising, which in turn does have 10 be policed by a regulatory bureaucracy. The profession itself must accept the responsibility of qualifying its membership: the Government could, however, accelerate this process by recognizing a gradation of responsibility that can be assumed by practitioners with more sophisticated training—a result toward which the roster of qualified drug experimenters is a useful step.
The expertise of the medical profession is, however, so vital to our national well-being that we should also begin to consider more farreaching measures. The most essential is the reinvigoration of our centers of medical education to encourage the training of many more physicians over a wider variety of skills and specialties. Some of these centers must also be dedicated to the continuing education of mature physicians, being training and information centers for the latest advances. We have modern techniques of dissemination at our fingertips—wideband communications, computerized information retrieval videotape libraries—but we have not yet learned to apply them to this vital use, more out of perplexities of economic polier than because of technical limitations. One of the fundamentai difficulties is that the time of the mature physician is so valuable he can hardly afford even his present efforts at continued self-education. The organized profession's tacit attitude in its public representation that every physician is equally and identically perfect offers the most limited encouragement to his self-improvement. It should be possible to devise tax incentives or even more direct subventions to encourge a more positive trend. Consider, for example, the career scholarship proposal. A meritorious fraction of medical students should be offered full scholarships covering their own living expenses and the cost of their education throughout their initial training period usually at least 7 years after the college degree. These scholarships would, however, be loans rather than gifts: The regular means of repayment woull be not in cash but in credits from (1) later national or community-oriented
service, (2) regular intervals of postgraduate education, the credits partly compensating for the time taken from their practice, or (3) time spent in clinical teaching, as is now generously volunteered by many of our finest specialists. If the prorated cost of education where included in the stipend, the system would already provide a big step to funding the needed expansion of medical education, and the students themselves would constitute a very broad selection committee for allocation of support to beneficiary institutions. Such a program is undoubtedly self-liquidating in terms of the tax yield from improved earnings, but even if it were not, the social interest even exceeds the personal interest of the physician in his own continued education.
Analogous approaches are worth considering to encourage the most creative deployment of the resources of the drug industry. In view of the restraints on profiteering on drugs, secondary incentives for risking capital in research are essential. The operations of FDA ought to be financed by a manufacturer's excise tax on drugs amounting to, say, 25 percent of their wholesale value, or about 10 percent of the consumer price. However, the company's research and testing costs (its investment in innovation) should be credits against that tax. Furthermore, companies that contribute matching funds to university research should be franchised to be able to participate fairly in patents in which the Government now would retain a preclusive interest, and even worse, a vaguely defined bureaucratic involvement. The lack of clear definitions of the scope of government interest in patents that bear any relationship whatsoever to Federal health research support is an intolerable bar to industrial-academic cooperation. Perhaps we might bar patents altogether for the more fndamental aspects of drug innovations, and leave them only to the fruits of the later, costlier development work for which industry is better suited. For example, a drug might be patentable only at the stage where it could qualify for FDA approval, the company being allowed some period of time after preliminary registration during which to pursue the development work, the registration itself entailing a substantial commitment of effort.
Every possible measure should be considered to minimize the commerical value of a brand name, which is generated by the huckstering of the medical profession, in favor of the actual merit of the innovation in the drug itself. Another way to approach this is to relax the law that requires a prescription to be filled by the brand-specified product, so as to encourage the use of generic names. Physicians must, however, be left the discretion to specify a particular formulation and manufacturer.
In sum, we need to reconstruct the whole system of therapeutic innovation so that the drug companies are encouraged to reinvest in research and development, and so that the medical profession is kept in life-long contact with disinterested centers of medical education.
Fundamental biological research has made the most extraordinary advances within the last decade, especially in the elucidation of the genetic material, DNA, and the chain of events that links this to the synthesis of the proteins from which cells are made. This solid basis for biology is a credit to a cadre of fundamental scientists who function as teachers as well as researchers. Their domain of teaching includes the undergraduate who matures into our informed citizen, and also their own graduate students who will continue the traditions of
fundamental research. It also includes the applied biologists, the physicians who need a sound perspective on human biology to pursue their art by the highest contemporary standards of skill and science. Outside the classroom, basic research also teaches all of us the reality of an elusive nature that will give its secrets to no wishful hopes, but only to hard work, ingenious intellect, rigorous measurement, and dispassionate analysis.
The rapid extrapolation of these research findings to human problems requires a superstructure of which we have only the barest framework. Clinical research on human beings is incredibly slower and more expensive than comparable work on microbes and laboratory animals. It is also fraught with grave moral problems. Whenever any one of us gets effective medical treatment, we benefit from the risks, inconveniences, and sacrifices of others who have participated in the clinical trials to prove the efficacy of that treatment. How do we measure our responsibility to others to help in this process? But the most stringent bottleneck at present is in trained people—the very clinicians who might be best able to do this kind of research are the busiest people in the community, working overtime in the care of patients. If we are to get good clinical research, they need relief-which means financial support for our medical schools to hire two in place of one person to do the work of three, and a new look at the manpower goals of and recruitment for medical education, which is still the stepchild of federally supported graduate training programs.
Besides the manpower shortage in clinical research, this field suffers from serious difficulties in the collection of data on the life histories of human beings. For example, in 1955, at least 4 million children were inadvertently inoculated with a virus, SV-40, that contaminated some polio vaccines. Subsequent studies on the geographic incidence of various diseases have shown no relationship to the distribution of SV-40 exposure, and we can possibly breathe a sigh of relief that this was not the worst medical catastrophe of modern times. However, our health data management is so bad that it would be almost hopeless to correlate individual cases of future disease with past exposure to this virus. We are confined to rather general comparisons of time and geographic trends, which would be quite insufficient to detect risks which, while far short of catastrophic, would generate considerable alarm if attached to other drugs. The same concern attaches to other drugs in wide use. For example, the oral contraceptives as a group have been exonerated from any acute, substantial risks-compared for example to the hazards attached to the normal pregnancies they are intended to avert. It is very difficult to evaluate very low level, long-term hazards--or for that matter, incidental benefits—with our existing techniques of population study. A number of different agents and dosage forms are already on the market, and over a 10-year period it will be quite useless to get reliable information on exposure history by retrospective interrogation of a woman who may turn up with some or other disease which might or might not be within the range of average expectation. Situations like these cry out for definitive registration, but there would be a justifiable outery of potential invasion of privacy if data like contraceptive prescriptions were centralized. Yet there is an outstanding social need for such information on a large scale. The concept of the