Nelson et al. of the University of Michigan published an article titled: Pathologic Evaluation of Routine Pediatric Tonsillectomy Specimens Analysis of Cost-Effectiveness in the journal Otolaryngology–Head and Neck Surgery. Their abstract follows:
Objective. Evaluate the utility and explore the cost-effectiveness of mandatory gross or pathologic analysis of routine tonsillectomy specimens in children.
Study Design. Case series with chart review.
Setting. Tertiary care children’s hospital.
Subjects and Methods. Retrospective case series of results of pathologic analysis of tonsillectomy specimens from all pediatric patients who underwent tonsillectomy between 1996 and 2008 (n = 5235). The results of pathologic evaluation of routine and nonroutine specimens were evaluated, and an economic analysis of alternative methods of specimen handling was performed.
Results. Zero cases of unsuspected pathology were identified on planned gross specimen evaluation (n = 4186), resulting in an estimated prevalence of 0 to 0.00088 (95% confidence interval [CI]). Positive pathologic findings on microscopic analysis (n = 1066) were only identified in posttransplant patients (10/63; 95% CI, 0.079-0.27) and cases of surgeon suspicion (8/78; 0.045-0.19). No cases were identified among the 17 undergoing microscopic pathologic analysis on the basis of pathologist suspicion on gross evaluation (95% CI, 0-0.20). From an economic standpoint, microscopic evaluation of routine pediatric tonsillectomy specimens appears to be superior to gross evaluation but with an estimated cost of $766 500 per case of unsuspected lymphoma identified.
Conclusions. This study identifies a very low prevalence of unsuspected pathology on gross pathologic analysis of routine tonsillectomy specimens in children. Exploration of the cost implications suggests that such a practice is not a cost-effective use of limited health care resources. Microscopic examination is appropriate for posttransplantation patients and in cases of surgeon suspicion.
Basically, the above says that examining tonsils, taken out during surgery for tonsillectomy, under a microscope or even an eyeball-only exam (called a gross exam) by a pathologist is not cost effective. In this study, no diseases were diagnosed this way and all the diseases that were diagnosed by the pathologist were diagnosed because the surgeon was suspicious something was wrong with the tonsils before surgery or became suspicious during surgery. In other words, society could probably skip routinely sending tonsils to the pathologist and save some money in health costs.
(I should here say that it is not the purpose of this blog to comment on whether society should take this step. What questions like this usually boil down to is whether you want to pay the extra money for, say a path report, even though the likelihood of your otherwise healthy child having something bad wrong with him, that can only be diagnosed by said pathologist, is probably around one in a million or thereabouts. If I were the patient, I would say skip it (I actually have done that) but others would disagree. Hence the controversy. For more see the article (link above) or this press release.)
The reason I am writing about this is that it is a good example of where research funding should be going. People always ask: “What will we do if we don’t experiment on animals?” (We wrote a book by that title so for a more complete answer see the book.) But this article is a good example of research that needs to be performed and that, historically, has been severely underfunded. In the final analysis you want your physician to know what to do when you need medical intervention. She is not going to figure that out by studying animals. Clinical research like the above is responsible for how we physicians actually treat patients. Many therapies have been shown to cause more harm than good in studies like this and hence were abandoned. Likewise, interventions and tests were proven effective in studies like this and we now use them daily. But much of what physicians do everyday remains unstudied.
Given the importance of such research, you would think it would receive most of the NIH research funding. But you would be wrong. Ahrens:
By far the largest percentage of NIH support for new R01’s… is awarded to applicants for studies of animal (or microbial) models of human disease. Yet, most experienced investigators realize that animal models of arteriosclerosis, diabetes, hypertension, and cancer are different in important ways from the human condition they are intended to simulate.” (Ahrens 1992)
Between 1977 and 1987 only 7.4 per cent of the NIH’s R01 funding went to basic patient-oriented research. (Ahrens 1992)
In 1988, the president of the Institute of Medicine (IOM) cautioned that medical research was leaning too heavily on basic animal experiments and not enough toward clinical observation. He called it an “emperor has no clothes” scenario. (Smith 1988) An IOM survey revealed that NIH gave only 15-17% of total grant money from 1990-1991 to research that could be regarded as human clinical research. This included research with human cells and tissues. Only 4.5% went to lab research involving humans. (Marshall 1994) In 1993, the National Cancer Advisory Board declared that clinical research was in “crisis.” The next year the National Cancer Institute (NCI), a division of NIH, allocated only 1% of its total R01 funds to clinical research. (No Authors Listed 1996)
Another reason clinical research is underfunded is that it is hard and people would rather get the easier money for the easier animal-based research. Judith Vaitukaitis of NIH: “Nothing is more demanding, more difficult, more frustrating, more time-consuming, and requiring more creativity than clinical research . . . The NIH under-funds patient-oriented clinical research.” (Vaitukaitis 1991)
Vivisection activists will tell you that using animals is but one way of conducting research and that they have no issues with clinical research; indeed they support it. This is a half-truth at best. When funding cuts are required they are not so collegial. Susan Fitzpatrick of the James S. McDonnell Foundation wrote a letter published in The Scientist in January 2011, in which she stated:
I earn my living thinking about science funding, and I have tried to draw attention to the detrimental warping the current system exerts on academic norms and values. More than a decade ago, I floated an idea akin to the one in this Opinion by many of my friends and colleagues, mostly successful biomedical researchers at prestigious research universities who are well-funded by NIH. Many think it a good idea as long as the “everyone has enough but no one is huge or overly rich” rubric is only applied to others. Whining for dollars is the #1 academic indoor sport, and no one does it better than biomedical researchers! The roots of this problem deserve serious outing: overbuilding, the addiction to discretionary funds brought to institutions via indirect cost recovery, and the overproduction of trainees. A smaller, leaner basic biomedical enterprise, unfettered and allowed to study serious biology, will probably accomplish much more than the bloated work-fare program we currently are trapped in. (Fitzpatrick 2011) (Emphasis added.)
Society, as individuals and through Congress, needs to examine what works and what does not in medical research and fund that which has a track record of successfully improving patient care.
Ahrens, EH. 1992. The Crisis in Clinical Research: Overcoming Institutional Obstacles. New York: Oxford University Press.
Marshall, E. 1994. Does NIH shortchange clinicians? Science (5168):20-21.
No Authors Listed. 1996. Funding for clinical (patient-oriented) oncology research: current status and recommendations for improvement. American Society of Clinical Oncology. J Clin Oncol. 14 (2):666-70.
Smith, Richard. 1988. News. From the Royal Society's meeting on the funding of science BMJ 297 (6657):1149-1154.
Vaitukaitis, J. L. 1991. The future of clinical research. Clin Res 39 (2):145-56.