December 2017 Edition. Volume XVII

The following is a article published by the Editor in 1977 in the Journal NEUROSURGERY.  The conclusions drawn previously remain appropriate for the present time.

The Balance between Regulation and Freedom

Charles V. Burton, M.D. Minneapolis, Minnesota

Since 1974, when the Food and Drug Administration (FDA) Advisory Panel on Neurologic Devices was first formed, the author has had the privilege of chairing this committee. This position has provided a particularly good opportunity to review the regulatory process of the Federal Government in action as it is directed towards medicine.

We exist in a society governed by law, and there is a natural tendency to focus attention on the laws themselves. The rather remarkable thing is that laws are often irrelevant. It is the interpretation and application of these laws that are the significant factors. Not only do these processes sometimes bear no relationship whatsoever to the laws themselves or to the intent of the Congress that created them, but there are many cases in which interpretation and application may actually be at significant variance with the legislation, evident only to the few willing and able to read and understand the foreign language of “legalese.”

We now live in an era characterized by increasing governmental intervention in the practice of medicine. It is well recognized that, with increased regulation, there is invariably decreased innovation and an associated decrease in the quality of health care. The significance of this cannot be fully appreciated until our health care system is compared to those of other countries. If this is done, it becomes evident that one of our basic advantages is that of advanced medical technology. This does not relate to superior intellectual ability; it appears to relate to the opportunity of entry afforded to the innovative mind and the motivation to produce offered by a free enterprise, competitive system (1). The opportunity to innovate and the associated serendipity are the very bases upon which American medicine has made such giant strides in the past decade alone. With the progression of drug and device legislation and associated regulation, combined with the increased cost to drug and device manufacturers of legal assistance in coping with these, ever increasing product liability insurance costs, and the now proposed hospital cost containment legislation, it is not surprising that we seem to be on a course of self immolation. The situation was succinctly described by Walt Kelly in his comic strip Pogo, “We have met the enemy and they are us.”

Even those physicians who have taken the time to try to understand and contribute expert advice to the problem are no match for the full time professionals in Washington. Also, one wonders whether those congressmen who were key in formulating health care legislation have any control over interpretation and application. In cases in which congressmen responsible for legislation complained that resulting regulations were “illegal” because the interpretation of the law was not based on congressional intent, they were refuted by the courts (reported in the “Devices and Diagnostics Letter,” Vol. 4, No. 23, June 10, 1977, published at 1080 National Press Building, Washington, District of Columbia 20045). Courts have held that post enactment correspondence from members of Congress does not serve as “proof of congressional intent.” Who then in our government can provide this?

Consistently, laws have been passed placing bans on the delivery of health care in ill considered attempts to protect the public welfare. In 1962, the Kefauver-Harris Amendment to the Food, Drug and Cosmestic Act of 1932 added the consideration of “efficacy” to our food and drug laws. This has come home to roost in many issues. Why ban anything that is safe? The determination of efficacy is a modern reincarnation of the Mad Hatter’s tea party. What is efficacy? If present federal efficacy considerations, being applied to new drugs and devices were applied to all presently accepted modes of therapy, there would certainly be a bit of a revolution (e.g., the surgical management of glioblastoma multiforme). Safety is a reasonable parameter; efficacy is not because of the difficulty in even defining it. Another inappropriate ban, now in the public view because of saccharin, is the 1958 Delaney Amendment to the food and drug laws, which states: “No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal. . . . ” Once again, an absolute ban exists, which allows no room for risk-benefit judgments, the key upon which good medical treatment depends. What may be unsafe for the majority of patients may still be the treatment of choice for an individual patient.

The regulators are willing to define the “thou shall’s” and “thou shall not’s” of medical practice. Unfortunately, organized medicine is not equally as well motivated to fulfill this function. Device and drug manufacturers are now fulfilling it for us. Have you read any product inserts lately? This was previously considered “advertising” by the FDA (2). No longer. Deviation from a manufacturer’s recommendations now constitutes prima facie evidence of negligence in some states (3). Where does neurosurgery fit into this? In actuality, organized neurosurgery has probably made one of the greatest medical efforts to provide expert advisory service and to work with the Congress and federal agencies. Unfortunately, this effort is miniscule when compared to the constantly advancing behemoth of regulation and control. Yet, neurosurgery has brought regulatory agencies into the neurosurgical thought processes in many areas. The Neurologic Advisory Panel of the Food and Drug Administration has recently held scientific reviews with invited neurosurgeons providing testimony in the areas of cranial electrotherapeutics, trans-cutaneous electrical nerve stimulation, tissue adhesives, cerebellar stimulation, aneurysm clips, sonic bone instruments, computerized tomographic systems, and shunts. FDA-sup-ported scientific studies and literature studies are presently ongoing in the areas of biocompatability, implants, and aneurysm clips. In addition, there have been cooperative symposia and publications. By maintaining communication, it appears that, in many cases, expert advice has allowed governmental decisions to better reflect actions productive for the public welfare.

In all fairness, government agencies themselves are under pressures from many directions, some of which are unreasonable. In 1976, a Congressional committee chaired by Rep. Peter Fountain strongly criticized the FDA for being “lenient” toward industry and allowing potential “conflict of interest” to exist on advisory panels. Subsequent recommendations have created a “Monday night massacre” elimination of many panel chairmen and members within the past year. The present disclosure requests for potential panel members are so comprehensive and the conflict of interest requirements are so stringent that it is practically assured that only those persons with little knowledge of the subject will be confirmed as government consultants. It would be far more reasonable not to exclude knowledgeable professionals, but to document carefully any potential conflict of interest and to make this information public. Under a “sunshine” approach, expertise can be utilized, but also placed in proper perspective. At this time, there is great difficulty in finding qualified neurosurgeons who can “survive” the present clearance process. Those who make it must go to great lengths to divest themselves of investments and affiliations.

The balance between regulation and freedom is progressively tipping in favor of regulation. It would be unrealistic to expect that this will change in the near future. Under the circumstances, it appears that organized neurosurgery is presently doing everything it can, with limited resources, to control its destiny.

References:

1. Burton, C., and Gardner, R. M. Biomedical
instrumentation in the Soviet Union. Med. Instrum. 11:124-126, 1977.

2. Fredman, S., and Burger, R. E. Forbidden Cures.
New York, Stein and Day, 1976.

3. Stevens. H. Medical legal aspects of clinical
monitoring. Ann. Clin. Lab. Sci., 6:440-445, 1976.

NEUROSURGERY, Copyright © 1977 by the Congress of Neurological Surgeons Vol. 1, No. 3, 1977

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