A
to the editor in this issue of The Journal F. Hamit, MD, reiterates some obserHarold (p 226), have I made about the package literature of vations it drugs1-7: often fails to reflect best current prescribing standards. Yet Dr. Hamit reminds us that despite this failing of many package inserts, a physician may incur some legal risk if he fails to adhere to their strictures. I assume Dr. Hamit is thinking of the possibility of malpractice liability. I hope that my previous publications2,3,5,6 and those of other authors have dispelled the vague notion that physicians may somehow violate some federal law if they depart from the recommendations of package literature. Nothing in the Federal Food, Drug, and Cosmetic Act supports this erroneous belief; spokesmen for the Food and Drug Administration (FDA), the agency that enforces the Act, have repeatedly acknowledged this fact. Best medicine often requires that a physician depart from package insert recommendations. Naturally, such de¬ parture should be based on solid scientific evidence and sound judgment. Even in this circumstance, however, a disagreeable reality must be recognized: a physician who deviates from a manufacturer's recommendations in pre¬ scribing a drug may be confronted by that literature in court if something goes wrong. Of course, such literature is subject to rebuttal. Nevertheless, if all goes well at the trial, the competent and exonerated physician has still been subjected to a harrowing and grotesque experience. That fact leads to a decision that must often be made in the practice of medicine. Physicians must squarely acknowledge certain alternatives. One is to practice defensive medicine, never varying from package insert recommendations, rec¬ ognizing that sometimes this will deprive patients of opti¬ mum care, but hoping that it may diminish a degree of litigation risk. The other is to use drugs according to the carefully determined medical need for them—and if harm unfortunately is attributed to some unlabeled use, to as¬ sume or at least to hope that the case will be tried prop¬ erly—that insofar as the package insert becomes involved, it will be considered in the light of how well it reflects prescribing standards and not in the sense that it sets them. A major purpose of "A Guide into Chaos"1 was to illustrate how absurd is the notion that labeling can legiti¬ mately set standards. A great danger is this: if the medical profession ever comes to believe such a notion, the courts may come to accept the belief. To his credit, Hamit evidently rejects the belief. It is also interesting that Lasagna and Wardell8 have noted
In
a
letter
Address editorial communications to the
the FDA approved labeling recommending for angina pectoris, "some cardiologists came to consider a recommendation for coronary artery surgery without a trial of propranolol a form of malpractice." John D. Archer, MD
before propranolol that
Vexing Decision
Editor, 535 N Dearborn St, Chicago,
Senior Editor
1. Archer
1974. 2. Archer
JD: A guide into chaos: Resist it. JAMA 227:1397-1388,
JD, Kosman ME: Propranolol
controversy.
JAMA 227:201\x=req-\
202, 1974.
JD: Methylpredisolone for sunburn, FDA and package innotwithstanding. JAMA 225:72, 1973. 4. Hussey HH, Archer JD: Propranolol and labeling. Ann Intern Med 79:608, 1973. 5. Archer JD: Instrument or impediment? The regulatory monograph in medical communications. JAMA 220:1474-1477, 1972. 6. Investigational exemption procedures for new drugs, AMA Department of Drugs. JAMA 213:1902-1904, 1970. 7. Package inserts of drugs\p=m-\relatedproblems, AMA Department of Drugs. JAMA 194:187-189, 1965. 8. Lasagna L, Wardell WM: The FDA, politics, and the public. JAMA 232:141-142, 1975. 3. Archer
sert
When is
Tonsillectomy Indicated?
There is hardly any area in which we have more experience and less knowledge than the physiology and pathology of the lymphoid tissue of the throat. We still do not know enough about the functions of the tissue that constitutes the Waldeyer ring, the influence of infections of this tissue on the patient's general health, and the role of tonsillectomy and adenoidectomy in prevention of rheumatic fever. More than two years ago, the American Council on Otolaryngology formed an Ad Hoc Committee on Tonsillectomy and Adenoidectomy, in an attempt to define clear indications for these procedures. The committee consisted of 11 outstanding scientists under the chairmanship of Charles D. Bluestone, MD, professor of otolaryngology at the University of Pittsburgh School of Medicine. The committee suggested that investigations be undertaken in epidemiology, pathogenesis, and pathophysiology of tonsillitis and adenoidal hypertrophy. Under a grant of the National Institute of Neurological Diseases and Stroke, a workshop on tonsillectomy and adenoidectomy was convened June 12 through 14, 1974, at West Newton, Mass. It was again chaired by Dr. Bluestone; 27 outstanding scientists in otolaryngology and related dis¬ ciplines participated. The scientific papers read at the work¬ shop were published this spring; they cover a wide range of topics including the relation of tonsillar pathology to res¬ piratory, cardiovascular, and otological systems. The participants of the workshop, however, found that an
additional,
more
prospective study IL 60610
Downloaded From: http://jama.jamanetwork.com/ by a University of Manitoba User on 06/19/2015
extensive, nationwide collaborative
is needed of the effects of
tonsillectomy
to the editor in this issue of The Journal F. Hamit, MD, reiterates some obserHarold (p 226), have I made about the package literature of vations it drugs1-7: often fails to reflect best current prescribing standards. Yet Dr. Hamit reminds us that despite this failing of many package inserts, a physician may incur some legal risk if he fails to adhere to their strictures. I assume Dr. Hamit is thinking of the possibility of malpractice liability. I hope that my previous publications2,3,5,6 and those of other authors have dispelled the vague notion that physicians may somehow violate some federal law if they depart from the recommendations of package literature. Nothing in the Federal Food, Drug, and Cosmetic Act supports this erroneous belief; spokesmen for the Food and Drug Administration (FDA), the agency that enforces the Act, have repeatedly acknowledged this fact. Best medicine often requires that a physician depart from package insert recommendations. Naturally, such de¬ parture should be based on solid scientific evidence and sound judgment. Even in this circumstance, however, a disagreeable reality must be recognized: a physician who deviates from a manufacturer's recommendations in pre¬ scribing a drug may be confronted by that literature in court if something goes wrong. Of course, such literature is subject to rebuttal. Nevertheless, if all goes well at the trial, the competent and exonerated physician has still been subjected to a harrowing and grotesque experience. That fact leads to a decision that must often be made in the practice of medicine. Physicians must squarely acknowledge certain alternatives. One is to practice defensive medicine, never varying from package insert recommendations, rec¬ ognizing that sometimes this will deprive patients of opti¬ mum care, but hoping that it may diminish a degree of litigation risk. The other is to use drugs according to the carefully determined medical need for them—and if harm unfortunately is attributed to some unlabeled use, to as¬ sume or at least to hope that the case will be tried prop¬ erly—that insofar as the package insert becomes involved, it will be considered in the light of how well it reflects prescribing standards and not in the sense that it sets them. A major purpose of "A Guide into Chaos"1 was to illustrate how absurd is the notion that labeling can legiti¬ mately set standards. A great danger is this: if the medical profession ever comes to believe such a notion, the courts may come to accept the belief. To his credit, Hamit evidently rejects the belief. It is also interesting that Lasagna and Wardell8 have noted
In
a
letter
Address editorial communications to the
the FDA approved labeling recommending for angina pectoris, "some cardiologists came to consider a recommendation for coronary artery surgery without a trial of propranolol a form of malpractice." John D. Archer, MD
before propranolol that
Vexing Decision
Editor, 535 N Dearborn St, Chicago,
Senior Editor
1. Archer
1974. 2. Archer
JD: A guide into chaos: Resist it. JAMA 227:1397-1388,
JD, Kosman ME: Propranolol
controversy.
JAMA 227:201\x=req-\
202, 1974.
JD: Methylpredisolone for sunburn, FDA and package innotwithstanding. JAMA 225:72, 1973. 4. Hussey HH, Archer JD: Propranolol and labeling. Ann Intern Med 79:608, 1973. 5. Archer JD: Instrument or impediment? The regulatory monograph in medical communications. JAMA 220:1474-1477, 1972. 6. Investigational exemption procedures for new drugs, AMA Department of Drugs. JAMA 213:1902-1904, 1970. 7. Package inserts of drugs\p=m-\relatedproblems, AMA Department of Drugs. JAMA 194:187-189, 1965. 8. Lasagna L, Wardell WM: The FDA, politics, and the public. JAMA 232:141-142, 1975. 3. Archer
sert
When is
Tonsillectomy Indicated?
There is hardly any area in which we have more experience and less knowledge than the physiology and pathology of the lymphoid tissue of the throat. We still do not know enough about the functions of the tissue that constitutes the Waldeyer ring, the influence of infections of this tissue on the patient's general health, and the role of tonsillectomy and adenoidectomy in prevention of rheumatic fever. More than two years ago, the American Council on Otolaryngology formed an Ad Hoc Committee on Tonsillectomy and Adenoidectomy, in an attempt to define clear indications for these procedures. The committee consisted of 11 outstanding scientists under the chairmanship of Charles D. Bluestone, MD, professor of otolaryngology at the University of Pittsburgh School of Medicine. The committee suggested that investigations be undertaken in epidemiology, pathogenesis, and pathophysiology of tonsillitis and adenoidal hypertrophy. Under a grant of the National Institute of Neurological Diseases and Stroke, a workshop on tonsillectomy and adenoidectomy was convened June 12 through 14, 1974, at West Newton, Mass. It was again chaired by Dr. Bluestone; 27 outstanding scientists in otolaryngology and related dis¬ ciplines participated. The scientific papers read at the work¬ shop were published this spring; they cover a wide range of topics including the relation of tonsillar pathology to res¬ piratory, cardiovascular, and otological systems. The participants of the workshop, however, found that an
additional,
more
prospective study IL 60610
Downloaded From: http://jama.jamanetwork.com/ by a University of Manitoba User on 06/19/2015
extensive, nationwide collaborative
is needed of the effects of
tonsillectomy
