the Dalkon Shield. The recitation of I contribute to this end. cases temporally associated with the F. A. Clark,Jr., MD R. W. Tankersley, PhD Dalkon Shield, stripped of all qual¬ A. H. Robins Co. ifying description as to the nature of Richmond, Va and stimuli for these reports, distorts 1. Abortion-related mortality, 1972 and 1973\x=req-\United States. Morbidity Mortality Weekly Rep 24:22-28, 1975. the discussion. There is only a hint 2. Jones RW: Septic abortion and IUD. NZ Med J that septic abortion occurs in non80:186, 1974. IUD wearers and in patients wearing an IUD with a monofilament tail. The large number of Dalkon Shields in¬ OTC Drug Review and serted during the period 1971 through Toxic Anachronisms 1973 does not appear to have had a on deleterious impact spontaneous To the Editor.\p=m-\TheFood and Drug abortion-related maternal mortality Administration (FDA) is in the midst of a major scientific review, by 17 in the United States, since such re¬ ports declined ' from 19 for 1972 to extramural advisory panels, of all of seven for 1973. A 1973 survey by the the ingredients in over-the-counter Center for Disease Control cannot be (OTC) drugs. One such hard-working interpreted as showing a difference panel, which included myself, rebetween IUDs regarding either preg¬ cently submitted its report on laxanancy-related or non-pregnancy-re¬ tives, antidiarrheals, antiemetics, and lated hospitalizations (data presented emetics, as published in the Federal before FDA Ad Hoc Advisory Com¬ Register.1 Industry and other intermittee on Obstetrics and Gynecology, ested persons have 60 days in which Aug 21-22, 1974). No firm data exist to reply to the initial reports, followto show that septic spontaneous abor¬ ing which the FDA may utilize the tion is more likely to occur with the panel's advice to issue a final monoDalkon Shield than with other IUDs.2 graph defining the safe and effective Perhaps, few will question the ingredients of a class of products. The methodology of the bacteriological monograph on antacids is already in studies reported. However, the exte¬ effect, and the antimicrobial panel is riors of the tails from the various currently undergoing final review by the FDA. IUDs removed from patients were Physicians should be aware not carefully sterilized in the experiment. While the report describes normal only of the scope of this endeavor but vaginal flora in the interior of the of the opportunity to eliminate unmultifilament tail of the Dalkon safe and often anachronistic comShield, it omits discussion of whether pounds still sold OTC. The Laxative this represents a meaningful addition Panel, for example, classified as unsafe and requiring withdrawal from to the gross number of bacteria that routinely accumulate on the exterior the market scopolamine, calomel, poof any transcervical string in situ and dophyllum resin (podophyllin), and that can serve as a potential route for other laxative resins. The other atro¬ ascending infections. pine compounds were put in category The Food and Drug Administration III (requiring more study) along with (FDA), the FDA Advisory Com¬ recommendations for dilution to re¬ mittee, and the Medical Letter duce their toxicity for children. Each of the review panels is (March 14, 1975) have recommended that an IUD of any type be removed charged only with the review of such in the event of pregnancy. ingredients as submitted by industry. The A. H. Robins Co. has acknowl¬ Although the absence of a submission edged previously the controversy that and its review is intended to have the same result as a classification of exists and will continue to exist over the multifilament tail of the Dalkon unsafe and ineffective—withdrawal Shield, and has informed the FDA from the market-a forthright classi¬ that it will change to a monofilament fication as unsafe is likely to clear the design in order to conclude this con¬ OTC shelves more rapidly than simple fusing period. It sincerely hopes that omission. Poison control personnel, for example, would be most happy to a greater understanding among phy¬ sicians and patients has developed reduce the accessibility to camphor¬ ated oil and camphor liniment and to over the past months as to the bene¬ fits and risks of IUDs and that, retire as soon as possible such oldthereby, even better preventive and timers as chloroform liniment, spirits therapeutic care for all IUD wearers of ethyl nitrite, and 2% to 7% tinc¬ will result. However, it is difficult to tures of iodine. visualize how the subject article will Recommendations from health pro-
Downloaded From: http://jama.jamanetwork.com/ by a Michigan State University User on 06/16/2015
fessionals concerning the inclusion or exclusion of OTC ingredients are given the full attention of the appro¬ priate panels. Such comments may be addressed to Robert Pinco, Director of OTC Staff, FDA, 9000 Rockville Pike, Rockville, MD 20852. Carol R. Angle, MD President. American Association of Poison Control Centers University of Nebraska College of Medicine
Omaha 1. Over-the-counter drugs: Proposed establishment of monographs for OTC laxative, antidiarrheal, emetic and antiemetic products, Food and Drug Administration. Fed Register 40:12902-12944, 1975.
of Standards To the Editor.\p=m-\Intheir COMMENTARY (231:709, 1975), Fifer and Aldrich deplored the fact that labeling information supplied by manufacturers often lags far behind known benefits and actual usage of a given medication. But I think that they failed to emphasize sufficiently that the wording of package inserts, advertising, and other information regarding the use of this drug is rigidly controlled by officials of the Food and Drug Administration (FDA). The manufacturers of Xylocaine (lidocaine) probably were quite aware of its value in controlling cardiac arrhythmias, and the manufacturers of Valium (diazepam) probably had ample evidence that it is
Tyranny
the drug of choice for status epilepticus long before FDA officials allowed them to say so in their package inserts and promotional information. Warnings against the use of Valium for convulsive disorders most likely were included in the package inserts at the insistence of FDA officials and under at least implied threats of confiscation and other dire consequences; getting approval to update this infor¬ mation probably cost the manufac¬ turer thousands of dollars to support clinical research to substantiate for the FDA what clinicians already knew and dozens of appearances by the manufacturer's representatives to plead, hat in hand, for these revisions before autocratic FDA "scientists," many of whom have not practiced clinical medicine for years, if ever. Fortunately, the FDÀ bureaucrats have had little direct control over the uses to which clinicians actually put a marketed drug, but the clinician who ignores warnings or deviates from proscribed indications and contraindi¬ cations for a drug does so at some le¬ gal hazards; some have been willing to accept those hazards for possible
benefits to their patients. On the basis of past experience, it seems al¬ most self-evident that the practice of medicine under the regulatory fiat of government bureaucrats quite likely will lead only to deterioration rather than improvement in the quality of medical care received by the patient. Harold F. Hamit, MD Charlotte, NC
The Immorality of New York's Doctors' Strike To the Editor.\p=m-\Therecent doctors' strike in New York City reemphasizes serious questions surrounding the morality and ethics of a physician "abandoning" his patients. Is there ever an issue greater in importance to a physician than the care of his patients? Can financial considerations or working conditions ever be of such a nature that they override the doctor's primary responsibility of caring for his patients? I think not. The League of Voluntary Hospitals and the Committee of Interns and Residents (CIR) were unable to resolve their differences, so that a strike ensued. Most issues had been satisfactorily resolved prior to the strike. The major stumbling block was the demand by the CIR that the workweek for house staff not exceed 80 hours. The League had proposed that house staff not work more than every third night, a schedule that would average out to approximately 80 hours a week. Yet the two sides were unable to find a mutually agreeable formula concerning the length of the workweek. A major principle that neither side wished to compromise was at stake. The basic issues that led to the strike, however, do not and cannot separate the doctor from his (or her) patient. For a physician to strike, for whatever reason, is unconscionable and totally contrary to every stan¬ dard of medical ethics and morality. Precedents for such actions in Can¬ ada, Israel, and the United Kingdom do not make a strike in New York any more ethical, moral, or tolerable than strikes were in those countries. How inappropriate for politicians to make remarks to the press about the bad faith of one side or the oth¬ er, without understanding the basic
principle being negotiated!
How wrong for leaders of the American Medical Association in Chicago to speak out in favor of one side without
having
firsthand
knowledge
of the
state of affairs! Such actions
only in¬ flame tempers and enrage the oppos¬ ing sides. An old Talmudic proverb asserts: do not judge your fellow man unless you yourself have been in his predicament.
Now that the strike is over, one can pause to reflect. Many house officers
have stated that they really didn't want to strike but had to in support of their militant leadership whose ac¬ tions they did not agree with, but who were the duly elected representatives of the CIR. Such statements and as¬ sertions may assuage the guilty con¬ sciences of these house officers but do not excuse their improbity for having participated in the strike. The pur¬ ported indecency of working condi¬ tions for interns and residents should not and cannot be grounds for leav¬ ing seriously ill patients in inade¬ quately attended intensive care units and hospital wards. The physician's primary responsibility is not to the CIR but to his patients. Let no one misunderstand my posi¬ tion. I sympathize with the interns and residents. I, too, agree that a 100hour workweek makes for a harried, hectic, and harrowing experience. I, too, agree that working more than 50 consecutive hours without proper rest is an intolerable burden on house offi¬ cers. I, too, agree that as great as the burden is on the young doctor, it is much greater on the patient. I, too, would not like to be treated or oper¬ ated on by a physician who has not slept for 36 hours. However, the im¬ morality of a doctor leaving his pa¬ tients while he is out on the picket line strikes at the very fabric of medi¬ cal ethics. It might be morally accept¬ able if the doctor refuses to accept new patients and even if he refuses to perform all tasks and chores not
directly concerned with patient care. However, to leave his patients with¬
out his direct medical assistance and
attendance puts the striking house officer in an untenable moral position. There was no legal proscription against the strike, but what is legal is not always right. Legal permissibility is not synonymous with moral license. Fred Rosner, MD Queens Hospital Center
Queens, NY
Prescriptions for the Traveler To the Editor.\p=m-\Inour world of
transport, patients
can
rapid
find them-
selves in a foreign country where the loss of their baggage can mean the
Downloaded From: http://jama.jamanetwork.com/ by a Michigan State University User on 06/16/2015
loss of their drug supply. Obtaining the correct drug may be made more complex by not only the biological availability variation of the foreign product but by its trade name, made evident by the following two exam-
ples. First, the
trade name Cardoxin is used in Israel for dipyridamole, the coronary dilater; the same name is used in Australia for digoxin.1 Second, the trade name Didion, used in Europe to indicate the antiepileptic, ethadione,2 is used in Israel for the indandione anticoagulant, di-
phenadione.
These two examples only emphasize the care that must be taken in writing that "safety" prescription for the traveler. The generic or chemical name must always be included with the trade name to prevent this type of inadvertent and potentially dangerous
error. Norman H. Eisenberg Ruth Kitzes-Cohen, MD Silvio Pitlik, MD Beilinson Medical Center Petah Tikva, Israel
1. Martindale W: The Extra
Pharmacopoeia, ed 26. London, Pharmaceutical Press, 1967. 2. Index Nomium. Swiss Pharmaceutical Society, 1973\x=req-\ 1974.
Table
the ORIGINAL Errors.In CONTRIBUTION, "External Counterpulsation: Management of Cardiogenic Shock After Myocardial Infarction," published in the Sept 9 issue (229:1441-1450, 1974), errors occurred in Tables 2 and 4. In Table 2 (p 1443), the V, urine output of patient 11 was 0 and he was given a diuretic (\s=s\should follow 0). In Table 4 (p 1446), the condition of patient 4 after ECP was that he "Could not maintain blood pressure without assist." As published, the word "without" was omitted.
Dosage
Error. In
the
LETTER TO
"Administration of Aspirin Tablets," published in the June
THE EDITOR,
(232:1007, 1975), a dosage incorrectly converted. The last sentence of point 3 (third column, first paragraph) originally stated that it would require 3 fl oz of orange juice to dissolve one 5-grain tablet. This is the equivalent of a 300-mg tablet, not a 3-mg tablet, as printed. 9 issue was
Downloaded From: http://jama.jamanetwork.com/ by a Michigan State University User on 06/16/2015
fessionals concerning the inclusion or exclusion of OTC ingredients are given the full attention of the appro¬ priate panels. Such comments may be addressed to Robert Pinco, Director of OTC Staff, FDA, 9000 Rockville Pike, Rockville, MD 20852. Carol R. Angle, MD President. American Association of Poison Control Centers University of Nebraska College of Medicine
Omaha 1. Over-the-counter drugs: Proposed establishment of monographs for OTC laxative, antidiarrheal, emetic and antiemetic products, Food and Drug Administration. Fed Register 40:12902-12944, 1975.
of Standards To the Editor.\p=m-\Intheir COMMENTARY (231:709, 1975), Fifer and Aldrich deplored the fact that labeling information supplied by manufacturers often lags far behind known benefits and actual usage of a given medication. But I think that they failed to emphasize sufficiently that the wording of package inserts, advertising, and other information regarding the use of this drug is rigidly controlled by officials of the Food and Drug Administration (FDA). The manufacturers of Xylocaine (lidocaine) probably were quite aware of its value in controlling cardiac arrhythmias, and the manufacturers of Valium (diazepam) probably had ample evidence that it is
Tyranny
the drug of choice for status epilepticus long before FDA officials allowed them to say so in their package inserts and promotional information. Warnings against the use of Valium for convulsive disorders most likely were included in the package inserts at the insistence of FDA officials and under at least implied threats of confiscation and other dire consequences; getting approval to update this infor¬ mation probably cost the manufac¬ turer thousands of dollars to support clinical research to substantiate for the FDA what clinicians already knew and dozens of appearances by the manufacturer's representatives to plead, hat in hand, for these revisions before autocratic FDA "scientists," many of whom have not practiced clinical medicine for years, if ever. Fortunately, the FDÀ bureaucrats have had little direct control over the uses to which clinicians actually put a marketed drug, but the clinician who ignores warnings or deviates from proscribed indications and contraindi¬ cations for a drug does so at some le¬ gal hazards; some have been willing to accept those hazards for possible
benefits to their patients. On the basis of past experience, it seems al¬ most self-evident that the practice of medicine under the regulatory fiat of government bureaucrats quite likely will lead only to deterioration rather than improvement in the quality of medical care received by the patient. Harold F. Hamit, MD Charlotte, NC
The Immorality of New York's Doctors' Strike To the Editor.\p=m-\Therecent doctors' strike in New York City reemphasizes serious questions surrounding the morality and ethics of a physician "abandoning" his patients. Is there ever an issue greater in importance to a physician than the care of his patients? Can financial considerations or working conditions ever be of such a nature that they override the doctor's primary responsibility of caring for his patients? I think not. The League of Voluntary Hospitals and the Committee of Interns and Residents (CIR) were unable to resolve their differences, so that a strike ensued. Most issues had been satisfactorily resolved prior to the strike. The major stumbling block was the demand by the CIR that the workweek for house staff not exceed 80 hours. The League had proposed that house staff not work more than every third night, a schedule that would average out to approximately 80 hours a week. Yet the two sides were unable to find a mutually agreeable formula concerning the length of the workweek. A major principle that neither side wished to compromise was at stake. The basic issues that led to the strike, however, do not and cannot separate the doctor from his (or her) patient. For a physician to strike, for whatever reason, is unconscionable and totally contrary to every stan¬ dard of medical ethics and morality. Precedents for such actions in Can¬ ada, Israel, and the United Kingdom do not make a strike in New York any more ethical, moral, or tolerable than strikes were in those countries. How inappropriate for politicians to make remarks to the press about the bad faith of one side or the oth¬ er, without understanding the basic
principle being negotiated!
How wrong for leaders of the American Medical Association in Chicago to speak out in favor of one side without
having
firsthand
knowledge
of the
state of affairs! Such actions
only in¬ flame tempers and enrage the oppos¬ ing sides. An old Talmudic proverb asserts: do not judge your fellow man unless you yourself have been in his predicament.
Now that the strike is over, one can pause to reflect. Many house officers
have stated that they really didn't want to strike but had to in support of their militant leadership whose ac¬ tions they did not agree with, but who were the duly elected representatives of the CIR. Such statements and as¬ sertions may assuage the guilty con¬ sciences of these house officers but do not excuse their improbity for having participated in the strike. The pur¬ ported indecency of working condi¬ tions for interns and residents should not and cannot be grounds for leav¬ ing seriously ill patients in inade¬ quately attended intensive care units and hospital wards. The physician's primary responsibility is not to the CIR but to his patients. Let no one misunderstand my posi¬ tion. I sympathize with the interns and residents. I, too, agree that a 100hour workweek makes for a harried, hectic, and harrowing experience. I, too, agree that working more than 50 consecutive hours without proper rest is an intolerable burden on house offi¬ cers. I, too, agree that as great as the burden is on the young doctor, it is much greater on the patient. I, too, would not like to be treated or oper¬ ated on by a physician who has not slept for 36 hours. However, the im¬ morality of a doctor leaving his pa¬ tients while he is out on the picket line strikes at the very fabric of medi¬ cal ethics. It might be morally accept¬ able if the doctor refuses to accept new patients and even if he refuses to perform all tasks and chores not
directly concerned with patient care. However, to leave his patients with¬
out his direct medical assistance and
attendance puts the striking house officer in an untenable moral position. There was no legal proscription against the strike, but what is legal is not always right. Legal permissibility is not synonymous with moral license. Fred Rosner, MD Queens Hospital Center
Queens, NY
Prescriptions for the Traveler To the Editor.\p=m-\Inour world of
transport, patients
can
rapid
find them-
selves in a foreign country where the loss of their baggage can mean the
Downloaded From: http://jama.jamanetwork.com/ by a Michigan State University User on 06/16/2015
loss of their drug supply. Obtaining the correct drug may be made more complex by not only the biological availability variation of the foreign product but by its trade name, made evident by the following two exam-
ples. First, the
trade name Cardoxin is used in Israel for dipyridamole, the coronary dilater; the same name is used in Australia for digoxin.1 Second, the trade name Didion, used in Europe to indicate the antiepileptic, ethadione,2 is used in Israel for the indandione anticoagulant, di-
phenadione.
These two examples only emphasize the care that must be taken in writing that "safety" prescription for the traveler. The generic or chemical name must always be included with the trade name to prevent this type of inadvertent and potentially dangerous
error. Norman H. Eisenberg Ruth Kitzes-Cohen, MD Silvio Pitlik, MD Beilinson Medical Center Petah Tikva, Israel
1. Martindale W: The Extra
Pharmacopoeia, ed 26. London, Pharmaceutical Press, 1967. 2. Index Nomium. Swiss Pharmaceutical Society, 1973\x=req-\ 1974.
Table
the ORIGINAL Errors.In CONTRIBUTION, "External Counterpulsation: Management of Cardiogenic Shock After Myocardial Infarction," published in the Sept 9 issue (229:1441-1450, 1974), errors occurred in Tables 2 and 4. In Table 2 (p 1443), the V, urine output of patient 11 was 0 and he was given a diuretic (\s=s\should follow 0). In Table 4 (p 1446), the condition of patient 4 after ECP was that he "Could not maintain blood pressure without assist." As published, the word "without" was omitted.
Dosage
Error. In
the
LETTER TO
"Administration of Aspirin Tablets," published in the June
THE EDITOR,
(232:1007, 1975), a dosage incorrectly converted. The last sentence of point 3 (third column, first paragraph) originally stated that it would require 3 fl oz of orange juice to dissolve one 5-grain tablet. This is the equivalent of a 300-mg tablet, not a 3-mg tablet, as printed. 9 issue was
