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Needed: better clinical testing of drugs
editorials
Needed: better clinical testin g of d ru gs
T he A m erican D ental Association supports proposed legislation which would give the public greater assurance th a t the drugs which it uses are both safe and efficacious. I t is hoped, however, th a t the efforts to improve our drug laws will include measures to correct a m ajor deficiency in present drug research: inadequate clinical testing. This deficiency has always prevailed, b u t it ordinarily does not receive serious discussion in lay circles unless a new d rug causes serious injury to humans. W hen a tragedy occurs, however, discussion is plentiful and critical. T he recent thalidom ide incident has produced an abundance of criticism, and, as usual, m uch of it is aim ed at the drug laws and at the drug m anufacturers. Little is said about the adequacy of the clinical tests themselves. I t is the m anufacturers’ responsibility to m arket only those drugs which are safe, and it is the responsibility of the F6od and D rug A dm inistration to see to it th a t the m anufacturers comply. However, the fulfillment of these responsibilities is m ade difficult by the inadequacy of personnel and facilities for clinical drug testing. D rug firms rely heavily on clinicians not in their employ to conduct proper clinical tests on new drugs. U nfortunately, however, the num ber of investigators capable of conducting truly m eaningful clinical drug testing is astonishingly low, and m any of the clinical facilities where the testing m ust be done are woefully inadequate. Financial support of clinical testing lags behind support given for laboratory research. Clinical research w hich requires additional support includes th at on dental filling materials. A lthough it is encouraging th a t funds have been earm arked for the support of clinical research centers in the dental research budget of the Public H ealth Service for 1963, other measures should be taken. These include the estab lishment of additional facilities for the clinical testing of drugs and dental materials and the initiation of program s for the training of clinical investigators. P art of this support can be given to state public health departm ents. I t is indeed unfortunate and surprising th a t the House of Representatives has not yet seen fit to pass the bill (H .R . 4742) which would provide grants for dental public health divisions in the states.
98/532 • THE JOURNAL OF THE AMERICAN DENTAL ASSOCIATION
T h e associations representing the health professions have the responsibility of guiding their members and the public in m atters relating to therapeutic agents, m ate rials and devices. T h e A m erican D ental Association does well in providing this type of guidance. T h e Council on D ental Research, for example, tests and certifies filling materials. T h e Council on D ental Therapeutics of the Association is equally im por tant. I t is the only agency in the U n ited States which conducts a drug acceptance program , and it is the only agency which formally commits itself on b o th the safety and efficacy of all drugs w hich come under its purview. O f this the dental profession can be proud. However, the Councils can assess only th a t inform ation which is available, and d ata from clinical testing often are plainly inadequate. I t is hoped th a t the Congress will fulfill its responsibility of providing the necessary regulatory laws an d financial assistance which will enable the collection of adequate clinical d ata on biological m aterials and th at, in so doing, dentistry receives fair consideration.
The use of dru g nam es in professional journals
Early this year the A nti-trust an d M onopoly Subcom m ittee of the Senate Judiciary C om m ittee concluded its 28 m onth exploration of the nation’s pharm aceutical industry. W h at the results of the investigation will be, tim e alone will tell. W hether they will provide the public an d the professions w ith better products at better prices, advertised w ith a better regard for fact and veracity, or w hether the findings will be stored away, unused, in governm ent archives— as has happened to some in the past— remains to be seen. T o date, the com m ittee’s labors have resulted in one favorable, and im portant, by-product. They have caused a growing num ber of editors to look into— and attem p t to correct— the m anner in w hich they refer to pharm aceuticals in their publications. Presently there is no uniform ity in such practices. Some publications use trad e nam es w ith no hesitation. O thers use only the generic or nonproprietary nam e of a drug. Still others prefer the use of chemical names, whereas others use all designations indiscriminately. I t has long been the policy of th e Am erican D ental Association to use only nonpro prietary d rug nam es in the title of articles appearing in its publications. Furtherm ore, it is the Association’s publication policy to use the nonproprietary nam e of a drug— when such exists— throughout the body of the text w ith the exception th at the first tim e the drug is m entioned th e tradem ark nam e may be p u t in parentheses after the nonproprietary nam e for purposes of identification. T h e first letter of a tradem ark nam e is capitalized. T h e A m erican V eterinary M edical Association employs a different policy. Its publication restricts trade names to footnotes. T h e nonproprietary nam e of a drug is used throughout th e text of an article but at first m ention of the drug an asterisk
Needed: better clinical testin g of d ru gs
T he A m erican D ental Association supports proposed legislation which would give the public greater assurance th a t the drugs which it uses are both safe and efficacious. I t is hoped, however, th a t the efforts to improve our drug laws will include measures to correct a m ajor deficiency in present drug research: inadequate clinical testing. This deficiency has always prevailed, b u t it ordinarily does not receive serious discussion in lay circles unless a new d rug causes serious injury to humans. W hen a tragedy occurs, however, discussion is plentiful and critical. T he recent thalidom ide incident has produced an abundance of criticism, and, as usual, m uch of it is aim ed at the drug laws and at the drug m anufacturers. Little is said about the adequacy of the clinical tests themselves. I t is the m anufacturers’ responsibility to m arket only those drugs which are safe, and it is the responsibility of the F6od and D rug A dm inistration to see to it th a t the m anufacturers comply. However, the fulfillment of these responsibilities is m ade difficult by the inadequacy of personnel and facilities for clinical drug testing. D rug firms rely heavily on clinicians not in their employ to conduct proper clinical tests on new drugs. U nfortunately, however, the num ber of investigators capable of conducting truly m eaningful clinical drug testing is astonishingly low, and m any of the clinical facilities where the testing m ust be done are woefully inadequate. Financial support of clinical testing lags behind support given for laboratory research. Clinical research w hich requires additional support includes th at on dental filling materials. A lthough it is encouraging th a t funds have been earm arked for the support of clinical research centers in the dental research budget of the Public H ealth Service for 1963, other measures should be taken. These include the estab lishment of additional facilities for the clinical testing of drugs and dental materials and the initiation of program s for the training of clinical investigators. P art of this support can be given to state public health departm ents. I t is indeed unfortunate and surprising th a t the House of Representatives has not yet seen fit to pass the bill (H .R . 4742) which would provide grants for dental public health divisions in the states.
98/532 • THE JOURNAL OF THE AMERICAN DENTAL ASSOCIATION
T h e associations representing the health professions have the responsibility of guiding their members and the public in m atters relating to therapeutic agents, m ate rials and devices. T h e A m erican D ental Association does well in providing this type of guidance. T h e Council on D ental Research, for example, tests and certifies filling materials. T h e Council on D ental Therapeutics of the Association is equally im por tant. I t is the only agency in the U n ited States which conducts a drug acceptance program , and it is the only agency which formally commits itself on b o th the safety and efficacy of all drugs w hich come under its purview. O f this the dental profession can be proud. However, the Councils can assess only th a t inform ation which is available, and d ata from clinical testing often are plainly inadequate. I t is hoped th a t the Congress will fulfill its responsibility of providing the necessary regulatory laws an d financial assistance which will enable the collection of adequate clinical d ata on biological m aterials and th at, in so doing, dentistry receives fair consideration.
The use of dru g nam es in professional journals
Early this year the A nti-trust an d M onopoly Subcom m ittee of the Senate Judiciary C om m ittee concluded its 28 m onth exploration of the nation’s pharm aceutical industry. W h at the results of the investigation will be, tim e alone will tell. W hether they will provide the public an d the professions w ith better products at better prices, advertised w ith a better regard for fact and veracity, or w hether the findings will be stored away, unused, in governm ent archives— as has happened to some in the past— remains to be seen. T o date, the com m ittee’s labors have resulted in one favorable, and im portant, by-product. They have caused a growing num ber of editors to look into— and attem p t to correct— the m anner in w hich they refer to pharm aceuticals in their publications. Presently there is no uniform ity in such practices. Some publications use trad e nam es w ith no hesitation. O thers use only the generic or nonproprietary nam e of a drug. Still others prefer the use of chemical names, whereas others use all designations indiscriminately. I t has long been the policy of th e Am erican D ental Association to use only nonpro prietary d rug nam es in the title of articles appearing in its publications. Furtherm ore, it is the Association’s publication policy to use the nonproprietary nam e of a drug— when such exists— throughout the body of the text w ith the exception th at the first tim e the drug is m entioned th e tradem ark nam e may be p u t in parentheses after the nonproprietary nam e for purposes of identification. T h e first letter of a tradem ark nam e is capitalized. T h e A m erican V eterinary M edical Association employs a different policy. Its publication restricts trade names to footnotes. T h e nonproprietary nam e of a drug is used throughout th e text of an article but at first m ention of the drug an asterisk