counsellors. Investment decisions made by these counsellors are solely for the benefit of the fund's beneficiaries using prudent management practices without AMA input or control into the selection of a portfolio. 2. Question. What proportion of the costs of production of the Journal of the American Medical Association are derived from pharmaceutical company advertising? Answer. In the publishing industry the "costs of production" for a magazine usually include only the cost of paper and printing. We interpret your question to mean the proportion of the cost of "putting out" JAMA that is offset by pharmaceutical advertising. These costs reflect all the costs of production and distribution of the magazine including editorial salaries, the costs of selling advertising, the publication and printing of editorial and advertising pages, and postage. 56.5 percent of the cost of "putting out" JAMA are offset by pharmaceutical company ad sales as indicated below. Total advertising sales (1977). Deduct: Classified ad sales___ Estimated nonpharmaceutical company ad sales--- Total estimated pharmaceutical company ad sales. Total AMA Cost of JAMA (1977). Ratio of sales ($4,762,000) to cost ($8,432,000) (percent). $5, 956, 000 $994, 000 $200,000 $1, 194, 000 $4,762, 000 $8, 432, 000 56.5 3. Question. Is there an AMA policy to investigate whether authors of clinical or research articles accepted for publication in the Journal are recipients of grants from pharmaceutical manufacturers? If so, please detail what this policy is and let us have examples of any questionnaire or other investigative materials that may have been employed. Also, please state whether it is the policy of the Journal to make this fact known to its readers. Answer. There is no specific policy for AMA Journal editors to determine the source of support for research that is the basis of an acceptable manuscript submitted to the Journal. As a matter of fact though, most if not all, manuscripts that report work done under a grant from the government, a voluntary health agency, philanthropic foundations, or private business indicate such support on the title page. Such information is always reported in JAMA as a footnote to the first page of the article. Many authors report multiple sources of support for a single piece of work. When this is the case, all the reported sources are indicated in the journal. 4. Question. Does the AMA Code of Ethics include any reference to members that local societies, researchers, and practitioners should avoid the appearance of conflict of interest by the ownership of equity in pharmaceutical manufacturing companies, wholesale drug companies or retail pharmacies? Answer. The AMA Judicial Council has found that it is not improper for a physician to have an ownership interest in a pharmaceutical company or pharmacy (as is the right of any citizen), provided that there is no exploitation of the patient by such devices as fee splitting, over-utilization, patient steering, etc. The ethical issue concerns abuse of the patient-physician relationship, not the ownership of equity interests. Enclosed is a full copy of the Judicial Council's opinion on this subject. 5. Question. Are AMA conventions subsidized in any respect by pharmaceutical manufacturers? Please give details. Answer. AMA conventions are not subsidized by pharmaceutical manufacturers in the sense that revenues from pharmacy industry exhibits and advertisements in the convention program provide operating funds for either the convention or AMA general revenues. These exhibits do not generate a "profit" for AMA and basically revenues from industrial exhibits usually just cover the cost of providing the exhibit space and services for the industrial and scientific exhibitions. Exhibits must be pre-approved by the AMA. Acceptability of claims contained in exhibits is determined using the same criteria as that used in advertising in AMA publications. A list of relevant regulations pertaining to scientific and pharmaceutical company exhibits are attached. 6. Question. Please state why the AMA Council on Drugs was disbanded in 1971 and what mechanisms, if any, remain at AMA to take its place. Answer. In 1972, the AMA Board of Trustees dissolved four of its standing councils and several of its standing committees. Among these was the Council on Drugs. In the two years thereafter, most of the remaining councils and committees of AMA were dissolved. These actions were taken for two reasons: (1) to improve organizational methods for implementing AMA programs; and (2) to a lesser extent, the containment of costs. For almost 50 years, the AMA Council on Drugs had principal responsibility for issuing a series of volumes designed to provide physicians with authoritative, current information on prescription drugs. Among these volumes were New and Non-official Remedies (NNR) New and Non-official Drugs (NND), New Drugs (ND), and most recently, AMA Drug Evaluations (AMA-DE). In the years immediately preceding its dissolution, the Council on Drugs was devoted exclusively to the review and approval of AMA-DE and was responsible for the content of the first two editions published in 1971 and 1973. The actual content of the volume was and is prepared by staff physicians and pharmacologists at AMA. The individual chapters are written after a thorough review of the scientific literature on the subject matter, plus consultation with a large group of distinguished physicians and clinical pharmacologists who provide their opinion on accuracy as a gratis service to medicine. The role of the Council on Drugs was that of a clearance body for staff prepared chapters. The Council was composed of 12 respected physicians. However, it was felt that a broader range of expertise was desirable to deal with the expanding number of drugs contained in AMA-DE. The AMA Board of Trustees was cognizant of this problem when it decided to dissolve the Council on Drugs in 1972. In order to assure the continued high level of competency in the review of AMA-DE, the Board directed that the continued publication of AMA-DE carry the sponsorship of another widely respected group of drug experts. This joint sponsorship was arranged between AMA and the American Society of Clinical Pharmacology and Therapeutics (ASCPT). ASCPT is often referred to as the "premier" society of drug experts in the United States. In operation, the ASCPT, drawing upon its own membership of almost 1,000 pharmacologists and clinicians, can provide a broader range of expertise than was available with the Council on Drugs. In summary, replacement of the former Council on Drugs by the members of the American Society of Clinical Pharmacology and Therapeutics has resulted in a more efficient operation and has produced a more authoritative publication. 7. Question. Please state and identify any articles that have been rejected for inclusion in the Journal because of promotion or unacceptable ethical practices. The same question as to advertising rejections by the Journal. Answer. The current Editor-in-Chief of the Journal has indicated that in the approximately 31⁄2 years of his tenure as Editor-in-Chief, he has not received any articles promoting an unacceptable ethical practice. With respect to advertising rejections, AMA, like all other medical publishers, presume clearance of statements made in pharmaceutical advertising by FDA as required by the current Food, Drug and Cosmetic Act. As a result, there are very few instances of "unethical" advertisements being submitted to AMA and consequently few rejections. Since 1975, there have been only two pharmaceutical ads rejected for reason of ethics. Both involved questionable price comparisons. After both ads were rejected, the sponsoring company subsequently modified the ads and they were run, as revised, in the Journal. 8. Question. Does AMA conduct any research regarding the side effects of psychotropic substances? If so, please explain the program and what it encompasses. Answer. The AMA no longer directly conducts scientific research. In order to better use the limited resources available to the Association, AMA has instead a major disseminator of current scientific information through the Journal of American Medical Association and the various archives and specialty journals that it publishes. 9. Question. Please state your views regarding the criticism leveled against the use of major tranquilizers by recent articles in the New Republic Magazine by Elliot Marshall. The article quotes Dr. Peter Breggin as saying, "There is no restraint shown by the physician in the use of these psychotropic drugs". A spokesman for the American Psychiatric Association, Dr. Frazier, from Boston, conceded that "some doctors prescribe these drugs too freely and too frequently." Comments would be appreciated. Answer. The article appearing in the August 26-September 2, 1978 edition of the New Republic speaks to the subject of the use of anti-psychotic drugs. The article reports the comments of a Washington, D.C. psychiatrist that major tranquilizers, those drugs used to treat severe mental disturbances (the so-called anti-psychotic drugs) are being over-utilized and forced upon patients in both the institutional and community settings. The article implies that these drugs are being used as a method of containment and control of mentally disturbed persons and that the root-causes of the patient's problems are not adequately addressed. It is also stated that the drugs are ineffective and may cause irrevocable neurological damage and that physicians are exercising no prudence in the use of these drugs. Without speaking directly to the article, AMA's policy concerning the use of anti-psychotic drugs is contained in AMA-DE. That policy states that although anti-psychotic drugs are not curative, they are effective in the management of schizophrenic psychosis. Anti-psychotic agents decrease agitation, hostility, combativeness, and hyperactivity as well as ameliorate delusions, hallucinations, disordered thought and perception, emotional and social withdrawal, paranoid symptoms, and personal neglect. These drugs allow many individuals to leave the institutional setting, accept gainful employment and maintain their productivity. The AMA believes that the selection and use of any therapeutic regimen should take place as part of the patient-physician relationship. The patient should, where possible, participate in the treatment decision. However, in cases where the patient is incompetent or unable to agree to or consent to a specific procedure, a responsible relative or judicial body should be authorized to make such determinations for the benefit of the patient. Furthermore, when a patient poses an imminent threat of harm to himself or others, emergency medical intervention, including drug therapy, should not be held in abeyance pending the location of a relative or the completion of the judicial process. The drugs discussed in the cited article pose significant risks and likewise impart significant benefits. These risks and benefits must be weighed by the prescribing physician each time a treatment decision is made. We believe that it is unfair and irresponsible to allege that "there is no restraint shown by the physician in the use of these psychotropic drugs." Such an allegation, in effect, is saying that there are no physicians who exercise prudence or good medical judgment in the use of these drugs. Such an allegation is patently untrue. 10. Question. Finally, what do you see as the role of the physician and the role of AMA in making a real effort to contain the flood of legal substances available to users? Should an upper limit be established as a matter of ethical prescribing practices? Answer. The AMA believes that psychotropic drugs have been of great benefit in the treatment of patients for a variety of disorders and symptomatic relief. The role of physician in preventing the diversion of legally obtained drugs for non-medical uses is stated in AMA-DE as follows: Because of the proliferation of psychotropic substances the physician, today more than ever before, should guard against contributing to drug abuse through injudicious prescription practices or by acquiescence to the demands of some patients for instant chemical answers to their problems . . . in essence he can play a preventive role in his practice exercising good judgment in administering and prescribing psychotropic drugs, so that diversion to illicit use is avoided and the development of drug dependence is minimized or prevented. In this context any non-medical use of the drug would be considered an illicit use of the drug. To aid the physician in reaching proper treatment decisions, AMA and the major medical professional and specialty societies have in the past, and will continue in the future, to develop and publish recommended prescribing guidelines for various drugs. However, the establishment of an upper limit of the amount of a drug to be prescribed to a patient fails to recognize the individual needs of a particular patient. Ethically, a physician should only prescribe drugs in the quantity necessary to meet the medical objectives of the patient's case. The prescribing of a drug either above or below the medical need is poor practice and thereby inappropriate. OPINIONS AND REPORTS AMERICAN MEDICAL ASSOCIATION 6.16. DRUGS AND DEVICES: PRESCRIBING It is unethical for a physician to be influenced in the prescribing of drugs or devices by his direct or indirect financial interest in a pharmaceutical firm or other supplier. It is immaterial whether the firm manufactures or repackages the products involved. It is unethical for a physician to own stock or have a direct or indirect financial interest in a firm that uses its relationship with physician-stockholders as a means of inducing or influencing them to prescribe the firm's products. Practicing physicians should divest themselves of any financial interest in firms that use this form of sales promotion. Reputable firms rely on quality and efficacy to sell their products under competitive circumstances, not on appeal to physicians with financial involvements which might influence them in their prescribing. On the other hand, it cannot be considered unethical for a physician to own or operate a pharmacy provided there is no exploitation of his patient. The physician is permitted to exercise his own best judgment when caring for his patients. It is known that there will be situations when it is necessary or desirable for a physician to dispense or supply what he has prescribed. The principles permit this to be done. A physician in the exercise of sound discretion may dispense "in the best interest of his patient"; he may not dispense solely for his convenience or for the purpose of supplementing his income, especially if the drug needs of the patients can be adequately met by local pharmacies. Physicians who enter into agreements with pharmacists in the dispensing of prescriptions in code are guilty of unethical practices and should be disciplined by their local society. It is also unethical for physicians to use prescription blanks with the name of a pharmacy printed thereon. A patient is entitled to a copy of his or her prescription for glasses, drugs, or appliances and he has the privilege of having the prescription filled wherever he wishes. The principle of free choice applies as well to the choice of a pharmacy. Accordingly, the Council looks with disfavor upon the use of direct telephone lines between a physician and a pharmacist on the theory that a patient is entitled to a written prescription which he can take to the pharmacist of his choice. EXHIBIT INFORMATION AND REGULATIONS GENERAL The primary purpose of Conventions of this Association is the continuing medical education of physicians. It must be borne in mind by all exhibitors that their participation in these important meetings must support the central purpose of the Convention, and must be regarded as an educational and awareness opportunity, rather than a mercantile venture. The following outline of Information and Regulations will help you make the proper business decisions as to whether or not to participate. Exhibit Eligibility: The eligibility of each product or service for exhibition at the Convention shall be determined by the AMA Office of Advertising Evaluation, and by the AMA Office of Industrial Exhibits. Only those products and claims ruled to be acceptable may appear in an exhibit. These judgments are governed by the same general principles which govern the acceptance of advertising in the AMA Scientific Publications. The following criteria shall apply: (a) Exhibition of products and services shall be restricted to those which are germane to the practice of medicine, medical education, and health care delivery. (b) Neither selling nor ordertaking are permitted at the convention site; noncompliance may result in removal of the offending exhibitor from the exhibition, and may preclude participation in future meetings. (c) Professional conduct of exhibitor personnel, as observed from previous convention activity. Approval Procedure: Along with your application and deposit, please submit photographs or sketches of the proposed booth along with the copy to be used on the visual elements of your display before your exhibit is completed in order to eliminate last minute changes should copy revision be required. All exhibits must have final approval from the Office of Advertising before September 15, 1978. Please submit all necessary materials early, since it may be necessary to supply additional data to substantiate a claim, or to support the eligibility. of a product or service for exhibit. Without prior approval from the Association, no changes may be made in an exhibit after final approval has been granted. Products proposed for exhibit will not be considered unless the submission is accompanied by copy claims and artwork as outlined above. The Association reserves the right to restrict an exhibit which may be considered undesirable. This restriction includes conduct, articles, printed matter, samples, questionnaires, movies, interviews of physicians, attire of personnel, or any other action that might be objectionable. Sampling of Ineligible Products is Prohibited: If there is any question concerning eligibility of items for exhibit, please communicate with the Office of Advertising Evaluation at least eight weeks prior to the Convention. The generic name of any pharmaceutical product exhibited must also be stated below its trade name in booth backwall and display panels. The American Medical Association will not permit Industrial Exhibitors to include in their exhibits at the Convention any new product for which there is no effective New Drug Application, or products which are not commercially available for use by physicians in general. Any demonstration by live models must be approved in advance by the AMA Office of Industrial Exhibits. Sampling of Drugs, etc.: Sampling of legend drugs must be restricted to physicians only. Whenever possible, mail samples to the registering doctor instead of distributing them in the convention hall. No bags or containers for collection of samples are to be distributed by any exhibitor. This applies to any envelope, folder, portfolio, box, etc., that provides carrying space for more than a single sample. Clinical Testing at AMA Conventions: Because of the less than desirable conditions for clinical testing which exist in convention facilities and the possibility of legal complications, testing performed on tissues, secretions, or excretions obtanied from physicians or their families is not considered acceptable in commercial exhibits at AMA conventions. Give-Aways: The AMA Industrial Exhibit Office must have information concerning your plans in this connection at least eight weeks prior to the Convention. Give-aways must have a direct relation to your product. Any more elaborate items which tend to increase traffic at your booth primarily for acquisition purposes are prohibited. Adequate space should be provided for people to wait within the booth rather than in the aisles. Give-aways must be the end product of the exhibiting firm's manufacture and must be related to the practice of medicine. No drawings, raffles, quiz-type contests, "free" or "special" convention offers, or "schoolroom" examinations of any type will be permitted. Activities should be restricted to registration of physicians. Distribution of promotional literature and/or samples outside the confines of the exhibitors' booth is expressly prohibited. AMERICAN MEDICAL ASSOCIATION, Rep. LESTER WOLFF, Chairman, Select Committee on Narcotics Abuse and Control, DEAR CHAIRMAN WOLFF: Recently, Joseph F. Boyle, M.D., and Daniel X Freedman, M.D., presented testimony before your committee concerning the use of psychotropic drugs in medical practice on behalf of the American Medical Association. At the hearing, various members of the Committee requested AMA to submit further information. This information is enclosed for inclusion in the official records of the hearing. Sincerely, JAMES H. SAMMONS, M.D., |