Recent surveys of physicians indicate that even though many still oppose the practice of DTCA in general, they also point to some positive effects. A survey of family physicians in found that 80 percent of physicians believed DTCA was not a good idea Lipsky and Taylor More recently, however, in a survey of physicians conducted by the FDA, only 18 percent believed that DTC created problems with their interaction with a patient, and 41 percent said that DTC had beneficial effects on the interaction Swasy These findings contrast with the nearly universal opposition to DTCA expressed in surveys of physicians in the s.
Some consumer groups reacted negatively to the draft guidance for broadcast advertising Sasich and Wolfe The group called for a moratorium on DTCA until the FDA could issue regulations specifically governing consumer-directed advertisements. In an editorial, HRG's director acknowledged consumers' desire for more information but differentiated between drug information provided for educational purposes and advertising:.
During the past two decades, there has been an irreversible change in the nature of the doctor-patient relationship. Patients are seeking much more medical information and are actively participating in decisions affecting their health.
Intruding into this trend has been the rise of direct-to-consumer promotion, which in its initial thrust, bypasses primary care doctors and other physicians.
Although increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses is Narcotic Thrust - Safe From Harm (CD) important advance, confusion arises when commercially driven promotional information is represented as educational. Other consumer groups, however, expressed more positive views about DTCA. In98 percent of Americans reported that they had seen or heard an ad for prescription drugs.
Of those who had seen an ad, 33 percent talked to their physician about the medicine. Thirty percent or about 8 percent of total of those who talked to their doctor asked for a prescription, and 79 percent of those who asked for a prescription or about 5 percent of all Americans had their request honored.
Another survey found that roughly half of consumers who talked to their physician after seeing a DTCA ad were seeking treatment for the condition for the first time Weissman et al. Moreover, surveys show that most consumers view DTC ads positively. Only one-quarter of consumers surveyed in believed that prescription drug ads should be limited to medical journals read by physicians National Consumers League This marks a dramatic shift in the view of DTCA among regulators trying to balance the traditional emphasis on preventing misleading advertising with the goal of providing consumers with more information about possible treatments.
Even former FDA Commissioner David Kessler, who had opposed loosening the regulations to allow broadcast advertising throughout his term in office, recently recanted Mishra It was not until the time of HIV and cancer activism in the late s that the concept of patient empowerment really took hold.
And I think it is no coincidence that around that time we began to see, again, reemergence in the interest … in direct-to-consumer advertising. Several other forces were also active at that time. First, outcomes researchers had shown that patient values and preferences could drive the choice of appropriate treatment. These forces have resulted in a shift in the general societal perception of who needs what information. And of the dynamics of medical decision making in general.
The last few decades have seen a dramatic transformation of the consumer's role in health care, and DTCA and the policy debate surrounding it relate directly to this transformation. The current period of consumer involvement in health care harkens back to the drug market in the early twentieth century when self-treatment was highly valued and most drug advertising was aimed directly at consumers.
Physicians' authority over the prescribing of drugs has been directly challenged by DTC advertising campaigns urging consumers both to self-diagnose and to demand specific medications from their provider.
We therefore are not likely to return to the days when consumers were effectively cut off from commercial information about prescription drugs, nor are pharmaceutical companies likely to abandon their focus on physicians, who still control access to prescription drugs. ByNarcotic Thrust - Safe From Harm (CD) seemed to have weathered the deluge of criticism it encountered in the late s. Senate majority leader, William Frist a physiciancalled for a two-year voluntary moratorium on Narcotic Thrust - Safe From Harm (CD) use of DTCA for newly approved drugs Saul In addition, the FDA is continuing its decades-long effort to improve the communication of drug risks and benefits to consumers.
Because the FDA's authority is limited to approving drugs and it cannot decide the price purchasers will pay as similar agencies in other countries canthe policy debate over DTCA is mostly limited to its effect on drugs' safety and effectiveness. The impact of DTCA, and related trends in medical consumerism, on health care costs receives less attention. The history of consumerism and DTCA has important implications for other contemporary health policy debates.
The industry defined DTCA as a tool to enhance consumer choice and autonomy. Similarly, the industry has argued for consumer choice in prescription drug coverage policy in public insurance programs. Some state Medicaid policymakers have been reluctant to restrict access to costly psychotropic medications, in part because of vocal opposition from mental health consumer advocacy organizations.
Borrowing the language of consumer empowerment and choice, pharmaceutical manufacturers, which have a clear financial incentive to remove any restrictions on the use of their products, have supported mental health consumer groups in opposing cost-control mechanisms Harris But the industries' funding of consumer groups' advocacy efforts have called into question the authenticity of the consumers' perspective Tomes Long-standing skepticism of medical research financed by the pharmaceutical industry has been joined by concerns about alliances between the pharmaceutical industry and consumer advocacy groups.
Ethical issues surrounding these alliances have received less attention in the literature. The image of consumers as highly educated, technology savvy, and assertive strongly influences the current reshaping of health insurance arrangements in the public and private sectors. In the last few years, the health insurance industry has adopted new benefit, network, Narcotic Thrust - Safe From Harm (CD) management, and pricing policies in response to the demand from employers.
These contemporary policies highlight the insurers' shift away from cost containment through supply-side mechanisms that try to influence physicians' behavior in favor of policies that focus on the consumer side of the health care market Robinson Arguments in favor of shifting entitlement programs and employment-based health insurance away from defined benefit plans toward the use of medical savings account models will be more salient when accompanied by descriptions of informed consumers.
Indeed, the term defined contribution health plan has been replaced with consumer-driven health care planimplying that consumers exert considerable control over their insurance arrangements Shearer Health plans and purchasers are relying less on supply-side cost control mechanisms like restrictive provider networks and are focusing more on altering consumers' behavior, arming them with information at least in theory and stronger financial incentives to make prudent purchasing decisions.
The rhetoric of consumerism no doubt contributed to this transformation of the health insurance market. Legal and cultural changes in health care brought about by the patients' and consumers' rights movements laid the groundwork for the DTCA of prescription drugs. DTCA was surely an unintended consequence of these social movements and may, paradoxically, serve to frustrate future efforts to protect patients and consumers. That is, by shifting the rights and responsibilities for financing health care from government and private purchasers toward individual consumers, we are reducing the opportunities for public discourse on what health services should be covered and for whom Robinson Collective decisions about health care priority setting are being replaced by private health care choices.
Interestingly, countries with national health systems that delegate technology assessment and priority setting to governments have chosen not to allow the DTCA of prescription drugs. By arming consumers with more information about newer, more expensive treatments, the DTCA of prescription drugs and similar marketing efforts will likely foster continued resistance to centralized cost containment methods that explicitly limit the choices of consumers.
The author is grateful to Allan Brandt and Patricia Keenan for their insightful comments on earlier drafts of this article.
In addition, I would like to thank Bradford Gray and the three anonymous reviewers for their constructive comments. All errors are my own. For a discussion of these issues, see Hurwitz and Caves Before federal drug regulation, some states required consumers to obtain prescriptions for narcotics or poisons.
InCongress passed the Harrison Narcotics Act, which required consumers to obtain a prescription for narcotic drugs, but most other classes of drugs did not require a prescription until after National Center for Biotechnology InformationU.
Journal List Milbank Q v. Milbank Q. Julie Donohue. Author information Copyright and License information Disclaimer. University of Pittsburgh. This article has been cited by other articles in PMC. Keywords: Direct-to-consumer advertising, patients, consumers, rights, consumerism, prescription drugs, regulation, Food and Drug Administration, pharmaceutical industry. Mariner4 states that the law of patients' rights does not seek to give patients and physicians equal medical knowledge.
Federal Drug Regulation I begin my account of federal drug regulation in the early twentieth century for two reasons. The Context of Early Drug Regulation The federal regulation of drugs began when only a few effective drugs were on the market, and patients usually chose the medication themselves Shorter James Harvey Youngprovides examples of how patent medicine advertisers differentiated their treatments from those of doctors: Wherever regular physicians were weak, lo, there the nostrum maker was strong.
The Pure Food and Drugs Act Federal drug regulation began in the Progressive Era, during which a new faith in the scientific Narcotic Thrust - Safe From Harm (CD) and a belief in active, informed consumers reigned Pescosolido and Martin The Food, Drug, and Cosmetic Act By the s, federal drug regulators had abandoned the belief that consumers, armed solely with information about a drug's ingredients, could safely self-medicate.
Requiring Prescriptions: Durham Humphrey Amendments Beforethe categorization of a drug as available by either prescription or OTC was left up to the manufacturers, although the FDA did require some drugs to be sold by prescription only e. The Impact of Federal Policy on Pharmaceutical Marketing Between andfederal drug legislation and regulation had a significant impact on the market for drugs, and between andthe amount of money that consumers spent on drugs prescribed by doctors rose from 32 to 57 percent.
The following passage from a study of detailing conducted in the early s reveals physicians' reliance on detail men for information and the importance of personal relationships to the promotion of prescription drugs: With growing competition from similar or virtually identical products manufactured by different companies, the importance of favorable interpersonal relationships has become increasingly important. Rehder— Expanded Federal Regulation of Prescription Drugs When Congress expanded the federal government's regulatory authority over drugs in andit did not give the FDA authority over either over-the-counter or prescription drug advertising, because when it passed the Wheeler Lea Act init gave jurisdiction over drug advertising to the Federal Trade Commission FTC.
First, the regulations stated that advertisements broadcast through media such as radio, television, or telephone communications systems shall include information relating to the major side effects and contraindications of the advertised drugs in the audio or audio and visual parts of the presentation, and unless adequate provision is made for dissemination of the approved or permitted package labeling in connection with the broadcast presentation, shall contain a brief summary of all necessary information related to side effects and contraindications.
Informing the Patient The FDA's authority over prescription drug advertising expanded during a time in which physicians had nearly complete control over medical practice and in which prescription drug advertising directed at the public did not exist. Dawn of the Patients' Rights Movement The s also marked the beginning of the patients' rights movement, which sought certain legal protections for patients, in response to cases of abuse of human biomedical research subjects publicized in the s Katz Early DTC Campaigns The debate over PPIs during the late s raised the issue of consumers' awareness of prescription drugs, their uses, and their risks.
Concerns raised at the time were that DTCA would lead patients to pressure physicians to prescribe unnecessary or un-indicated drugs, increase the price of drugs, confuse patients by leading them to believe that some minor difference represents a major therapeutic advance, potentiate the use of brand name products rather than cheaper, but equivalent generic drugs and foster increased drug taking in an already overmedicated society.
Morris et al. Critical Views of DTCA An analysis of interest-group positions on DTCA in the early s shows significant resistance to greater consumer control over prescription drug use, by physicians' organizations, consumer groups, and even many in the pharmaceutical industry. Open in a separate window.
New Financial Imperatives From the s until the s, pharmaceutical firms promoted their products by influencing a learned intermediary—the physician. Consumerism in Health Care In addition to reacting to changes within the industry, pharmaceutical firms capitalized on a significant cultural change in the health care system that accelerated in the late s, one that emphasized the consumer's role in medical decision making. Total U. Wolfe Conclusion The last few decades have seen a dramatic transformation of the consumer's role in health care, and DTCA and the policy debate surrounding it relate directly to this transformation.
Acknowledgments The author is grateful to Allan Brandt and Patricia Keenan for their insightful comments on earlier drafts of this article. Endnotes 1 The economic literature does not agree on whether advertising serves to inform consumers, thereby improving the performance of the market, or to persuade consumers by altering their preferences, thereby undermining competition.
References Altman LK. New York Times. February Direct-to-Consumer Advertising of Prescription Drugs. Food and Drug Law Journal. The Truth about Drug Companies. New York: Random House; Uncertainty and the Welfare Economics of Medical Care. American Economic Review. Journal of Drug Issues. Agendas and Instability in American Politics.
Chicago: University of Chicago Press; Pennsylvania State University; [accessed July 27, ]. Lobbying Disclosure Data Set. Advocacy and Public Policy Making Project. Health Affairs. Journal of the American Medical Association. British Medical Journal. April Medical Marketing and Media. FDA Papers. A Right to Die? November 3.
Direct-to-the-Public Advertisement of Prescription Drugs. New England Journal of Medicine. Journal of Pharmaceutical Marketing and Management. Berkeley: University of California Press; Oral History Interview with Ken Feather.
Rockville, Md. Food and Drug Administration; May 7. Statement of Policy. September 2. Federal Register. Fox S, Fallows D. Washington, D. Internet Health Resources. Food and Drug Administration; [accessed July 27, ]. Oral History Interview with William W. Goodrich, Office of the General Counsel, — October Journal of Health Policy Politics and Law. Medical Authority and the Culture of Rights. Journal of Health Politics Policy and Law. December The Real Voice. New York: Macmillan; Physician and Public Attitudes.
Chicago: American Medical Association; February 4. Henney JE. Challenges in Regulating Direct-to-Consumer Advertising. Protecting America's Health. New York: Knopf; Persuasion or Information? Journal of Law and Economics. Journal of Industrial Economics. Promotional Spend by Type, Food and Drug Legislation in the New Deal. Princeton, N. Secret Nostrums and the Journal. June 2. Juhl RP. Clinical Therapeutics.
C :C— Academic Medicine. New York: Russell Sage; Food Drug and Cosmetic Law Journal. Henry J. Kaiser Family Foundation. Laine C, Davidoff F. Drug Company Advertising to the Public. Journal of Family Practice. Journal of Contemporary Health Law and Policy. Although our writing service is one of the cheapest you can find, we have been in the business long enough to learn how to maintain a balance between quality, wages, and profit.
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