Prescription Drug Industry Research Articles

Fourth Amendment Protections of Prescription Drug Monitoring Programs: Patient Privacy in the Opioid Crisis.

The opioid crisis is one of the largest public health problems in the history of the United States. Prescription drug monitoring programs ("PDMPs")-state databases containing the records of all prescriptions for controlled substances written in the state-have emerged as a means to track opioid prescribing and use. While PDMPs are typically used as a tool for physicians to inform their prescribing practices, many states also permit law enforcement to access PDMPs when investigating controlled substance distribution, often without prior judicial approval. Such law enforcement use of PDMPs raises serious questions of patient privacy. The Fourth Amendment protects individuals from unreasonable searches and seizures where they have a reasonable expectation of privacy and has been interpreted to require law enforcement have probable cause and a search warrant before infringing upon an individual's reasonable expectation of privacy. Several courts have held that patients have no reasonable expectation of privacy, or a severely diminished expectation of privacy, in their prescription drug records held in PDMPs. As support, courts rely on the third-party doctrine because the information is disclosed to physicians and then held by the state; the highly regulated nature of the prescription drug industry; and the statutory framework of the Controlled Substances Act. Such analysis disregards patients' expectation of privacy in their personal health information, the confidentiality in the physician-patient relationship, and the resulting patient incentives not to seek care. Therefore, this Article argues that law enforcement must have probable cause and a search warrant to access PDMPs because the exceptions to the Fourth Amendment's probable cause and warrant requirements do not apply.

Infringing on Investment: How One Company is Using Investment Protections of NAFTA to Save its Intellectual Property

In 1994, twenty years ago, the United States, Canada, and Mexico signed the North American Free Trade Agreement (“NAFTA”) into law.1 It had a number of goals, including the intent “to eliminate barriers of trade and investment between the United States, Canada and Mexico.”2 NAFTA has a number of provisions to achieve its goals, including decreasing the tariff between the three countries in order to increase trade.3 The decreasing tariff was intended to lower trade barriers with the hope of making consumer products cheaper.4 With respect to a number of consumer products, this hope was made into a reality.5 Importation from Mexican and Canadian factories without trade barriers made a number of goods, including automobiles, electronics, and clothing, cheaper in the United States.6 However, there is one area of consumer products that did not achieve the hoped for price decline in the United States: the prescription drug industry. There is a long-held belief in the United States that prescription drugs are made available at cheaper prices in countries such as Canada because of the availability of generic drugs.7 While this may not always be true in the cases of some prescription drugs,8 there is a basis for this claim.9

Law Enforcement as Legal Mobilization: Reforming the Pharmaceutical Industry Through Government Litigation

Scholars of legal mobilization have long explored how litigation is used as a resource for social and political change. While most studies focus on the actions of private groups, this article considers law enforcement as a form of legal mobilization. Employing a case study of recent pharmaceutical litigation, this article examines how prosecutors have mobilized the law to reshape corporate responsibilities in the prescription drug industry. Prosecutors' litigation campaigns have forced changes in organizational practices, expanded the scope of the conflict over pharmaceutical industry actions, and established new legal norms that have spread throughout the political system. This form of prosecutor‐led legal mobilization has occurred in other contexts as well, including gun control and mortgage lending. In addition to indicating how lawyers within the state can engage in a form of cause lawyering, the government litigation explored in this article illustrates both the instrumental and constitutive power of the law.

Influence of Pharmaceutical Promotional Tools on Doctors' Prescribing Behaviour: An Exploratory Study

The healthcare industry in general, and the prescription drug industry, in particular, employs an unusual combination of marketing and promotional efforts to influence the doctors who write the prescriptions that determine which drugs (brands) will be used by the ultimate consumer (patient). The involvement of doctors as key decision makers is the reason that they are the focus of most promotional efforts of pharmaceutical companies. Thus, influencing the doctor is a key to the pharmaceutical sales, and the pharmaceutical companies are spending a lot of money on marketing their products to the doctors. The present study examines the impact of promotional tools on doctors' prescribing behaviour. A total of 431 respondents were selected through convenience sampling from different cities of Rajasthan. The results show that the promotional factors which were found to be more influencing were the activities of the MR (medical representative), their rapport with the doctors, their personality traits, and the drug samples, leaflets, and brochures given by the MRs to the doctors. The findings are discussed in the light of past studies, and future directions for research are outlined.

Fishy Gifts: Bribing with Shame and Guilt

The following is a model of psychological contracting with unmonitorable performance, implicit offers, and screening for non-performance by the announcement of the expectation of performance. It is motivated by the $250 billion prescription drug industry, which spends $19 billion per year on marketing to US doctors, mostly on `gifts', and often, as at Yale, with no monitoring for reciprocation. In revealing incident, a drug firm representative closed her presentation to Yale medical residents by handing out $150 medical reference books and remarking, one hand washes the other. By the next day, half the books were returned. I model this with a shot psychological trust game with negative belief preferences and asymmetric information. I show that the `shame' of accepting a possible bribe can screen for reciprocation inducing `guilt'. An announcement can extend the effect. Current policies to deter reciprocation might aid such screening. I also discuss applications like vote buying when voting is unobservable and why taxis drivers in Naples announce inflated fares after their service is sunk.

Survival Skills for the Political Environment of Health Insurance

Blue Cross Blue Shield of Michigan asked the Michigan state government for small group market rate reform already adopted in most other states. Officials responded with major restructuring proposals aimed specifically at the Blues. The Michigan Blues fought back with a massive lobbying campaign as vigorous as any mounted by opponents of health reform at the national level. The company was able to prevail over one of the most powerful governors in Michigan history, whose party controlled both houses of the legislature. This amazing political victory shared much in common with the Clinton health reform's defeat by the industry and the more recent success of the prescription drug industry in shaping Medicare prescription drug reform to its liking. The experience suggests that political savvy and lobbying skills have become core competencies in the health care industry.

Economic Grand Rounds: Potential Effects of the New Medicare Drug Benefit on Pricing for Psychotropic Medications

The new Medicare Part D prescription drug benefit created by the Medicare Modernization Act of 2003 (MMA) will have sweeping effects on how prescription drugs, including psychotropic medications, are financed for seniors and individuals with disabilities. The MMA relies on private Part D plans to control benefit costs by negotiating discounted prices with drug manufacturers and using pharmacy management tools common in the private sector, such as tiered formularies, to control drug use and spending. However, the MMA may not result in large overall price discounts or cost savings for psychotropic medications because of unique characteristics of many of these drugs. Also, concern exists that the legislation could result in higher Medicaid prices for those not in Medicare and lower investment in research and development for psychotropic drugs in the future. In this column we describe key features of the new benefit and discuss these concerns.

Estimating allocative inefficiency in the prescription drug industry

The economic organization of the pharmaceutical industry is profoundly affected by the patent system, which provides a temporary monopoly as an incentive for innovation. The consensus of industry observers has been that potential benefits from stimulating pharmaceutical innovation are large and very difficult to estimate, while the costs of monopoly power are relatively modest. We argue that the use of accounting profits to estimate social costs of monopoly has led to serious underestimates of those social costs. In this paper we use sales estimates for individual drugs from survey data published by IMS America Ltd to estimate dead weight loss (DWL) per dollar of sales for several prescription drugs. We estimate that for the drugs we study there is $5 billion of DWL on the $8 billion of sales.

Haggling for a patent: what a government would have to pay for prescription drug patents.

In previous papers (Guell, R. and Fischbaum, M. The Milbank Quarterly 1995; 73: 2 and Applied Economics letters in press), we established that the allocative inefficiency in the prescription drug industry is so pervasive that some remedy is warranted. In the first paper, we estimated a lower bound on this inefficiency at approximately $3 billion, with an upper bound of approximately $30 billion; all on total industry sales of approximately $50 billion. In the second paper, on a narrower set of drugs for which sales were $8 billion, we more precisely estimated this dead weight loss to be $5 billion. From this we showed that a system could exist whereby a government would purchase a drug patent from a willing seller, freely distribute it and reap significant efficiency benefits. In those papers we considered the possibility that the innovating firm would not want to relinquish the patent, but we assumed that they would be indifferent between being paid the expected net present value of future monopoly profits and reaping those uncertain profits over time. While that may be the case, a more likely scenario would be that a negotiation would take place. In the current paper I show the bargaining range that would exist under different risk preference assumptions and show that this range widens as each side becomes more risk averse and narrows if the government threatens to use its power of eminent domain. Lastly, I acknowledge the risk of firms "capturing' the government agents doing the negotiation. To conclude, I present the circumstances under which the proposed agency would likely improve societal welfare and contrast that with the circumstances where the presently inefficient system would be made more so by government intervention.

Toward Allocative Efficiency in the Prescription Drug Industry

Traditionally, monopoly power in the pharmaceutical industry has been measured by profits. An alternative method estimates the deadweight loss of consumer surplus associated with the exercise of monopoly power. Although upper and lower bound estimates for this inefficiency are far apart, they at least suggest a dramatically greater welfare loss than measures of industry profitability would imply. A proposed system would have the U.S. government employing its power of eminent domain to "take" and distribute pharmaceutical patents, providing as "just compensation" the present value of the patent's expected future monopoly profits. Given the allocative inefficiency of raising taxes to pay for the program, the impact of the proposal on allocative efficiency would be at least as good at our lower bound estimate of monopoly costs while substantially improving efficiency at or near our upper bound estimate.

Bad Medicine: The Prescription Drug Industry in the Third World

Bad Medicine: The Prescription Drug Industry in the Third World

Rationing America's Medical Care: The Oregon Plan and Beyond, edited by Martin A. Strosberg, Joshua M. Wiener, Robert Baker and I. Alan Fein.

Book Reviews in this Article: Rationing America's Medical Care: The Oregon Plan and Beyond, edited by Martin A. Strosberg, Joshua M. Wiener, Robert Baker and I. Alan Fein. Bad Medicine: The Prescription Drug Industry in the Third World, by Milton Silverman, Mia Lydecker and Philip R. Lee. Stanford Feminist Perspectives in Medical Ethics, edited by Helen Bequaert Holmes and Laura M. Purdy, Bloomington and Indianapolis: Indiana Choices in Health Care: A Report by the Government Committee on Choices in Health Care, The Netherlands, 1992,

Bad medicine: the prescription drug industry in the third world

Bad medicine: the prescription drug industry in the third world

Bad Medicine: The Prescription Drug Industry in the Third World

Bad Medicine: The Prescription Drug Industry in the Third World

Book Review: Bad Medicine. The Prescription Drug Industry in the Third World

Book Review: Bad Medicine. The Prescription Drug Industry in the Third World

Bad medicine: the prescription drug industry in the Third World

Bad medicine: the prescription drug industry in the Third World

An Environmental Analysis of the Prescription Drug Industry

An Environmental Analysis of the Prescription Drug Industry

Physician and pharmacist perceptions of generic drugs

Generic prescribing and dispensing is increasingly being suggested as a means of limiting the rising costs of health care. However, general acceptance has been moderate despite efforts by the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and many state legislatures to encourage the use of generic drugs. This article describes the results of a study designed to explore physician and pharmacist concerns about generic drugs and their impact on the prescription drug industry. Results indicate that both groups are concerned about production quality and regulatory control across multiple manufacturers. Differences were found both within and between groups that could affect diffusion of generic practices. Implications are provided for marketing managers and others concerned with the changing environment within the prescription-drug industry.

Letter: Drug-induced illness.

<h3>To the Editor.—</h3> Talley and Laventurier stated that their earlier estimate of 30,000 deaths annually in the United States due to adverse drug reactions (ADRs) was too low, and that on the basis of new evidence, the number of such deaths ranges from 60,000 to 140,000 annually. The matter is of particular concern to the prescription drug industry since it has been suggested that companies, through overpromotion, are responsible for these deaths and hospital admissions. An attempt to trace the history of the 30,000 ADR death estimate, to review the pertinent literature, and to substantiate the 3,000 to 6,000 estimate follows. The issue has two parts: How many deaths occur annually because of adverse drug reactions, and to what extent can they be attributed to "promotional activities of the drug industry"? <h3>Background.—</h3> The history of the 30,000 statistic is convoluted. In a paper presented in August 1972 at Sea Island,

The Mail-Order Prescription Drug Industry

THE PRACTICE of mailing prescription and other medications to consumers in the United States probably had its origin in rural America. Before the general availability of the automobile, rural inhabitants often were dependent upon the U.S. mail for delivery of medicines and health supplies from their local pharmacy. This practice was not only a convenience to the consumer, but an essential health service as well-one in which physician, pharmacist, and patient were active participants. The Veterans Administration has used the mails for distributing medicines to its ambulant patients for many years. This practice was expanded greatly with the return of veterans after World War II and has continued to grow, proving convenient and economical for both parties. In more recent times, the National Retired Teachers Association and American Association of Retired Persons (NRTA-AARP) has been distributing prescription medications to its members through a program that is now a featured service. As the volume of prescriptions delivered by mail has increased, the practice has come under continuing, and at times critical, surveillance, particularly by organized pharmacy. Because available information to characterize the nature and extent of the mail-order prescription industry has not been collected and scrutinized, we undertook to assemble as much factual information as could be obtained. Professional organizations and State boards of pharmacy were contacted for the names of firms engaged in high-volume, mail-order distribution of prescription drugs. A list of approximately 60 organizations was compiled. Data were then collected through a combination of personal and telephone interviews from 10 of the larger organizations, using a standard set of questions relating to the data reported in the remainder of this paper. These organizations are responsible for approximately 90 percent of the volume of mail-order prescription drugs in the United States. This report constitutes a profile of the mail-order prescription drug industry as constructed from our study. For purposes of convenience, mail-order Dr. Wertheimer and Dr. Knoben were formerly on the stafi of the Pharmacy-Related Programs Branch, National Center for Health Services Research and Development, Health Resources Administration. Dr. Wertheimer is now associate professor, University of Minnesota College of Pharmacy; DP. Knoben is now at Yale University. Tearsheet requests to Dr. Albert I. Wertheimer, University of Minnesota College of Pharmacy, Minneapolis, Minn. 55455.