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Summary. Drug shortages and increasing generic drug prices are associated with low levels of competition. Mergers and acquisitions impact the level of competition. Record merger and acquisition activity was reported for the pharmaceutical sector in 2014/15, yet information on mergers and acquisitions in the generic drug sector are absent from the literature. This information is necessary to understand if and how such mergers and acquisitions can be a factor in drug shortages and increasing prices. METHODS: Data on completed merger and acquisition deals that had a generic drug company being taken over (i.e. 'target') were extracted from Bloomberg Finance L.P. The number and announced value of deals are presented globally, for the United States, and globally excluding the United States annually from 1995 to 2016 in United States dollars. RESULTS: Generic drug companies comprised 9.3% of the value of all deals with pharmaceutical targets occurring from 1995 to 2016. Globally, in 1995 there were no deals, in 2014 there were 22 deals worth $1.86 billion, in 2015 there were 34 deals totalling $33.56 billion, and in 2016 there were 42 deals worth in excess of $44 billion. This substantial increase was partially attributed to Teva's 2016 acquisition of Allergan's generic drug business. The surge in mergers and acquisitions for 2015/16 was driven by deals in the United States, where they represented 89.7% of the dollar value of deals in those years. CONCLUSIONS: The recent blitz in mergers and acquisitions signals that the generic drug industry is undergoing a transformation, especially in the United States. This restructuring can negatively affect the level of competition that might impact prices and shortages for some products, emphasizing the importance of updating regulations and procurement policies.

Summary. Investigates strategies for regulating inappropriate faculty consulting relationships. This was my Safra project.

Summary. Like all physicians, radiologists in the United States are subject to frequent and costly medical malpractice claims. Legal scholars and physicians concur that the US civil justice system is neither precise nor accurate in determining whether malpractice has truly occurred in cases in which claims are made. Sometimes, this inaccuracy is driven by biases inherent in medical expert-witness opinions. For example, expert-witness testimony involving "missed" radiology findings can be negatively affected by several cognitive biases, such as contextual bias, hindsight bias, and outcome bias. Biases inherent in the US legal system, such as selection bias, compensation bias, and affiliation bias, also play important roles. Fortunately, many of these biases can be significantly mitigated or eliminated through the use of appropriate blinding techniques. This paper reviews the major works on expert-witness blinding in the legal scholarship and the radiology professional literature. Its purpose is to acquaint the reader with the evidence that unblinded expert-witness testimony is tainted by multiple sources of bias and to examine proposed strategies for addressing these biases through blinding.

Summary. The law has long been concerned with the agency problems that arise when advisors, such as attorneys or physicians, put themselves in financial relationships that create conflicts of interest. If the financial relationship is "material" to the transactions proposed by the advisor, then non-disclosure of the relationship may be pertinent to claims of malpractice, informed consent, and even fraud, as well as to professional discipline. In these sorts of cases, materiality is closely related to the question of causation, roughly turning on whether the withheld information might have changed the decision of a reasonable advisee (i.e., a patient). The injured plaintiff will predictably testify that the information would have impacted his or her choice, but that self-serving testimony may be unreliable. The fact finder is left to speculate about the counterfactual world in which the information was disclosed. This Article shows how randomized vignette-based experimentation may create a valuable form of evidence to address these questions, for both litigation and policymaking. To demonstrate this method and investigate conflicts of interest in healthcare in particular, we recruited 691 human subjects and asked them to imagine themselves as patients facing a choice about whether to undergo a cardiac stenting procedure recommended by a cardiologist. We manipulated the vignettes in a 2 x 3 between-subjects design, where we systematically varied the appropriateness of the proposed treatment, which was described in terms of patient risk without the procedure (low or high), and manipulated the type of disclosure provided by the physician (none, standard, or enhanced). We used physician ownership of the specialty hospital where the surgery would be performed as the conflict of interest, disclosed or not, and the "enhanced" disclosure included notice that such relationships have been associated with biases in prescribing behavior. We found that the mock patients were significantly less likely to follow the cardiologist's recommendation of surgical implantation of a drug-eluting stent when he disclosed a financial conflict of interest, regardless of whether the disclosure was standard or enhanced. We also found that the mock patients were more likely to choose the treatment when they faced greater risk without it. We did not, however, find that the disclosure made patients more discerning about the appropriateness of the procedure. We discuss the implications for law and policy. Mock patients seem likely to act upon such information, declining the low-value healthcare when conflicts are disclosed. This finding suggests that the information is material to such transactions, and that disclosures may be salutary for medical decisions. Arguably, therefore, physicians already have a duty under the common law to disclose the financial relationships they choose to accept. Other regulators and policymakers should recognize and clarify this duty, and courts should embrace this form of evidence. Methodologically, although this empirical approach has limits, it reduces speculation by fact finders and policymakers, by at least focusing their attention on the right questions.

Summary. The dominant business model of the pharmaceutical sector is based on the massive promotion of drugs that often do not represent any significant therapeutic advance. Clinical research is therefore run like a promotional campaign. The data obtained from clinical research are primarily used to boost and support sales rather than to improve prescribing behaviour. Three common and widely used corporate strategies are used to this end: ghostwriters are employed to inflate the number of publications showing the drug in a positive light; results that would harm sales are not published (publication bias); and negative data are suppressed, sometimes going as far as to intimidate troublesome independent academics and whistle-blowers. The objective of these strategies is to enable the new drug to gain market share from its competitors. If medicine is to progress, research must be more independent and freed from the commercial imperatives of the pharmaceutical industry.

Summary. This paper explores the empirical evidence regarding the impact financial relationships on the behavior of health care providers, specifically, physicians. We identify and synthesize peer-reviewed data addressing whether financial incentives are causally related to patient outcomes and health care costs. We cover three main areas where financial conflicts of interest arise and may have an observable relationship to health care practices: (1) physicians' roles as self-referrers, (2) insurance reimbursement schemes that create incentives for certain clinical choices over others, and (3) financial relationships between physicians and the drug and device industries. We found a well-developed scientific literature consisting of dozens of empirical studies, some that allow stronger causal inferences than others, but which altogether show that such financial conflicts of interests can, and sometimes do, impact physicians' clinical decisions. Further research is warranted to document the causal relationship of such changes on health outcomes and the cost of care, but the current base of evidence is sufficiently robust to motivate policy reform.