Pokemon Tort

'When Pokémon GO(es) Too Far: Augmented Reality and Tort Law' by Sara Gold in (2018) 38 Whittier Law Review comments

No one could have anticipated the drastic consequences of Pokémon GO, which quickly became the most popular smartphone game in U.S. history with more than $2 billion in global revenue from July 2016 to December 2018. 

In this augmented-reality game, players are required to travel with their phones to real-life locations in order to collect virtual Pokémon creatures and win rewards. The game, however, did not take precautions to avoid sending players to private property. As a result, homeowners nationwide began to suffer property damage, belligerence, and harassment from game players trespassing on their properties at all hours of the day and night. 

The resulting class-action lawsuit against Pokémon GO asked whether a game owner can be held liable for engineering a game in a manner encouraging other people to trespass

Schmitt

'The Schmitelsen Court: The Question of Legitimacy' by Or Bassok in German Law Journal (Forthcoming) comments

 In recent years, a new creature has emerged on the institutional landscape: the Schmitelsen Court. This Court is the end-product of a combination of the positions presented by Hans Kelsen and Carl Schmitt in their famous debate during the Weimar years on “Who is the Guardian of the Constitution?”. The Schmitelsen guardian is a court thus fulfilling Kelsen’s vision of the constitutional court as the guardian of the constitution. However, it possesses the mission, the means to achieve it, and the source of legitimacy that Schmitt envisioned for the president as the guardian of the constitution. In this Article, I focus on the Schmitelsen Court’s source of legitimacy that differs greatly from the traditional source of judicial legitimacy that Kelsen envisioned for the guardian. Whereas Kelsen viewed legal expertise as the guardian’s source of legitimacy, Schmitt viewed public support as filling this role. 

After analyzing these two positions, I explain why it is vital for the Schmitelsen Court to harness public support as its source of legitimacy. I proceed by examining how the Schmitelsen Court model manifests itself in three case studies. In the US, Alexander Hamilton in the Federalist No. 78 raised the notion of the guardian of the constitution long before Schmitt and Kelsen did so. He designated the judiciary as the guardian and ascribed expertise as its source of legitimacy. After describing how in recent decades the American Supreme Court adopted the Schmitelsen understanding of judicial legitimacy, I turn to examine the Israeli Supreme Court and the European Court of Human Rights. The relevance of these latter two courts stems not only from their adoption of the Schmitelsen Court’s understanding of judicial legitimacy, but also from the strong influence of the Weimar lessons on their evolution into a Schmitelsen guardian.

'Nationhood and Section 61 of the Constitution' by Peta Stephenson in (2018) Vol 43(2) University of Western Australia Law Review 149

 explores the relationship between the nationhood power and s 61 of the Constitution. It argues that, in the majority of decided cases, the nationhood power has not supported the Commonwealth Government engaging in coercive activities that would have been denied to it at common law. The key issue that has arisen in the case law has been whether an executive act fell within a subject matter of Commonwealth executive power. In this regard, the Court has found that Australia’s attainment of nationhood expanded the areas of Commonwealth responsibility over which the executive power could be exercised. It is further shown that the nationhood power has not undermined the federal distribution of powers. The Court has, in ascertaining whether an executive act is supported by the nationhood power, consistently applied Mason J’s ‘peculiarly adapted’ test, which was set out in Victoria v Commonwealth and Hayden (‘AAP Case’). This test incorporates federalism to condition and limit the nationhood power.

Stephenson comments

Section 61 is the principal repository of Commonwealth executive power in the Constitution. It vests the executive power of the Commonwealth in the Queen and states that it is exercisable by the Governor-General and ‘extends to the execution and maintenance of this Constitution, and of the laws of the Commonwealth’. Section 61 ‘marks the external boundaries’ of Commonwealth executive power but does not define it. The meaning of s 61 can only be properly understood if it is considered in the light of British constitutional history, conventions and the common law. 

Consistent with our British heritage, it is now generally accepted that, in addition to executive powers sourced directly in the Constitution and conferred by statute, s 61 incorporates all of the common law or ‘non-statutory’ powers of the Crown that are appropriate to the Commonwealth, subject to the federal distribution of powers effected by the Constitution. In a classification that has since received judicial endorsement, Sir William Blackstone divided the common law powers into two categories, namely, the prerogative powers and capacities of the Crown. The ‘prerogative’ was understood as referring to ‘those rights and capacities which the King enjoys alone, in contradistinction to others, and not to those which he enjoys in common with any of his subjects’, such as the power to declare war and peace, enter into treaties and confer honours. ‘Capacities’, on the other hand, were those powers that the Crown shared in common with its subjects. Of the Crown’s common law capacities, the power to contract and spend has received the most judicial consideration in recent years, following a spate of High Court challenges to controversial Commonwealth spending programs. 

In Victoria v Commonwealth and Hayden (‘AAP Case’), four Justices of the High Court confirmed that the executive power in s 61 also incorporated an implied executive power derived, in part, from Australia’s national status. Mason J gave the most precise formulation of it, describing it as ‘a capacity to engage in enterprises and activities peculiarly adapted to the government of a nation and which cannot otherwise be carried on for the benefit of the nation’. This aspect of the executive power has been described as the ‘inherent power’,or ‘implied national power’. More commonly, scholars have referred to it as the ‘nationhood power’, notwithstanding that, until fairly recently, this description was not adopted by a majority of the High Court of Australia. 

Which Law School

Ivy, mill or otherwise in the US? Analyzing Law School Choice' (AccessLex Institute Research Paper No. 19-01) by CJ Ryan comments 

The contemporary crisis in law school enrollments presents a timely opportunity to evaluate a subject that has received little academic attention: student choice in legal education. In order to address the present lack of understanding about what motivates post-Recession law students to enroll in law school, this article examines several of the factors that bear on the choice to attend law school from the results of an original survey distributed to current law students at a four law schools—a private elite law school, a public flagship law school, a public regional law school, and a private new law school—in the 2017–2018 academic year. This article analyzes the salience of location, information, opportunity cost, and cost sensitivity in the context of a law student’s decision to enroll in law school. The results from this survey indicate that legal education is a highly stratified market for consumers on the basis of their preferences. It is hoped that these results will shed greater light on and knowledge of the most understudied group in professional graduate education—law students.

Ends

'Artificial Intelligence Based Suicide Prediction' by Jason Marks in Yale Journal of Health Policy, Law, and Ethics (Forthcoming) comments 

 Suicidal thoughts and behaviors are an international public health concern contributing to 800,000 annual deaths and up to 25 million nonfatal suicide attempts. In the United States, suicide rates have increased steadily for two decades reaching 47,000 per year and surpassing annual motor vehicle deaths. This trend has prompted government agencies, healthcare systems, and multinational corporations to invest in tools that use artificial intelligence to predict and prevent suicide. This article is the first to describe the full landscape of these tools, the laws that apply to their operation, and the under explored risks they pose to patients and consumers. 

AI-based suicide prediction is developing along two separate tracks: In “medical suicide prediction,” AI analyzes data from patient medical records; In “social suicide prediction,” AI analyzes consumer behavior derived from social media, smartphone apps, and the Internet of Things. Because medical suicide prediction occurs within the healthcare system, it is governed by laws such as the Health Information Portability and Accountability Act (HIPAA), which protects patient privacy; regulations such as the Federal Common Rule, which protects the safety of human research subjects; and general principles of medical ethics such as autonomy, beneficence, and justice. Moreover, medical suicide prediction methods are published in peer-reviewed academic journals. In contrast, social suicide prediction typically occurs outside the healthcare system where it is almost completely unregulated, and corporations often maintain their prediction methods as proprietary trade secrets. Due to this lack of transparency, little is known about their safety or effectiveness. Nevertheless, unlike medical suicide prediction, which is primarily experimental, social suicide prediction is deployed globally to affect people’s lives every day. 

Though AI-based suicide prediction may improve our understanding of suicide while potentially saving lives, it raises many risks that have been under explored. The risks include stigmatization of people with mental illness, the transfer of sensitive health data to third-parties such as advertisers and data brokers, unnecessary involuntary confinement, violent confrontations with police, exacerbation of mental health conditions, and paradoxical increases in suicide risk. After describing these risks, the article presents a policy framework for promoting safe, effective, and fair AI-based suicide predictions. The framework could be adopted voluntarily by companies that make suicide predictions or serve as a foundation for regulation in the US and abroad.

'Abolishing the Suicide Rule' by Alex B Long in (2019) 115(4) Northwestern University Law Review comments

Suicide is increasingly recognized as a public health issue. There are over 40,000 suicides a year in the US, making suicide the tenth-leading cause of death in the country. But societal attitudes on the subject remain decidedly mixed. Suicide is often closely linked to mental illness, a condition that continues to involve stigma and often triggers irrational fears and misunderstanding. For many, suicide remains an immoral act that flies in the face of strongly held religious principles. In some ways, tort law’s treatment of suicide mirrors the conflicting societal views regarding suicide. Tort law has long been reluctant to permit recovery in a wrongful death action from a defendant who is alleged to have caused the suicide of the decedent. In many instances, courts apply a strict rule of causation in suicide cases that has actually been dubbed ‘the suicide rule’ in one jurisdiction. While reluctance to assign liability to defendants whose actions are alleged to have resulted in suicide still remains the norm in negligence cases, there has been a slight trend among court decisions away from singling out suicide cases for special treatment and toward an analytical framework that more closely follows traditional tort law principles. This Article argues that this trend is to be encouraged and that it is time for courts to largely abandon the special rules that have developed in suicide cases that treat suicide as a superseding cause of a decedent’s death.

Property

'Valuing Emotions' by Hila Keren in (2018) 53(5) Wake Forest Law Review comments

This Article illuminates an unresolved legal enigma: Why is private law so reluctant to compensate victims for emotional harms while it is fully committed to compensating them for any other type of harm? It proposes a novel analysis of the deeper roots of the problem and a solution. This Article shows that the persistent resistance to compensation in the affective domain comes from a broader legal misunderstanding and mistreatment of emotions. Opponents of compensation are wrong to assume that emotional harms are trivial, easy to fake, or impossible to value. Rather, with the help of scientific and technological progress, it should be clear by now that the devaluation of emotional harms is unjustified, injurious to victims, and toxic to relational norms of behavior. What’s worse, as this Article exposes, is that while the debate has continued without resolution, reality has dramatically changed. Outside of law and under a neoliberal worldview, the value of emotions has been celebrated, making emotions a new type of personal property and an important component of people’s human capital. The Article thus demonstrates that in today’s hypercompetitive world the refusal to compensate for emotional harms is more devastating than ever before. For that reason the Article proposes that it is about time we start valuing emotions – recognizing their importance and compensating those who suffered emotional harms. The Article then discusses how to shape the necessary reform, mainly by utilizing existing remedial tools to cope with concerns related to verification and measurement – a challenge that is in no way unique to emotional harms and should not continue to prevent appropriate compensation.

'The Street View of Property' by Vanessa Casado Perez in (2019) 70(2) Hastings Law Journal 367-408 comments 

Parking on public streets is scarce. The current allocation system for parking spots based on the rule of capture coupled with low parking fees creates a tragedy of the commons scenario. The misallocation of parking has consequences for commerce, for access to public spaces, and for pollution and congestion. Municipalities have not widely adopted the solution that economists propose to solve this scarcity problem: increase the price. Politics aside, the reluctance of municipalities to do so may be explained by the unique nature of public property as reflected in well-rooted legal and societal constraints. This unique nature helps explain, for example, municipalities’ ban on software applications (apps) allowing occupants of curbside parking to “sell” their spots to would-be occupants in Boston or San Francisco. While the ban may be justified, the unique nature of public property is not incompatible with some well-designed, efficiency-oriented policies, as this Article will put forward. 

This Article distills the legal constraints on curbside parking and any other public property management by drawing on case law regarding parking meters and public resources managed in trust for the public, and decisions by municipalities regarding parking apps and privatization of parking meters. These constraints include, among others, that public property shall not be used to raise revenue, although placing a price on it may pursue other regulatory aims consistent with public use, or that municipalities shall not lose control of the public spaces dedicated to curbside parking. At a normative level, the above constraints provide a framework for assessing policies regarding curbside parking and, by extension the management of any other public property resources. At a positive level, the Article proposes ways to make efficiency compatible with the principles guiding the management of public property. It analyzes whether, and to what extent, the efficiency-oriented policies that would translate into a price increase—variable pricing, tradable property rights, and privatization—clash with those principles constraining the monetization of public property. In addition, the Article concludes by pointing to other situations where its analytical framework could be extended, such as other uses of public streets (for instance, use of public bus stops by shuttle-buses of private companies) or existing practices in connection to public resources (for instance, semi-privatization of beaches).

Suffrage

Voting Rights and Australian Local Democracy' by Ryan Goss in (2017) 40 University of New South Wales Law Journal 1008 comments 

 In five of Australia’s six States, legislation governing the franchise at local government elections allows for voting rights based partly on property ownership or occupation, for votes for corporations, and for various forms of plural voting. There is no existing comprehensive nationwide catalogue and analysis of the legislation that underpins this phenomenon. This article fills the gap in the literature by providing that analysis. Part I provides a concise overview of the historical context in Britain and in Australia. Part II is the central contribution of the article, describing and analyzing the legislation across the six Australian States. Part II demonstrates the idiosyncratic complexity of local government franchises within and across the States. While this article’s primary goal is to critique the legislation as it stands, Part III concisely makes the case for reform of voting rights at local government elections, suggesting that the status quo raises concerns about democratic inequality.

"Foot Voting and the Future of Liberty" by Ilya Somin in Todd Henderson (ed), The Cambridge Handbook of Classical Liberal Thought (Cambridge University Press, 2018) comments

 One of the major goals of libertarianism – and liberalism generally – is expanding political freedom: the opportunity to exercise meaningful choice over the government policies we live under. The main opportunity for political choice in modern liberal democracies is ballot box voting. Despite some genuine virtues, it has serious flaws as a mechanism for enhancing political freedom. The average citizen has almost no chance of affecting the outcome of an electoral process. In part as a result, he or she also has strong incentives to make ill-informed and illogical decisions. We can do better on both fronts when we “vote with our feet.” 

Part I of this chapter briefly outlines three types of foot voting: voting with your feet between jurisdictions in a federal system, foot voting in the private sector, and international migration. All three involve meaningful exercises of political choice. In Part II, I explain how foot voting is superior to ballot box voting as a mechanism of political freedom. It allows for more meaningful and better-informed choice. It is also superior from the standpoint of several leading accounts of political freedom: Consent, negative liberty, positive liberty, and nondomination. 

Part III considers objections to foot voting based on theories of self-determination, under which current residents of a given territory have a right to exclude newcomers in order to protect the political freedom of the former. Such theories come in both group-oriented and individualistic variants. Group theories posit that certain groups have a right to exclude newcomers based on their ethnic, racial, or religious characteristics. Individualistic theories claim that current residents can exclude newcomers for much the same reasons that private property owners or members of a private club have a right to exclude. I argue that both types of claims have severe flaws. Part IV discusses some institutional reforms that can help expand foot voting opportunities, while mitigating potential downsides. Finally, the Conclusion briefly suggests some ways in which expanded foot voting can help brighten future prospects for promoting libertarian values.

Belted

The short 'China, 'Belt and Road' and Intellectual Property Cooperation' by Peter Yu in (2019) 14 Global Trade and Customs Journal comments 

In fall 2013, China launched the "One Belt, One Road" Initiative, covering over 60 percent of the world's population and about a third of global GDP. Now translated officially as the Belt and Road Initiative (BRI), this new development features two distinct routes: the land-based Silk Road Economic Belt and the sea-based 21st-century Maritime Silk Road. 

Although burgeoning literature has emerged to analyze the BRI's benefits, drawbacks and ramifications, few scholars have explored the initiative's potential impact on international and regional intellectual property systems. Commissioned for a special issue on the BRI, this article aims to fill this void by examining the emerging role China and its BRI will play in the intellectual property area. 

This article begins by exploring China's growing assertiveness in the international arena. It then explores six areas in which the BRI can play constructive roles in facilitating international and regional cooperation on intellectual property matters. Recognizing that this initiative has generated many concerns and complications, the article concludes by addressing three oft-raised questions relating to the initiative.

Medications Pipeline

'Drug discovery in jeopardy' by Pedro Cuatrecasas in (2006) 116(11) The Journal of Clinical Investigation 2837–2842 comments

Despite striking advances in the biomedical sciences, the flow of new drugs has slowed to a trickle, impairing therapeutic advances as well as the commercial success of drug companies. Reduced productivity in the drug industry is caused mainly by corporate policies that discourage innovation. This is compounded by various consequences of mega-mergers, the obsession for blockbuster drugs, the shift of control of research from scientists to marketers, the need for fast sales growth, and the discontinuation of development compounds for nontechnical reasons. Lessons from the past indicate that these problems can be overcome, and herein, new and improved directions for drug discovery are suggested. 

Cuatrecasas argues that

 The decreasing output of new drugs and the drying up of industry pipelines are well established (1–4). To maintain profitability, the pharmaceutical industry has resorted to practices that have drawn public criticism, including markedly increasing drug prices, increasing spending on advertising and promotion, direct-to-consumer advertising, ineffectively conducting postmarketing surveillance, and limiting comparative efficacy/safety studies with alternative drugs. However, attention should be directed more to the root of these problems — the inefficiencies of drug discovery and development (D&D), which result from the management policies and corporate cultures of the institutions (corporations) that undertake the research and development (R&D). These conditions are so entrenched that we must ponder whether the current system can recover. 

What is really wrong? 

Low productivity. 

The low productivity (1–4) of drug D&D is certainly not related to available budgets, which have increased 30-fold since 1970. Many Pharmas devote more than $5 billion/year to R&D, with over $30 billion/year of cumulative spending, greater that the total NIH budget of $28 billion. The falling productivity has been ascribed commonly to a number of well-discussed factors such as regulatory hurdles and high attrition of drug candidates (1–4). Most of these issues are contributory rather than fundamental; at the heart of the problem are the more profound underlying dynamics that drive R&D.

The FDA oversees drug development and approval of new drug applications (NDAs). While the regulatory requirements are well warranted, grossly inadequate resources (5) have resulted in an antiquated process of NDA review that is slow, sometimes of poor quality, and at times subject to political influence. Other issues include the retraction of agreed-upon requirements for approval, the current crisis of FDA leadership (e.g., absence of a permanent commissioner), and the inappropriate role of ideology in decision-making (e.g., the case of approval for the “morning-after” pill). Other critiques can be found elsewhere (e.g., in refs. 1–4 and 5–8). Although significant reforms are in order, the FDA or regulatory issues are not fundamental barriers and contribute only marginally to the decline in drug productivity.

Likewise, we cannot blame the current state of scientific advances, which in the last 20 years have been revolutionary. These advances offer mind-staggering new opportunities in innovative drug discovery and development. It is also fallacious to suggest that the decrease in new drugs is due to our already having conquered the “easy” diseases, a rationalization repeatedly expressed for 3 decades.

The complex, lengthy, and unpredictable nature of drug R&D certainly contributes significantly to high costs and inefficiencies. For example, only 1 or 2 of every 10 compounds entering the phase of human clinical trial ever reaches the market. However, this high rate of loss of drug candidates during development (i.e., attrition) is not greater today than in past decades. As will be elaborated, the current problem of low productivity relates instead primarily to the pervasive mismanagement of the already difficult R&D process.

Changes in the approach to management.

Foremost among the issues that cripple drug R&D is that while utmost creativity and innovation are required, the R&D is conducted in traditional for-profit corporations that are virtually indistinguishable operationally from those that conduct little or no R&D. Most corporations’ top management does not understand the complexities of science, its mode of conduct or objectives, and runs the companies in ways that stifle creativity and innovation (9, 10). Prior to 1980, most drug companies functioned differently. They were smaller than today’s companies, and the nontechnical executives knew and were proud of their scientists and were more likely to allow R&D staff to pursue objectives with little interference. Informal systems dominated behavior. Each company had its unique ways, history, character, and culture. Most appreciated that their existence and fortunes were based on a combination of need and economic benefit, such that profitability was balanced with public responsibility. This tended to minimize the overpricing of drugs. A corporate identity of (and pride in) uniqueness of purpose were evident. Employees felt they were contributing to the improvement of human health.

In the 1970s things began to change. Modern managers entered as chief executive officers (CEOs) and other high-level executives, mostly with little or no technical experience. Many had legal or business school training or came from non-drug industries that functioned with greater organizational discipline. Those promoted internally were often from legal or finance departments, with little or no experience in research, manufacturing, or engineering. Most were unacquainted with research and were uncomfortable with seemingly “unfocused” research organizations that they perceived to operate in a freewheeling, independent style. These executives found comfort in outside management consulting firms that were called upon to suggest structural reshapings and behavioral changes. Corporate management had an instrument by which to introduce order into the research establishments (10).

Unfortunately, while consulting firms had experience in advising non–technology-based corporations, few were familiar with drug companies or complex professional-based matrix organizations. Their recommendations to change organizational structures, procedures, and even program and project portfolios were patterned after companies with which they were familiar, such as General Electric and other so-called well-managed companies. Use of these consulting firms became so fashionable that virtually every Pharma underwent similar externally driven reshaping in an effort to manage and control its scientific enterprise. Further, by popularizing “benchmarking,” a process in which companies review their activities against what others are doing, rather than exploiting their own unique skills and experience, drug companies began to all look alike (10).

Conformism.

With such restructuring, drug companies now felt more confident that they could manage and mandate results with discipline, order, formality, and efficiency. Unfortunately, many of these qualities are ones that suffocate creativity and innovation. Freedom, spontaneity, flexibility, nimbleness, tolerance, compassion, humor, and diversity were replaced by bulky and inflexible organizational structures characterized by regimentation, control, conformity, and excessive bureaucracy. Managers often overfocused and employed top-down decision-making (10). The objective outcomes resulted in more mediocre, not novel, products, and there was no evidence of improved long-term profitability. Ironically, great-sounding slogans were used to achieve conformity while proclaiming the importance of innovation, empowerment, diversity, and compassion.

Managers, not leaders.

It is understandable that most corporate human resources departments are unaware of some of these issues. However, top research managers can unfortunately be similarly uninformed. Most rise through the ranks by satisfying superiors and are selected by nontechnical management (and human resources programs) as “good company players.” While outstanding scientists are often recruited for high leadership roles in research, the “learn about industry” education process and lure of power can ultimately result in an intellectual shortsightedness regarding science. For some, the financial incentives are important. Of course, many of the best-qualified who cannot adjust depart quietly, while others find ways to quixotically manage the system and foster creative environments and research programs. There are still companies that try to focus on excellent science and that attract first-rate scientists. These are, however, exceptional situations.

Drug R&D thrives in a creative, flexible, and nonautocratic environment (9). Success depends on individual freedom and inspiration rather than dogmatic leadership. Instead, in “well-run” corporations today, scientists must contend with “management by objectives,” hierarchical and autocratic organizations, mandates from strategic planning groups, detailed and rigid scheduling, constant reporting, and achievement driven by milestones and flowcharts. Normally, rewards are based on quantitative output (number and weight of reports or numbers of compounds or tests) and extrinsic incentives such as money, promotion, power, and visibility. Is it any wonder that true innovation cannot thrive?

Pressures from shareholders.

The ownership of public companies consists mainly of shareholders who expect rapid (and substantive) returns on their investments. This contrasts (and often conflicts) with the nature of the business objectives, which must be based on long-term investments in science and technology. This dilemma is illustrated by the requirements for quarterly reporting of earnings versus the 10- to 20-year cycles of business operations (product projects). Companies have managed to navigate through this quandary, but it is becoming increasingly difficult.

Shareholders, investment bankers, and analysts, who know little about drug discovery, place intense pressures on CEOs and their boards for quick returns. Boards of directors, although often understanding of the CEOs’ dilemma, are nevertheless forced (by their primary role of representing the interests of shareholders) to push CEOs by setting stringent, short-term financial performance outcomes for determining annual compensation. CEOs are thus under even more pressure to achieve quick results through cost-cutting, low-risk projects, and acquisitions. All too rarely, an enlightened CEO undertakes energetic efforts to educate boards and analysts regarding the nature of their business and to insist that responsibility and accountability to the public are paramount concerns that demand a long-term view and, perhaps, profit expectations more in line with those of other industries.

Merger mania.

The decreasing earnings of Pharmas have stimulated mergers and acquisitions, driven by the desire to acquire existing sales (products) while decreasing costs via layoffs. This has created conditions that catalyze further inefficiencies and suffocation of innovation. The merged megacompanies’ research organizations must be integrated rapidly and redundancies eliminated, oftentimes in haste. Decisions regarding people and programs are made arbitrarily, by people far removed from the science and labs. Good programs are eliminated in attempts to consolidate, and knowledge, training, and expertise, often cultivated over many years, are often lost. Active scientists can be transferred to administrative, nonscientific tasks such as project management, licensing, and planning. While these posts often appear glamorous, such appointments can remove the individual from the scientific arena and result in the loss of valuable expertise to the company.

With rapid growth and huge size come changes in bureaucratic procedures and organizational hierarchies that may be confusing or meaningless to individuals (9). Communication, so important in complex scientific undertakings dependent on teams and matrix interactions, becomes burdensome. The dispersion of personnel and projects over geographic regions or buildings is also disruptive.

Blockbuster mania.

Pharmas have become much less interested in developing drugs that will sell less than $1 billion a year. Without these “blockbusters” they cannot maintain the traditionally high profits. The loss of major drugs to patent expiration, the high-gross sales required, and the increasing costs of R&D and of advertising, promotion, and marketing require sustaining a sizable number of highly profitable new products. The larger the existing sales, the greater the need for blockbusters.

To optimize the economic potential of new blockbuster drugs, it is necessary that, once they are marketed, the rate of sales growth be as high as possible. The “front-end” upswing benefit is due to the current value of money, maximizing patent periods, preparing for emerging competition, and the inherent promotional value of the rapid growth itself. This is so important that many corporations now even deliberately delay NDAs or marketing itself until they can amass as impressive a promotional “package” as possible. This may include studies that support other clinical indications and dosage forms, marketing support, and economic data on other “benefits,” such as formularies and reimbursement.

This approach contrasts with the practices of 20–30 years ago. The rationale then was to initiate marketing more quietly with whatever was necessary to receive FDA approval and to expand the franchise gradually but solidly over ensuing years with follow-up studies and analyses based on experience. The medical community was perceived as being cautious with new medicines. The drug’s labeling was revised frequently over time to reflect new indications and dosage forms, side effects, warnings, and contraindications. This approach also helped create longer-lasting brand loyalty, very important in the days before automatic generic substitution on patent expiration. The economic value of new drugs was initially lower, but it increased and was spread over many years.

A danger of today’s exceedingly aggressive introduction of new drugs into the marketplace is that it is virtually impossible to obtain postmarketing data from pharmacovigilance programs. Thus, it is more likely that unexpected, serious adverse events will be discovered only after millions of drug exposures. In recent years many drugs have been withdrawn suddenly from the market, under duress, due to such unexpected and serious side effects.

Infrequent but serious adverse events can arouse significant public attention and turmoil. There is little time to scientifically evaluate possible contributing factors. The media’s quest for sensationalism helps create a frenzy of emotion, misinformation, and accusations. It is nearly impossible to rationally resolve complex scientific issues under this type of public scrutiny. Thus, in many cases the only alternative is to take the drug off the market. This can be calamitous for the company as well as those patients who have suffered or who received major benefits from the drug. Many of the adverse events reported are clearly causally related, but attribution in other cases may be questionable. In most cases the stigma of incrimination and market withdrawal is such that no matter what the facts turn out to be, marketing cannot be restored.

Another risk of overzealous development planning for blockbuster status is that unexpected clinical or regulatory “problems” that always arise can become sufficiently discouraging to derail the drug altogether; expectations are not met, and the blockbuster status is compromised. Clearly, to better serve public safety and instill scientifically valid decision-making, and improve the long-term interests of corporations and shareholders, better systems of postmarketing surveillance are needed. But this is probably not possible without more deliberate and cautious marketing of new drugs. 

The shift from R&D to marketing.

The decision that a company cannot waste resources on non-blockbuster drugs often leads to unwise decisions. Marketing departments, almost by definition, must control R&D. They decide, ultimately, which research programs, diseases, indications, characteristics, and development compounds to pursue. Marketers rarely have interest in early-stage compounds with novel mechanisms or in unfamiliar clinical indications. They often push to discontinue (or not license-in) programs based on unsupportable commercial extrapolations, to the great frustration of scientists.