Structure of the module of vector-valued modular forms

Let $V$ be a representation of the modular group $\Gamma$ of dimension $p$. We show that the $\mathbb{Z}$-graded space $\mathcal{H}(V)$ of holomorphic vector-valued modular forms associated to $V$ is a free module of rank $p$ over the algebra $\mathcal{M}$ of classical holomorphic modular forms. We study the nature of $\mathcal{H}$ considered as a functor from $\Gamma$-modules to graded $\mathcal{M}$-lattices and give some applications, including the calculation of the Hilbert-Poincar\'{e} of $\mathcal{H}(V)$ in some cases

Biosupremacy: Big Data, Antitrust, and Monopolistic Power Over Human Behavior

Since 2001, five leading technology companies have acquired more than 600 other firms while avoiding antitrust enforcement. By accumulating technologies in adjacent or unrelated industries, these companies have grown so powerful that their influence over human affairs equals that of many governments. Their power stems from data collected by devices that people welcome into their homes, workplaces, schools, and public spaces. When paired with artificial intelligence, these devices form a vast surveillance network that sorts people into increasingly specific categories related to health, sexuality, religion, and other categories. However, this surveillance network was not created solely to observe human behavior; it was also designed to exert control. Accordingly, it is paired with a second network that leverages intelligence gained through surveillance to manipulate people\u27s behavior, nudging them through personalized newsfeeds, targeted advertisements, dark patterns, and other forms of coercive choice architecture. Together, these dual networks of surveillance and control form a global digital panopticon, a modern analog of Bentham\u27s eighteenth-century building designed for total surveillance. Moreover, they enable a pernicious type of influence that Foucault defined as biopower: the ability to measure and modify the behavior of populations to shift social norms. This Article is the first to introduce biopower into antitrust doctrine. It contends that a handful of companies are vying for a dominant share of biopower to achieve biosupremacy, monopolistic power over human behavior. The Article analyzes how companies concentrate biopower through unregulated conglomerate and concentric mergers that add software and devices to their surveillance and control networks. Acquiring technologies in new markets establishes cross-market data flows that send information to acquiring firms across market boundaries. Conglomerate and concentric mergers also expand the control network, establishing beachheads from which platforms exert biopower to shift social norms. Antitrust regulators should expand their conception of consumer welfare to account for the costs imposed by surveillance and coercive choice architecture on product quality. They should revive conglomerate merger control, abandoned in the 1970s, and update it for the Digital Age. Specifically, regulators should halt mergers that concentrate biopower, prohibit the use of dark patterns, and mandate data silos, which contain data within specific markets, to block cross-market data flows

Psychedelic Medicine for Mental Illness and Substance Use Disorders: Overcoming Social and Legal Obstacles

Mental illness is a public health crisis. Millions of Americans suffer through their days crippled by symptoms of mood, anxiety, and substance use disorders. These conditions take large social and economic tolls on our communities. However, the medicines used to treat them have remained largely unchanged for over fifty years. Though helpful to many people, traditional psychiatric drugs are often ineffective, prompting patients and physicians to seek alternatives including psychedelic compounds such as ketamine, psilocybin, MDMA, and DMT. These drugs showed therapeutic potential in the mid-twentieth century until the U.S. War on Drugs halted all research. Now, having few alternatives, scientists are revisiting psychedelics as treatments for mental illness. This article is the first comprehensive review of the social and legal obstacles to developing psychedelic medicines. It argues that the current mental health and opioid crises demand scientific exploration of the therapeutic potential of these drugs. With subtle modifications to state and federal drug law, psychedelics could be thoroughly studied and made available to patients under carefully controlled conditions. Possible pathways include working within the existing federal regulatory framework to gain Food and Drug Administration (FDA) approval for psychedelics; removing psychedelics from the Drug Enforcement Administration (DEA) list of Schedule I controlled substances; reducing federal restrictions on psychedelics research without changing their Schedule I status; decriminalizing psychedelics at the state level; creating state-governed systems for regulating psychedelics; and implementing state-sponsored psychedelics research programs. Some approaches may be counterproductive or have counterintuitive results. Recent state level marijuana reform efforts could serve as a roadmap for amending the laws governing psychedelics. Ultimately, creative solutions that promote collaboration between state and federal government may be most likely to succeed

Artificial Intelligence-Based Suicide Prediction

Suicidal thoughts and behaviors are an international public health problem 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 artificial intelligence-based suicide prediction algorithms. This article describes these tools and the underexplored risks they pose to patients and consumers. AI-based suicide prediction is developing along two separate tracks. In medical suicide prediction, Al analyzes data from patient medical records. In social suicide prediction, Al analyzes consumer behavior derived from social media, smartphone apps, and the Internet of Things (IoT). Because medical suicide prediction occurs within the context of healthcare, it is governed by the Health Information Portability and Accountability Act (HIPAA), which protects patient privacy; the Federal Common Rule, which protects the safety of human research subjects; and general principles of medical ethics. Medical suicide prediction tools are developed methodically in compliance with these regulations, and the methods of its developers are published in peer-reviewed academic journals. In contrast, social suicide prediction typically occurs outside the healthcare system where it is almost completely unregulated. Corporations maintain their suicide prediction methods as proprietary trade secrets. Despite this lack of transparency, social suicide predictions are deployed globally to affect people\u27s lives every day. Yet little is known about their safety or effectiveness. Though AI-based suicide prediction has the potential to improve our understanding of suicide while saving lives, it raises many risks that have been underexplored. The risks include stigmatization of people with mental illness, the transfer of sensitive personal 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

Emergent Medical Data: Health Information Inferred by Artificial Intelligence

Artificial intelligence (AI) can infer health data from people’s behavior even when their behavior has no apparent connection to their health. AI can monitor one’s location to track the spread of infectious disease, scrutinize retail purchases to identify pregnant customers, and analyze social media to predict who might attempt suicide. These feats are possible because, in modern societies, people continuously interact with internet-enabled software and devices. Smartphones, wearables, and online platforms monitor people’s actions and produce digital traces, the electronic remnants of their behavior. In their raw form, digital traces might not be very interesting or useful; one’s location, retail purchases, and internet browsing habits are relatively mundane data points. However, AI can enhance the value of digital traces by transforming them into something more useful—emergent medical data (EMD). EMD is health information inferred by artificial intelligence from otherwise trivial digital traces. This Article describes how EMD-based profiling is increasingly promoted as a solution to public health crises such as the COVID-19 pandemic, gun violence, and the opioid crisis. However, there is little evidence to show that EMD-based profiling works. Even worse, it can cause significant harm, and current privacy and data protection laws contain loopholes that allow public and private entities to mine EMD without people’s knowledge or consent. After describing the risks and benefits of EMD mining and profiling, the Article proposes six different ways of conceptualizing these practices. It concludes with preliminary recommendations for effective regulation. Potential options include banning or restricting the collection of digital traces, regulating EMD mining algorithms, and restricting how EMD can be used once it is produced

Controlled Substance Regulation for the COVID-19 Mental Health Crisis

The COVID-19 pandemic is producing widespread loss of life, unemployment, and social isolation that is triggering a mental health crisis. Experts warn there could be record levels of depression, suicide, and substance use disorders. The U.S. healthcare system is not prepared. It lacks the resources to provide prolonged psychotherapy at scale, and existing drug treatments are ineffective in about half the people who ty them. Amid worsening mental health-related morbidiy and mortaliy, the experimental drugs psilocybin and 3,4- Methylenedioxymethamphetamine (MDMA) are an untapped resource. These drugs belong to a class of compounds called the psychedelics, which has been criminalized and stigmatized by the U.S. war on drugs for over fly years. The US. Drug Enforcement Administration (DEA) classifies them as Schedule I controlled substances with a high potential for abuse and no currently accepted medical uses. However, recent clinical trials conducted in the United States and abroad undermine the DEA\u27s position and suggest that psilocybin and MDMA can safely treat a variety of mental health conditions. Moreover, unlike existing therapies, they act quickly, and their benefits are often sustained. This Article explores the legal obstacles to administering psilocybin and MDMA to mitigate the COVID-19 mental health crisis. It surveys the scientfic evidence for their use and outlines a path toward rapid deployment. Due to the urgent need for effective mental health treatments, the DEA should deschedule psilocybin, reschedule MDMA, and lift annual aggregate production quotas on these drugs. The Food and Drug Administration (FDA) should issue emergency use authorizations (EUAs) for their therapeutic use. To enhance safety, the FDA Commissioner can attach conditions of use to the EUAs, comparable to Risk Evaluation and Mitigation Strategies (REMS), such as requiring psilocybin and MDMA to be administered in controlled settings under professional supervision. Prior to the onset of COVID-19, several cities decriminalized psychedelics while acknowledging their therapeutic benefits. The U.S. Department ofjustice (DOJ), which enforces violations of the federal Controlled Substances Act (CSA), should pledge not to prosecute individuals who use psychedelics in accordance with state and local laws. Meanwhile, amid growing national scrutiny of law enforcement policies and procedures following high-profile police killings, Congress should reevaluate the DOJ\u27s prominent role in U.S. drug policy. It has come to light that the war on drugs rests on afoundation of misinformation and racial animus, which has devasted communities of color. Moreover, due to restrictions on research and development, the drug war adversely impacts people with mental health conditions by depriving them of effective drug therapies. Accordingly, Congress should amend the CSA to shift drug controlfrom law enforcement agencies to science and public-health oriented agencies, such as the FDA and the National Institutes of Health. This restructuring of responsibilities would align federal controlled substance regulation with state drug control, which is overseen by public health agencies instead of law enforcement

Automating FDA Regulation

In the twentieth century, the Food and Drug Administration (“FDA”) rose to prominence as a respected scientific agency. By the middle of the century, it transformed the U.S. medical marketplace from an unregulated haven for dangerous products and false claims to a respected exemplar of public health. More recently, the FDA’s objectivity has increasingly been questioned. Critics argue the agency has become overly political and too accommodating to industry while lowering its standards for safety and efficacy. The FDA’s accelerated pathways for product testing and approval are partly to blame. They require lower-quality evidence, such as surrogate endpoints, and shift the FDA’s focus from premarket clinical trials toward postmarket surveillance, requiring less evidence up front while promising enhanced scrutiny on the back end. To further streamline product testing and approval, the FDA is adopting outputs from computer models, enhanced by artificial intelligence (“AI”), as surrogates for direct evidence of safety and efficacy. This Article analyzes how the FDA uses computer models and simulations to save resources, reduce costs, infer product safety and efficacy, and make regulatory decisions. To test medical products, the FDA assembles cohorts of virtual humans and conducts digital clinical trials. Using molecular modeling, it simulates how substances interact with cellular targets to predict adverse effects and determine how drugs should be regulated. Though legal scholars have commented on the role of AI as a medical product that is regulated by the FDA, they have largely overlooked the role of AI as a medical product regulator. Modeling and simulation could eventually reduce the exposure of volunteers to risks and help protect the public. However, these technologies lower safety and efficacy standards and may erode public trust in the FDA while undermining its transparency, accountability, objectivity, and legitimacy. Bias in computer models and simulations may prioritize efficiency and speed over other values such as maximizing safety, equity, and public health. By analyzing FDA guidance documents and industry and agency simulation standards, this Article offers recommendations for safer and more equitable automation of FDA regulation

Patents on Psychedelics: The Next Legal Battlefront of Drug Development

In the past two decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for centuries, and researchers studied them in the i9gos and \u276cs. However, most psychedelics were banned in the \u277os, when President Nixon launched the U.S. war on drugs. Fifty years later, rising rates of mental illness, substance use, and suicide are prompting researchers to revisit psychedelics, and some have gained permission to study them in limited quantities. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics. This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Patents on psychedelics raise unique concerns associated with their unusual qualities, history, and regulation. Because they were criminalized for decades, the U.S. Patent and Trademark Office (PTO) lacks personnel with expertise in the field, rendering more questionable the quality of its evaluation of psychedelic patents. Moreover, because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, the exploitation of Indigenous knowledge without compensation. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. The Essay presents proposals to reduce the risk of biopiracy and the issuance of unwarranted psychedelic patents. Potential solutions include the implementation of psychedelic patent pledges, the creation of psychedelic prior art repositories, and the tightening of patentability requirements for novel drug therapies. The Essay concludes that ultimately, due to their importance to the advancement of science and public health, it may be appropriate to view psychedelics as tools of scientific discovery, eligible only for limited patent protection

Incentivizing preventive services in primary care: perspectives on Local Enhanced Services

Background: General practitioners in the UK play a key role in prevention but provision of preventive services is variable. The 2004 General Medical Services contract allows Primary Care Trusts (PCTs) to address health needs through providing locally agreed payments for Local Enhanced Services (LESs). This study identifies how this contractual flexibility is used for preventive services and explores its perceived effectiveness. Methods: Semi-structured interviews were carried out (2008–09) in 10 purposively selected case study sites in England. Details of LESs for these sites were collected (2009) through Freedom of Information requests or local contacts. A national on-line survey of PCTs (2009) provided a national context for case study findings. Results: LESs were considered to be effective in incentivizing preventive activity. However, specifications and performance management were often weak, awareness of how to optimize incentives was low and, as optional services, LESs were perceived to be at risk in a financial downturn. Conclusions: Using LESs for preventive services highlights gaps in ‘core’ primary care responsibilities and in the national pay-for-performance framework. Current incentive arrangements are complex, could increase inequalities and provide only a partial, short-term solution to developing a proactive approach to prevention in primary care