BACKGROUND: The efficacy of perineal self-acupressure in treating constipation is uncertain. OBJECTIVE: We aimed to evaluate whether perineal self-acupressure would improve patient reports of quality of life and bowel function at 4 weeks after training. DESIGN: A randomized, parallel group trial was conducted. SETTING: The study took place at the UCLA Department of Medicine. PATIENTS: One hundred adult patients who met Rome III criteria for functional constipation participated. INTERVENTION: The control group received information about standard constipation treatment options, while the treatment group received training in perineal self-acupressure plus standard treatment options. MEASUREMENTS: Primary outcome was the Patient Assessment of Constipation Quality of Life (PAC-QOL). Secondary outcomes included patient assessments of bowel function (as measured by a modified Bowel Function Index (BFI)), and health and well-being (as measured by the SF-12v2). RESULTS: The mean PAC-QOL was improved by 0.76 in the treatment group and by 0.17 in the control group (treatment-effect difference, 0.59 [95 % CI, 0.37 to 0.81]; p
Abbott RB, Hui KK, Hays RD, Li MD, Pan T (2007) A randomized controlled trial of Tai Chi for tension headaches, Evidence-based Complementary and Alternative Medicine 4 (1) pp. 107-113 Hindawi Publishing Corporation
This study examined whether a traditional low-impact mind-body exercise, Tai Chi, affects health-related quality-of-life (HRQOL) and headache impact in an adult population suffering from tension-type headaches. Forty-seven participants were randomly assigned to either a 15 week intervention program of Tai Chi instruction or a wait-list control group. HRQOL (SF-36v2) and headache status (HIT-6") were obtained at baseline and at 5, 10 and 15 weeks post-baseline during the intervention period. Statistically significant (P
Abbott R, Lavretsky H (2013) Tai Chi and Qigong for the Treatment and Prevention of Mental Disorders, Psychiatric Clinics of North America 36 (1) pp. 109-119
Tai Chi and Qigong are traditional Chinese exercises that are widely practiced for their health benefits and as martial arts. Evidence suggests that these practices may be effective at treating a range of physical health conditions, and at improving health-related quality of life. There is growing interest in the use of Tai Chi and Qigong to treat mental disorders, because they are noninvasive, exercise-based therapies, and because patients with mental disorders frequently use complementary and alternative medicine. Evidence is promising that these treatments may be effective in reducing depressive symptoms, stress, anxiety, and mood disturbances. © 2013 Elsevier Inc. All rights reserved.
Abbott R (2014) Post-Market Drug Regulation in the Age of Big Data: What Path to the Promised Land?, FDLI's Food and Drug Policy Forum 4 (10) pp. 1-14 Food and Drug Law Insititute
This article argues that an administrative bounty proceeding should be established to motivate third parties to submit data on drug safety and efficacy to the food and drug agency. The administrative bounty proceeding should be modeled after the Federal Claims Act qui tam regime, and the federal government should pay petitioner rewards based on a portion of the money that the government will save by avoiding adverse effects and medically ineffective therapies in patients with government health insurance.
Abbott R (2012) Overcoming Barriers to a Global Treaty on Medical Funding and R&D, Journal of the Brazilian Institute for Intellectual Property 7 pp. 70-76
Abbott R, Zhang W (2007) Meeting Report for the UCLA Center for East-West Medicine 2006 Annual Conference: Integration of Traditional Chinese Medicine and Western Medicine - Research and Clinical Applications, Chinese Journal of Integrative Medicine 13 (1) pp. 74-75
Abbott R (2014) Documenting Traditional Medical Knowledge, World Intellectual Property Organization World Intellectual Property Organization
Traditional medical knowledge is experiencing increased attention worldwide in light of global health care demand and the significant role of traditional medicine in meeting the public health needs of developing countries. Traditional medicines already comprise a multi-billion dollar, international industry, and the biomedical sector is increasingly investigating the potential of genetic resources and traditional knowledge. Documenting and protecting these medicines is becoming a greater priority.
Traditional knowledge has historically been at odds with modern intellectual property systems designed to protect innovations such as new pharmaceutical drugs. However, as the financial value of many forms of traditional medicine becomes recognized, traditional knowledge holders and nations rich in genetic resources are arguing for greater protection through non-conventional systems of intellectual property protection. Traditional knowledge holders are increasingly demanding fair and equitable distribution of benefits from the commercialization of traditional medicine, as well as the prior informed consent of indigenous peoples to prevent misappropriation.
Many problems associated with the protection of traditional medical knowledge lack clear solutions. In attempting to protect traditional medicine, traditional knowledge holders are confronted by a confusing and diverse group of national and international policies, regulatory systems designed primarily to accommodate pharmaceutical medicines, safety and efficacy concerns, and challenges to ownership.
This text is designed to assist traditional medical knowledge holders, government representatives and third-party collaborators to think about issues of intellectual property law specifically related to traditional medical knowledge. It is not intended to provide legal advice, but rather to help stimulate thinking about traditional knowledge and to provide illustrative case studies.
There is no generic way to protect traditional medical knowledge. Traditional knowledge holders should carefully consider identified community goals for the use of traditional medicine and the risks and benefits of documentation. Whether traditional medical knowledge is documented can have far reaching consequences on intellectual property protection, commercialization and promotion of traditional medicine, regulatory submissions and interactions with collaborators. It is important that traditional knowledge holders be adequately
Abbott R, Lavretsky H (2013) Tai Chi and Qi Gong for Treatment and Prevention of Mental Disorders, Psychiatr Clin North Am 36 (1) pp. 109-119 Elsevier
Tai Chi and Qigong are traditional Chinese exercises that are widely practiced for their health benefits and as martial arts. Evidence suggests that these practices may be effective at treating a range of physical health conditions, and at improving health-related quality of life. There is growing interest in the use of Tai Chi and Qigong to treat mental disorders, because they are noninvasive, exercise-based therapies, and because patients with mental disorders frequently use complementary and alternative medicine. Evidence is promising that these treatments may be effective in reducing depressive symptoms, stress, anxiety, and mood disturbances.
Abbott R (2013) Big data and pharmacovigilance: Using health information exchanges to revolutionize drug safety, Iowa Law Review 99 (1) pp. 225-292 Iowa Law Review
Data on individual patients collected through state and federal health information exchanges has the potential to usher in a new era of drug regulation. These exchanges, produced by recent health care reform legislation, will amass an unprecedented amount of clinical information on drug usage, demographic variables, and patient outcomes. This information could aid the Food and Drug Administration ("FDA") with post-market drug surveillance because it more accurately reflects clinical practice outcomes than the trials the FDA relies upon for drug approval. However, even with this data available, the market-driven impetus to use it to police drugs is weak. This is fixable; the post-market drug regulatory process needs new incentives to boost third party participation. While a variety of mechanisms could achieve this, the best option for generating robust results may be an administrative bounty proceeding that will allow third parties to submit evidence to the FDA to contest the claimed safety and efficacy profiles of drugs already on the market. This Article uses a case study of Merck's former blockbuster drug Vioxx to demonstrate how this system might work. In creating a new incentive that counters the powerful financial motivation of drug manufacturers to obscure or misrepresent safety profiles, the proposed bounty proceeding could lead to an improved balance of the risks and benefits of drugs used by the American public. More broadly, this Article illustrates how to create an incentive for the private sector to supplement regulatory activity in a complex field.
Abbott R, Cohen M (2013) Medico-legal issues in cardiology, Cardiology in Review 21 (5) pp. 222-228 Lippincott, Williams & Wilkins
The aim of this article is to educate physicians about the current litigation climate in cardiology and cardiac surgery, with a focus on the most frequently litigated areas of practice, including failure to diagnose and treat myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, and the use of tissue plasminogen activator. Empirical research on cardiology malpractice is presented, along with a sampling of up-to-date cases designed to illustrate common issues and important themes. The principles for reducing legal liability are also discussed, including the informed consent process, spoliation of records, and the role of documentation. Finally, practical recommendations are provided for cardiologists and cardiac surgeons to limit their legal liability. © 2013 Lippincott Williams & Wilkins.
Alabbadi I, Abbott R, Jaber D (2014) Jordanian stakeholder attitudes toward generic substitution, Journal of Generic Medicines 11 (1-2) pp. 24-34 SAGE Publications Ltd
About 10% of Jordan's gross domestic product is spent on health care, almost one-third of which is spent on pharmaceuticals. Jordan's pharmaceutical spending is a substantially higher percentage of gross domestic product than that of other developed countries. Generic substitution is a mechanism that could lower pharmaceutical spending costs in Jordan, but Jordan's domestic law currently forbids pharmacists in the private market from dispensing generic equivalents to branded medicines without a physician's approval. This article provides the results of a study that surveyed prominent organizational stakeholders (n=17, RR 100%) in Jordan's health care system and evaluates their opinions about generic substitution. The study finds there is abroad base of support for allowing and encouraging generic substitution in the private sector, and for mandating generic substitution in the public sector. Given that generic substitution may help to reduce health care costs and improve access to medicines, policymakers should consider legal and policy changes to facilitate generic substitution. The research suggests that key players in Jordan's health care system will support such proposals. © The Author(s) 2014.
Abbott R (2014) Balancing Access and Innovation in India's Shifting IP Regime, Remarks, Whittier Law Review 35 pp. 341-341
Abbott R, Hui KK (2015) Perineal Self-Acupressure?s Mechanism of Action, Journal of General Internal Medicine 30 (4) pp. 399-399 Springer New York LLC
Abbott R (2009) The Beijing Declaration: A Landmark for Traditional Medicine, ICTSD-Bridges 13 (1) International Centre for Trade and Sustainable Development
Last November in Beijing, government officials representing member states of the World Health Organisation adopted a declaration that provides a powerful endorsement of traditional medicine and may one day become the foundation for a legally binding resolution.
Epstein R, Abbott R (2014) Involvement in Off-Label Use: Debate Between Richard Epstein and Ryan Abbott, Southwestern Law Review 44 (1) Southwestern Law School
Abbott R (2015) FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, Journal of Law and the Biosciences 3 (1) pp. 248-252 Oxford University Press
Abbott R (2012) Treating the Health Care Crisis: Complementary and Alternative Medicine for PPACA, DePaul Journal of Health Care Law 14 (1) pp. 35-98 DePaul College of Law
The Patient Protection and Affordable Care Act (PPACA) intends to take American health care in a new direction by focusing on preventive medicine and wellness-based treatment. But, in doing so, it does not adequately take into account the potential contribution of complementary and alternative medicine (CAM). CAM is already used by a large and growing number of individuals in the United States, although to date there is limited scientific evidence to support the efficacy of most CAM treatments. This article proposes statutory reforms to PPACA to encourage CAM research and development (R&D), and the use of demonstrably effective CAM treatments. A hybrid system of limited intellectual property protection and government prizes based on regulatory approval may be the best option for incentivizing R&D on CAM, along with increased funding for research through the National Institutes of Health. PPACA should require health insurance plans to reimburse for evidence-based CAM and empower an existing government agency (NCCAM) to regulate CAM standards and to recommend evidence-based CAM services. Together these policy and funding mechanisms should help reduce U.S. healthcare costs and improve quality of life.
Abbott R (2016) The Sentinel Initiative as a Cultural Commons, In: Strandburg K (eds.), Governing Medical Research Commons Cambridge University Press
Abbott RB, Bader R, Bajjali L, Elsamen TA, Obeidat T, Sboul H, Shwayat M, Alabbadi I (2012) The price of medicines in Jordan: The cost of trade-based intellectual property, Journal of Generic Medicines 9 (2) pp. 75-85 Sage
Jordan dramatically strengthened the level of intellectual property protection it provides for pharmaceutical products in consequence of joining the World Trade Organization in 2000 and signing a Free Trade Agreement with the United States in 2001. This study assesses the impact of higher levels of intellectual property protection on access to medicines by quantifying the effects on the private retail pharmaceutical market of delayed market entry of generic products. Adjusted for increased sales volume and inflation, from 1999 to 2004 there was a 17% increase in total annual expenditure for medicines in Jordan. When assessing originator medicines that were marketed in both 1999 and 2004, and for which there were generic equivalents, the weighted average price of originator medicines increased while the weighted average price of equivalent generic medicines decreased. Delayed market entry of generics due to enhanced intellectual property protection is estimated to have cost Jordanian private consumers approximately 18 million U.S. dollars in 2004. Jordan should consider amending its current regulatory scheme on data protection and amending the Unfair Competition and Trade Secrets Law of 2000. Jordan should also consider increased spending on public health to offset the adverse impact on consumers of strengthening its intellectual property protection relevant to pharmaceutical products. © 2012 The Author(s).
Cohen MH, Natbony SR, Abbott RB (2013) Complementary and alternative medicine in child and adolescent psychiatry: Legal considerations, Child and Adolescent Psychiatric Clinics of North America 22 (3) pp. 493-507 Elsevier
The rising popularity of complementary and alternative medicine (CAM) in child and adolescent psychiatry raises unique ethical and legal concerns for psychiatrists and other conventional health care providers. This article explores these concerns and provides clinical advice for promoting patient health and safety while minimizing the psychiatrist's risk. Although any departure from the conventional standard of care is a potential risk, the risk of malpractice liability for practicing integrative medicine in child and adolescent psychiatry is low. CAM is most safely recommended from a legal standpoint when there is some published evidence of safety and efficacy. © 2013 Elsevier Inc.
Artificial intelligence is part of our daily lives. Whether working as taxi drivers, financial analysts, or airport security, computers are taking over a growing number of tasks once performed by people. As this occurs, computers will also cause the injuries inevitably associated with these activities. Accidents happen, and now computer-generated accidents happen. The recent fatality caused by Tesla?s autonomous driving software is just one example in a long series of ?computer-generated torts.?
Yet hysteria over such injuries is misplaced. In fact, machines are, or at least have the potential to be, substantially safer than people. Self-driving cars will cause accidents, but they will cause fewer accidents than human drivers. Because automation will result in substantial safety benefits, tort law should encourage its adoption as a means of accident prevention.
Under current legal frameworks, manufacturers (and retailers) of computer tortfeasors are likely strictly responsible for their harms. This article argues that where a manufacturer can show that an autonomous computer, robot, or machine is safer than a reasonable person, the manufacturer should be liable in negligence rather than strict liability. The negligence test would focus on the computer?s act instead of its design, and in a sense, it would treat a computer tortfeasor as a person rather than a product. Negligence-based liability would create a powerful incentive to automate when doing so would reduce accidents, and it would continue to reward manufactures for improving safety.
In fact, principles of harm avoidance suggest that once computers become safer than people, human tortfeasors should no longer be judged against the standard of the hypothetical reasonable person that has been employed for hundreds of years. Rather, individuals should be measured against computers. To appropriate the immortal words of Justice Holmes, we are all ?hasty and awkward? compared to the reasonable computer.
Existing technologies can already automate most work functions, and the cost of these technologies is decreasing at a time when human labor costs are increasing. This, combined with ongoing advances in computing, artificial intelligence, and robotics, has led experts to predict that automation will lead to significant job losses and worsening income inequality. Policy makers are actively debating how to deal with these problems, with most proposals focusing on investing in education to train workers in new job types, or investing in social benefits to distribute the gains of automation.
The importance of tax policy has been neglected in this debate, which is unfortunate because such policies are critically important. The tax system incentivizes automation even in cases where it is not otherwise efficient. That is because the vast majority of tax revenue is now derived from labor income, so firms avoid taxes by eliminating employees. More importantly, when a machine replaces a person, the government loses a substantial amount of tax revenue?potentially trillions of dollars a year in the aggregate. All of this is the unintended result of a system designed to tax labor rather than capital. Such a system no longer works once the labor is capital. Robots are not good taxpayers.
We argue that existing tax policies must be changed. The system should be at least ?neutral? as between robot and human workers, and automation should not be allowed to reduce tax revenue. This could be achieved by disallowing corporate tax deductions for automated workers, creating an ?automation tax? which mirrors existing unemployment schemes, granting offsetting tax preferences for human workers, levying a corporate self-employment tax, or increasing the corporate tax rate. We argue the ideal solution may be a combination of these proposals.
Clinicians still employ a ?trial-and-error? approach to optimizing treatment regimens for late-life depression (LLD). With LLD affecting a significant and growing segment of the population, and with only about half of older adults responsive to antidepressant therapy, there is an urgent need for a better treatment paradigm. Pharmacogenetic decision support tools (DSTs), which are emerging technologies that aim to provide clinically actionable information based on a patient?s genetic profile, offer a promising solution. Dozens of DSTs have entered the market in the past fifteen years, but with varying level of empirical evidence to support their value. In this clinical review, we provide a critical analysis of the peer-reviewed literature on DSTs for major depression management. We then discuss clinical considerations for the use of these tools in treating LLD, including issues related to test interpretation, timing, and patient perspectives. There are no primary clinical trials in LLD cohorts. However, in adult populations, newer generation DSTs show promise for the treatment of major depression. Further independent and head-to-head clinical trials are required to further validate this field.
In some cases, a computer?s output constitutes patentable
subject matter, and the computer rather than a person
meets the requirements for inventorship. As such machines
become an increasingly common part of the inventive process,
they may replace the standard of the person skilled in
the art now used to judge nonobviousness. Creative computers
require a rethinking of the criteria for inventiveness,
and potentially of the entire patent system.
Artificial intelligence has been generating inventive output for decades, and now the continued and exponential growth in computing power is poised to take creative machines from novelties to major drivers of economic growth. In some cases, a computer?s output constitutes patentable subject matter, and the computer rather than a person meets the requirements for inventorship. Despite this, and despite the fact that the Patent Office has already granted patents for inventions by computers, the issue of computer inventorship has never been explicitly considered by the courts, Congress, or the Patent Office. Drawing on dynamic principles of statutory interpretation and taking analogies from the copyright context, this Article argues that creative computers should be considered inventors under the Patent and Copyright Clause of the Constitution. Treating nonhumans as inventors would incentivize the creation of intellectual property by encouraging the development of creative computers. This Article also addresses a host of challenges that would result from computer inventorship, including the ownership of computer-based inventions, the displacement of human inventors, and the need for consumer protection policies. This analysis applies broadly to nonhuman creators of intellectual property, and explains why the Copyright Office came to the wrong conclusion with its Human Authorship Requirement. Finally, this Article addresses how computer inventorship provides insight into other areas of patent law. For instance, computers could replace the hypothetical skilled person that courts use to judge inventiveness. Creative computers may require a rethinking of the baseline standard for inventiveness, and potentially of the entire patent system.
An innovation revolution is on the horizon. Artificial intelligence (AI) has been generating inventive output for decades, and now the continued and exponential growth in computing power is poised to take creative machines from novelties to major drivers of economic growth. A creative singularity in which computers overtake human inventors as the primary source of new discoveries is foreseeable.
Physicians have long worried about gene patents? potential to restrict their medical practices.
Fortune and hindsight have proven these worries exaggerated both in the U.K. and elsewhere. Neither
current nor future medical practices appear to be impinged by gene patents, although they may be
subject to future intellectual property disputes.
Sources of Data:
Qualitative and quantitative (survey) studies of gene patents? effects on medical practice; recent
developments in patent law.
Areas of Agreement:
Traditional gene patents do not appear to have restricted medical practice in the U.K., although
their effect elsewhere has been more nuanced.
Areas of Controversy:
Whether patents will restrict the spread of newer medical technologies is unresolved.
Areas Timely for Developing Research:
Continuing survey data on practitioners? views concerning patents? role in the distribution of
newer technologies would be beneficial.
For more than 60 years, ?obviousness? has set the bar for patentability. Under this standard, if a hypothetical person skilled in the art would find an invention obvious in light of existing relevant information, then the invention cannot be patented. The skilled person is defined as a non-innovative worker with a limited knowledge-base. The more creative and informed the skilled person, the more likely an invention will be considered obvious. The standard has evolved since its introduction, and it is now on the verge of an evolutionary leap. Inventive machines are increasingly being used in research, and once the use of such machines becomes standard, the person skilled in the art should be a person using an inventive machine, or just an inventive machine. Unlike the skilled person, the inventive machine is capable of innovation and considering the entire universe of prior art. As inventive machines continue to improve, this will increasingly raise the bar to patentability, eventually rendering innovative activities obvious. The end of obviousness means the end of patents, at least as they are now.
Life science company decision-makers can effectively manage disputes using appropriate dispute resolution techniques without resorting to expensive, complex, and uncertain litigation.