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Cedar Ridge, CA, United States

California Western School of Law, founded in 1924, is a private, non-profit law school located in San Diego, California. It is popularly known as California Western or Cal Western and formerly California Western University. The school was approved by the American Bar Association in 1962 and became a member of the Association of American Law Schools in 1967. It is the oldest law school in San Diego. Wikipedia.

Mackey T.K.,California Western School of Law | Mackey T.K.,University of California at San Diego | Liang B.A.,University of California at San Diego
Globalization and Health

Background: Digital forms of direct-to-consumer pharmaceutical marketing (eDTCA) have globalized in an era of free and open information exchange. Yet, the unregulated expansion of eDTCA has resulted in unaddressed global public health threats. Specifically, illicit online pharmacies are engaged in the sale of purportedly safe, legitimate product that may in fact be counterfeit or substandard. These cybercriminal actors exploit available eDTCA mediums over the Internet to market their suspect products globally. Despite these risks, a detailed assessment of the public health, patient safety, and cybersecurity threats and governance mechanisms to address them has not been conducted.Discussion: Illicit online pharmacies represent a significant global public health and patient safety risk. Existing governance mechanisms are insufficient and include lack of adequate adoption in national regulation, ineffective voluntary governance mechanisms, and uneven global law enforcement efforts that have allowed proliferation of these cybercriminals on the web. In order to effectively address this multistakeholder threat, inclusive global governance strategies that engage the information technology, law enforcement and public health sectors should be established.Summary: Effective global "eHealth Governance" focused on cybercrime is needed in order to effectively combat illicit online pharmacies. This includes building upon existing Internet governance structures and coordinating partnership between the UN Office of Drugs and Crime that leads the global fight against transnational organized crime and the Internet Governance Forum that is shaping the future of Internet governance. Through a UNODC-IGF governance mechanism, investigation, detection and coordination of activities against illicit online pharmacies and their misuse of eDTCA can commence. © 2013 Mackey and Liang; licensee BioMed Central Ltd. Source

Mackey T.K.,San Diego State University | Liang B.A.,California Western School of Law
Journal of Public Health Policy

No formal system exists to review trade restrictions imposed during international public health emergencies rapidly. Failure to put one in place creates disincentives for surveillance and reporting, thereby undermining protection efforts. The 2003 SARS outbreak exposed weaknesses in global governance that caused uncoordinated public health and economic responses. New International Health Regulations (IHR), applied first during the 2009 H1N1 influenza outbreak, demonstrated improvement. Yet they failed to allow for management of public health emergencies in a way that balanced threats to health and those to economies and trade. Establishment of a joint WHO-WTO committee to adjudicate these conflicts might better achieve that balance. © 2012 Macmillan Publishers Ltd. Source

Liang B.A.,California Western School of Law
Journal of medical Internet research

Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. Source

Lovett K.M.,California Western School of Law | Lovett K.M.,University of California at San Diego | Liang B.A.,University of California at San Diego
Nature Reviews Cancer

Direct-to-consumer online advertising for thermography as a sole agent with which to diagnose breast cancer is misleading and exploits women who are seeking preventive health care for breast cancer. Regulatory action should be taken against companies who continue to mislead the public to ensure patient safety and evidence-based public health information. © 2011 Macmillan Publishers Limited. All rights reserved. Source

Cuomo R.,University of California at San Diego | Guerra C.,San Diego State University | Liang B.A.,California Western School of Law
Nature Reviews Clinical Oncology

Three years have passed since the FDA announced that it had detected counterfeit versions of the injectable anticancer drug bevacizumab (Avastin ®, Genentech, USA) in the US drug-supply chain. Following this discovery, almost 1,000 FDA warning letters were sent to physicians and medical practices in 48 different states and two US territories, as more batches of counterfeit Avastin were uncovered. In response, criminal prosecutions have been pursued against certain distributors and clinicians, and other individuals who trafficked, sold, purchased, and/or administered an unsafe and ineffective treatment while also defrauding the government. Although limited and targeted legal action has been taken, patients potentially affected by this seminal patient safety event have not been appropriately identified. Hence, despite the clear and documented patient-safety and public-health risks posed by the transnational criminal trade in counterfeit medicines, the case study of counterfeit bevacizumab detection in the USA demonstrates the continued lack of information, knowledge, and solutions that would be necessary to protect those who are most affected - the patients. In response, we call for greater investment in multisector, multistakeholder strategies to enhance surveillance for counterfeit medicines and enable improvements in communication of risk information, to better protect patients with cancer. © 2015 Macmillan Publishers Limited. Source

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