Search

Stem cell tourism is a small but growing part of the thriving global medical tourism marketplace. Much stem cell research remains at the experimental stage, with clinical trials still uncommon. However, there are over 700 clinics estimated to be operating in mostly developing countries--from Costa Rica and Argentina to China, India and Russia--that have lured many patients, mostly from industrialized countries, driven by desperation and hope, which in turn continue to fuel the growth of such tourism. While much research has focused on such dimensions as the promotions that allow such businesses to make their services known, media coverage, some patient research, and regulatory conditions for developing country clinics, little attention has been paid to the non-affected members of the general population, the future potential users of such services. This empirical study based on five focus group discussions with a diverse group of healthy adults in a Canadian city, explored participant views of patients who use stem cell tourism services, the likelihood they would avail themselves of such services if they were to suffer similar illnesses, and the conditions under which they might do so, and the impact that admonitions and advice from international expert bodies might have on their decisions. Our findings suggest that these healthy adults are sympathetic to the drivers of hope and desperation, and, despite cautions about research limitations, may seek such treatments themselves under similar conditions. These findings are discussed in the context of the policy and ethical issues raised by this form of medical tourism., (© 2012 Blackwell Publishing Ltd.)

Nowadays, almost all persons with diabetes--at least those using antidiabetic drug therapy--use one of a plethora of meters commercially available for self-monitoring of blood glucose. The accuracy of blood glucose (BG) measurement using these meters has been presumed to be adequate; that is, the accuracy of these devices was not usually questioned until recently. Health authorities in the United States (Food and Drug Administration) and in other countries are currently endeavoring to tighten the requirements for the accuracy of these meters above the level that is currently stated in the standard ISO 15197. At first glance, this does not appear to be a problem and is hardly worth further consideration, but a closer look reveals a considerable range of critical aspects that will be discussed in this commentary. In summary, one could say that as a result of modern production methods and ongoing technical advances, the demands placed on the quality of measurement results obtained with BG meters can be increased to a certain degree. One should also take into consideration that the system accuracy (which covers many more aspects as the analytical accuracy) required to make correct therapeutical decisions certainly varies for different types of therapy. At the end, in addition to analytical accuracy, thorough and systematic training of patients and regular refresher training is important to minimize errors. Only under such circumstances will patients make appropriate therapeutic interventions to optimize and maintain metabolic control., (© 2012 Diabetes Technology Society.)

This report presents information on the state of the U.S. health system in late 2011. The authors include data on the uninsured and the underinsured and their access to health care, socioeconomic inequality in care, the rising costs of the U.S. health system, and the role of corporate money in health care, with special reference to the pharmaceutical industry and the hospice industry. They also provide updates on Medicaid and Medicare and on the new federal health care law. Some information on health care systems elsewhere in the world is also included.

This article presents the findings of a collaborative effort between the Georgetown University Student Consulting Team and Booz Allen Hamilton to interview healthcare providers undergoing the transition to the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS). The goals of this study were to extract a common set of trends, challenges, and lessons learned surrounding the implementation of the ICD-10-CM/PCS code set and to produce actionable information that might serve as a resource for organizations navigating the transition to ICD-10-CM/PCS. The selected survey sample focused on a subset of large hospitals, integrated health systems, and other national industry leaders who are likely to have initiated the implementation process far in advance of the October 2013 deadline. Guided by a uniform survey tool, the team conducted a series of one-on-one provider interviews with department heads, senior staff members, and project managers leading ICD-10-CM/PCS conversion efforts from six diverse health systems. As expected, the integrated health systems surveyed seem to be on or ahead of schedule for the ICD-10-CM/PCS coding transition. However, results show that as of April 2010 most providers were still in the planning stages of implementation and were working to raise awareness within their organizations. Although individual levels of preparation varied widely among respondents, the study identified several trends, challenges, and lessons learned that will enable healthcare providers to assess their own status with respect to the industry and will provide useful insight into best practices for the ICD-10-CM/PCS transition.

The medical device and pharmaceutical industry is facing mounting pressure to produce cost-effectiveness and clinical-effectiveness data in order for their products to be acceptable for approval by the Federal Drug Administration and then for payer reimbursement. The implications of these increasing burdens on our field will become apparent in everyday practice. This article outlines these challenges and discusses possible ways to improve the situation., (Copyright © 2012 Elsevier Inc. All rights reserved.)

The role of trust has been argued to play an increasingly important role in modern, complex, and ambivalent risk societies. Trust within organizational research is anticipated to have a general strategic impact on aspects such as organizational performance, communication and knowledge exchange, and learning from accidents. Trust is also an important aspect related to regulation of risk. Diverse regulatory regimes, their contexts and risks influence regulators use of trust and distrust in regulatory practice. The aim of this paper is to discuss the relationship between risk regulation and trust across diverse risk regulation regimes. By drawing from studies of risk regulation, risk perception, and trust the purpose is to discuss how regulation and trust are linked and used in practice to control risk across system levels in socio-technical systems in high risk industries. This paper provides new knowledge on 1) how functional and dysfunctional trust and distrust are grounded in the empirical realities of high risk industries, 2) how different perspectives on trust and distrust act together and bring new knowledge on how society control risk.

The genetic testing of minors within the direct-to-consumer (DTC) genetic testing (GT) context has been given relatively little attention. The issue of testing healthy children for diseases that would only develop in adulthood raises many important ethical, legal and social issues. As genetic testing is now available outside of the traditional health care system, often without even the intermediate of a health care professional, we surveyed 37 DTC GT companies regarding their policies for testing in children. Although the response rate is relatively low (35%, 13/37), our findings reveal that a clear majority of companies do perform genetic testing in minors. As such, companies testing for adult onset diseases are acting in contradiction of established professional guidelines, which state, among others, that, for predictive genetic testing, the availability of therapeutic or preventive measures is necessary for testing to be performed in asymptomatic minors. The community of stakeholders in children's health care and genetic testing should, therefore, decide which standards need to be upheld by DTC GT companies and ensure that these are met.

This final rule amends a May 23, 2011, final rule entitled "Rate Increase Disclosure and Review". The final rule provided that, for purposes of rate review only, definitions of "individual market" and "small group market" under State rate filing laws would govern even if those definitions departed from the definitions that otherwise apply under title XXVII of the Public Health Service Act (PHS Act). The preamble to the final rule requested comments on whether this policy should apply in cases in which State rate filing law definitions of "individual market" and "small group market" exclude association insurance policies that would be included in these definitions for other purposes under the PHS Act. In response to comments, this final rule amends the definitions of "individual market" and "small group market" that apply for rate review purposes to include coverage sold to individuals and small groups through associations even if the State does not include such coverage in its definitions of individual and small group market. This final rule also updates standards for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act.

Objectives: Advances in vascular surgery are increasingly technology-driven, and the relationships between surgeons and the medical device industry can be complex. This study reviewed conflict of interest (COI) disclosure in the vascular surgery journals regarding several selected technology-driven topics, including endovascular stent grafts (EV), carotid artery stenting (CAS), and peripheral arterial interventions (PI), to suggest further directions., Methods: Authors' COI disclosures were reviewed from all clinical papers published in 2008 and 2009 in each of six vascular surgery journals, and pertaining to three selected topics (EV, CAS, and PI). Rate of COI disclosure was evaluated as a function of journal, topic, article type (randomized trial, case series, case report, review, or meta-analysis), and authors' region of origin. Secondarily, consistency of authors' disclosure was evaluated by reviewing papers by the same author and of the same topic., Results: Six hundred thirty-five papers were reviewed from the six journals. A COI was declared in 125 (19.7%) of these papers. This rate differed between journals (range, 3.2%-34.1%; P < .0001). Rate of disclosure did not differ between topics (range, 12.8%-21.2%; P = .12), article type (range, 14.7%-30%; P = .28), or region of origin (range, 0%-33.3%; P = .09). There were 116 instances of the same author writing papers describing the same general topic. COI disclosure was consistent in the majority of these instances (72.4%), but inconsistent in 32 cases (27.6%). The most common (P = .006) inconsistencies involved the same type of article in different journals (46.9%), or in the same journal (25%)., Conclusions: Rates of disclosure of COI, and inconsistencies in disclosure in the vascular surgery literature are at least partially due to differences in journals' reporting policies, while a smaller proportion of these inconsistencies are due to individual author behavior. Journals should adopt a consistent requirement for a separate COI declaration where all relevant financial arrangements are disclosed., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Conflicts of interest in medicine have received significant attention in recent years, through the public and professional media, federal and state governments, and through a 2009 report of the Institute of Medicine on Conflict of Interest in Medical Research, Education and Practice. The Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies was adopted by the CMSS in April 2010. The Code guides specialty societies in the profession of medicine in ethical relationships between societies and the pharmaceutical and medical device industries. The Code serves to protect and promote the independence of specialty societies and their leaders in corporate sponsorships, licensing, advertising, society meetings, exhibits, educational programs, journals, clinical practice guidelines, and research., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Long subject to legal scrutiny under the federal Anti-Kickback Statute, financial ties between physicians and drug manufacturers have recently come under additional pressure as a result of recently enacted state and federal disclosure laws and state gift restrictions, the latest coming in connection with the Federal Health Reform Law. These "sunshine" laws have been motivated by the concern that gifts and payments by manufacturers to physicians may lead to conflicts of interest and improperly influence physicians in their drug- or device-prescribing decisions. As a backdrop to these new laws, it is helpful to review prior guidance regarding manufacturer-physician financial relationships, both from the federal government and the industry itself. These laws do not prohibit physician involvement with industry in research and education, but they impose various new compliance requirements on these relationships, and also in many cases, require public disclosure of arrangements that previously were treated as confidential. It is still too early to tell if these laws will stifle innovation, but they do require a heightened degree of diligence to avoid, at a minimum, adverse publicity and embarrassment and, at worst, criminal and civil liability., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Physician-industry collaboration has led to a diverse array of therapeutic advancements that have benefitted a broad spectrum of patient populations. Evolving regulations, both institutional and governmental, aiming to govern interactions between physicians and pharmaceutical and medical device manufacturers have become increasingly prevalent. Emerging data suggest that restrictions on physician-industry collaboration have the potential to harm patient care by degrading innovation and stifling medical education. The following article reviews the effects of legislation on medical innovation as well as the impact on continuing medical education., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

The interaction between pharmaceutical and device companies and hospitals and physicians has undergone significant transformation in the past few years due to the public's perception that bias may result when such relationships are not disclosed and monitored. Policies need to be written by medical centers and hospitals to preserve and retain the trust of the public. The policy written by Johns Hopkins Medical Institutions is outlined and its implications discussed in this article. The importance of such policies in guiding young faculty and staff as they begin their careers cannot be overemphasized., (Copyright © 2011. Published by Mosby, Inc.)

This article assesses the current mandates on conflict of interest issues as they affect the practice of community-based vascular surgery and the pharmaceutical and medical technology industries and expresses the views of a private practice vascular surgeon. Scenarios where conflict of interest may occur are presented with assessments on how these scenarios will play out if such mandates are enforced., (Copyright © 2011. Published by Mosby, Inc.)

Conflicts of interest exist when an arrangement potentially exerts inappropriate influence on decision making or professional judgment, or is perceived to do so, and can thus damage the public trust and undermine the integrity of those decisions. Concerns regarding financial conflicts of interest in the medical arena have reached their height as of late, given that physicians now function in a milieu of complex and delicate relationships with pharmaceutical, biotechnology, and medical device industries. Even when such relationships do not correlate with actual compromise of judgment or patient care, it threatens the credibility of both the health care professional and the institution because of the social perception of the effect of these relationships. Although most institutions in the Western world set forth a code of ethics and conflict-of-interest policies to be followed under threat of termination, the Veterans Health Administration (VHA) presents itself as a unique environment in which conflicts of interest are subject to governmental laws, violation of which may not only result in employment-related discipline, but may be sanctioned by civil and criminal penalties. Moreover, these provisions are developed by a national authoritative organization rather than being institution-specific guidelines. Given that many academic physicians working within the VHA may also have a component of their practice in a University setting, it becomes important to understand the differences in policy between these contexts so as not to threaten the public trust in the veracity of decisions made and, therefore, maintain the integrity of the relationship between physician and patient. This article will review aspects of conflict-of-interest policies in the realm of research, financial relationships, foreign travel, and vendor contracting that are particular to the VHA and make it a unique environment to function in as a physician and scientist., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Much has been made over the last few years about conflicts of interest in the health care community's relationships with industry members, including individual physicians, academic medical centers, and professional organizations. Not only has the Department of Justice (DOJ) been investigating questionable relationships, but House and Senate Oversight Committees have also weighed in on real and perceived conflicts. Most recently, the Physician Payments Sunshine Act of 2010 requires companies to begin recording any physician payments, including stock options, research grants, knickknacks, consulting fees, and travel to medical conferences that are worth more than ten dollars in 2012 and report them on March 31, 2013. To date, the American College of Cardiology (ACC) has developed and instituted one of the most stringent policies in the medical community to ensure that support from industry has no influence on any of its clinical documents. Furthermore, the need for the ACC's "Principles for Relationships with Industry," the organization's guide in nine key operational areas, are critical given that, when it comes to industry, properly managed partnerships are absolutely essential to maintaining scientific progress in cardiology and other specialties. The ACC relies on industry funding to advance cardiovascular research, as well as cardiovascular workforce training, practitioner diversity, medical education, and life-long learning. Without this funding, the ACC's ability to provide meaningful, unbiased education and to improve quality of care would be far more limited than that which is currently offered to its members and, ultimately, patients. Rather than restricting industry funding for such activities, the focus should instead be on transparency and actively and appropriately managing industry relationships. Ethical and appropriate partnerships with industry can prove beneficial in funding of education, research, and quality improvement activities. In addition, they are critical in the advancement of the quality of care for patients. The challenge is for medical societies to help the media, the public, and policymakers better understand the role of industry in promoting research, education, and innovation in medicine., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Relationships between physicians and their industry partners have ranged from spectacular collaborations that produce extraordinary advances in patient care, such as endovascular aneurysm repair, to humiliating scandals such as extravagant trips and bogus "consulting" agreements resulting in legal actions. It is the latter which have led many to call for the end of all physician-industry relationships, and the former which mandate their preservation. While these two examples are representative of extremes at each end of the spectrum of this issue, in reality the majority of physician-industry relationships are far more complex, and the line between appropriate and inappropriate, and ethical and unethical, is hard to draw. The benefits of our relationships with industry are many: partnering to develop new therapies and technologies, educating and training physicians around new therapies and technologies, support of continuing medical education (CME), fellowship training, and patient education. The pitfall and danger of this relationship is that support from industry, be it a meal, a pen, an educational grant, or flattery, may unduly and inappropriately influence physician decision making around a specific company's product. While it is clear that free trips are not within the realm of proper interaction, what about unrestricted educational grants to institutions, or support of CME activities, professional society meetings, and new device training? As a result of the intense scrutiny of relationships between physicians and industry recently, multiple diverse entities (Association of American Medical Colleges, American Medical Association, Accreditation Council for Continuing Medical Education, professional medical associations, academic medical centers, industry, and government) have generated guidelines and policies with very different perspectives, reflective of their different missions. These policies range from vague and lenient, with only basic limitation of the physician-industry relationship, to extremely rigid and strict, with only minimal interaction and mission support permitted. Given the many changes in oversight and expectations for the relationship between physicians and industry, it is important for vascular surgeons to be aware of the background behind these modifications, the evidence that they are needed, and the positions of the diverse organizations and institutions that have already defined their policies on this issue., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

If it were not for the ongoing collaboration between vascular surgeons and the medical technology industry, many of these advanced treatments used every day in vascular interventional surgery would not exist. The flip side of this coin is that these vital relationships create multiple roles for surgeons and must be appropriately managed. The dynamic process of innovation, along with factors such as product delivery technique refinement, education, testing and clinical trials, and product support, all make it necessary for ongoing and close collaboration between surgeons and the device industry. This unique relationship sometimes leads to the perception of conflicts of interest for physicians, in part because the competing pressures from the multiple, overlapping roles as clinician/caregiver/investigator/innovator/customer are significant. To address this issue, the Advanced Medical Technology Association (AdvaMed), the nation's largest medical technology association representing medical device and diagnostics companies, developed a Code of Ethics to guide medical technology companies in their interactions with health care professionals. First introduced in 1993, the AdvaMed Code strongly encourages both industry and physicians to commit to openness and high ethical standards in the conduct of their business interactions. The AdvaMed Code addresses many of the types of interactions that can occur between companies and health care professionals, including training, consulting agreements, the provision of demonstration and evaluation units, and charitable donations. By following the Code, companies send a strong message that treatment decisions must always be based on the best interest of the patient., (Copyright © 2011. Published by Mosby, Inc.)

The physician/surgeon's interactions with industry have come under scrutiny in recent years for several reasons. Although some think that the professional medical association or society may provide an avenue to allow such interactions with less risk, there are concerns and challenges for such organizations as it relates to ethical and professional norms of their members. This is one surgeon's review of some pertinent information regarding what the professional medical society provides to its members and what role industry plays in the society's ability to provide these benefits. There is an exploration of the risks involved and practical methods to control inherent conflicts of interest involved in this interaction., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

There has been a dramatic spread of market relationships in many low- and middle-income countries. This spread has been much faster than the development of the institutional arrangements to influence the performance of health service providers. In many countries poor people obtain a large proportion of their outpatient medical care and drugs from informal providers working outside a regulatory framework, with deleterious consequences in terms of the safety and efficacy of treatment and its cost. Interventions that focus only on improving the knowledge of these providers have had limited impact. There is a considerable amount of experience in other sectors with interventions for improving the performance of markets that poor people use. This paper applies lessons from this experience to the issue of informal providers, drawing on the findings of studies in Bangladesh and Nigeria. These studies analyse the markets for informal health care services in terms of the sources of health-related knowledge for the providers, the livelihood strategies of these providers and the institutional arrangements within which they build and maintain their reputation. The paper concludes that there is a need to build a systematic understanding of these markets to support collaboration between key actors in building institutional arrangements that provide incentives for better performance.

The reorganisation efforts of the hospital sector in many Western countries in recent decades have challenged the role, identity and autonomy of medical professionals. This has led to increased focus on the role and impact of physicians who are also managers and on the unique discourse being formed through the integration of medical and managerial knowledge. Following the line of studies addressing the professional subcultures in medicine, we investigated whether assessments of health reform differ between medical doctors with managerial responsibilities and their colleagues at the clinical level as well as between those involved in direct patient care and those who are not. The analysis was performed within the context of the Norwegian hospital sector, where a major reform was implemented in 2002, and it was based on a survey of a representative sample of hospital physicians in 2006. The analysis focused on how the respondents viewed the overall effect of the reform and on the reform's effect on three central health policy goals: equity, quality and productivity. Combining data from the survey with organisational and financial data from the hospitals, we employed multilevel techniques to control for a number of individual and hospital-specific factors that could explain the physicians' views. As expected, respondents with managerial responsibilities were more positive in their evaluations of the reform, whereas respondents who spent time on direct patient-related work showed the opposite pattern. Of the hospital-specific factors of interest, the share of department managers with medical backgrounds and the economic situation positively affected the evaluations. Our findings support the view that, rather than managerialist values colonising the medical profession through a process of hybridisation, there is heterogeneity within the profession: some physician managers are adopting management values and tools, whereas others remain alienated from them., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

The 2010 US Supreme Court Citizens United v Federal Election Commission 130 US 876 (2010) case concerned the plans of a nonprofit organization to distribute a film about presidential candidate Hillary Clinton. The Court ruled that prohibiting corporate independent expenditures for advocacy advertising during election campaigns unconstitutionally inhibits free speech. Corporations can now make unlimited contributions to election advocacy advertising directly from the corporate treasury. Candidates who favor public health positions may be subjected to corporate opposition advertising. Citizen groups and legislators have proposed remedies to ameliorate the effects of the Court's ruling. The public health field needs to apply its expertise, in collaboration with others, to work to reduce the disproportionate influence of corporate political speech on health policy and democracy.

Lingering fallout--loss of jobs and employer coverage--from the great recession slowed demand for health care services but did little to slow aggressive competition by dominant hospital systems for well-insured patients, according to key findings from the Center for Studying Health System Change's (HSC) 2010 site visits to 12 nationally representative metropolitan communities. Hospitals with significant market clout continued to command high payment rate increases from private insurers, and tighter hospital-physician alignment heightened concerns about growing provider market power. High and rising premiums led to increasing employer adoption of consumer-driven health plans and continued increases in patient cost sharing, but the broader movement to educate and engage consumers in care decisions did not keep pace. State and local budget deficits led to some funding cuts for safety net providers, but an influx of federal stimulus funds increased support to community health centers and shored up Medicaid programs, allowing many people who lost private insurance because of job losses to remain covered. Hospitals, physicians and insurers generally viewed health reform coverage expansions favorably, but all worried about protecting revenues as reform requirements phase in.

Brazil has established the largest public kidney transplantation system in the world .46.2% of transplants in 2008 came from living donors. The vast majority of these involved relatives of the recipient; less than 8% came from unrelated donors. In 2008, Brazil's health minister proposed banning unrelated donors in kidney transplantation. A large number of the over 35,000 Brazilians on the waiting list for a kidney would be denied a transplant without the use of unrelated donors. Brazilian culture has a unique feature, the "informal family", that is not legally recognised as a "family entity and is bound by affection rather than genetic or legal ties. It is vital that Brazil establishes a regulated, standardised, and ethical system of organ procurement; creates awareness about transplantation in physicians and the public; upgrades facilities and standardises medical care, and enforces legislation for transplantation. However, outlawing the use of unrelated donors would result in injustice for many patients who seek kidneys.

Recently, in increasing numbers, citizens of wealthy nations are heading to poorer countries for medical care. They are traveling to the global South as medical tourists because in their home nations either they cannot get timely medical care or they cannot afford needed treatments. This essay offers a robust, particularist ethical assessment of the practice of citizens of richer nations traveling to poorer countries for healthcare., (© 2010 Blackwell Publishing Ltd.)

"Medical tourism" has frequently been held to unsettle naturalised relationships between the state and its citizenry. Yet in casting "medical tourism" as either an outside "innovation" or "invasion," scholars have often ignored the role that the neoliberal retrenchment of social welfare structures has played in shaping the domestic health-care systems of the "developing" countries recognised as international medical travel destinations. While there is little doubt that "medical tourism" impacts destinations' health-care systems, it remains essential to contextualise them. This paper offers a reading of the emergence of "medical tourism" from within the context of ongoing health-care privatisation reform in one of today's most prominent destinations: Malaysia. It argues that "medical tourism" to Malaysia has been mobilised politically both to advance domestic health-care reform and to cast off the country's "underdeveloped" image not only among foreign patient-consumers but also among its own nationals, who are themselves increasingly envisioned by the Malaysian state as prospective health-care consumers.