Ten years ago, Jesse Gelsinger died while participating in a human gene therapy trial at the University of Pennsylvania (“Penn”). His death came to signify the corrosive influence of financial interests in human subjects research. After Jesse's death, the media reported that one researcher. Dr. James Wilson, held shares in a biotech company, Genovo, which stood to gain from the research's outcome — shares that The Wall Street Journal later valued at $13.5 million, although Wilson maintains he did not make nearly this much. At the time Penn authorized Wilson's deal, internal Penn documents implicitly valued Wilson's stake in Genovo at approximately $28.5 to $33 million. In 2009, the Institute of Medicine joined a growing chorus of voices that called for significant reforms to the rules governing disclosure of financial conflicts of interest. The IOM and other groups would presumptively bar nearly all equity stakes by researchers like Wilson. Although the IOM's view represents the dominant narrative about financial conflicts of interest, it is not the only one. One influential group urges that financial conflicts can never be removed from medical research and, indeed, should not be. This Essay evaluates these polar positions by examining Jesse's participation in human research and his death. Drawing on new evidence from the documents collected in the Gelsingers' lawsuit, this Essay asks specifically whether new and better restrictions on financial conflicts of interest would have made a difference in Jesse's case and concludes that more robust restrictions would not have mattered. This Essay argues that rather than attempting to expunge financial interests from research, those interests should trigger significant, ongoing review of the affected clinical trials, much like the post-approval monitoring now used randomly by leading research institutions. Indeed, had Wilson's outsized financial stake triggered mandatory monitoring, people inside Penn likely would have stumbled upon the string of questionable decisions in Jesse's trial, including departures from the research protocol, long before those mistakes cascaded, culminating in Jesse's death. This Essay describes the research trial Jesse participated in and the lawsuits spawned by his death, and recaps the cavalcade of errors that the FDA says plagued the trial long before and up to Jesse's death, errors now largely acknowledged by Wilson. Next, this Essay reviews what the researchers told Jesse about the trial's risks, the results of prior animal studies, and the basic protections he would receive as a participant, and contrasts those disclosures with the frank disclosures approved by regulators at the trial's start. This Essay then follows the money, showing the nature and extent of Wilson's financial conflict of interest, and demonstrates that a lot of good people inside Penn sounded alarm bells about Wilson's hefty stake, to no avail. Next, this Essay sketches the precautions suggested by Penn faculty to reduce risks to subjects participating in Wilson's research, such as creating a firewall between Wilson and crucial decisions in Jesse's trial. This Essay then contrasts those proposed precautions with what actually transpired in Jesse's trial, noting the integral role Wilson played in many key decisions. This Essay then evaluates the competing narratives about financial conflicts of interest through the lens of Jesse's trial. Finally, this Essay concludes by examining greater oversight of human trials and monitoring for human safety.

The Death of Jesse Gelsinger: New Evidence of the Influence of Money and Prestige in Human Research

The COVID-19 pandemic has caused a global health crisis. Numerous cancer patients from non-Western countries, including the United Arab Emirates (UAE), seek cancer care outside their home countries and many are sponsored by their governments for treatment. Many patients interrupted their cancer treatment abruptly and so returned to their home countries with unique challenges. In this review we will discuss practical challenges and recommendations for all cancer patients returning to their home countries from treatment abroad. Experts from medical, surgical and other cancer subspecialties in the UAE were invited to form a taskforce to address challenges and propose recommendations for patients returning home from abroad after medical tourism during the SARS-COV-19 Pandemic. The taskforce which consisted of experts from medical oncology, hematology, surgical oncology, radiation oncology, pathology, radiology and palliative care summarized the current challenges and suggested a practical approaches to address these specific challenges to improve the returning cancer patients care. Lack of medical documentation, pathology specimens and radiology images are one of the major limitations on the continuation of the cancer care for returning patients. Difference in approaches and treatment recommendations between the existing treating oncologists abroad and receiving oncologists in the UAE regarding the optimal management which can be addressed by early and empathic communications with patients and by engaging the previous treating oncologists in treatment planning based on the available resources and expertise in the UAE. Interruption of curative radiotherapy (RT) schedules which can potentially increase risk of treatment failure has been a major challenge, RT dose-compensation calculation should be considered in these circumstances. The importance of a thorough clinical handover cannot be overstated and regulatory bodies are needed to prevent what can be considered unethical procedure towards returning cancer patients with lack of an effective handover. Clear communication is paramount to gain the trust of returning patients and their families. This pandemic may also serve as an opportunity to encourage patients to receive treatment locally in their home country. Future studies will be needed to address the steps to retain cancer patients in the UAE rather than seeking cancer treatment abroad.

/pdf/challenges-for-cancer-patients-returning-home-during-sars-2sgiabxqdj.pdf

Challenges for cancer patients returning home during SARS-COV-19 pandemic after medical tourism - a consensus report by the emirates oncology task force.

TO THE EDITOR: The recent commentary by Benedetti et al in Journal of Global Oncology accurately identifies and describes the growing, underestimated, and under-researched area of medical tourism for cancer care and the associated ethical issues arising when patients seek care in international settings. Having been involved on both sides, as the accepting physicians during our practice in the United States and more recently as the referring physicians during our current practice in theUnitedArab Emirates (UAE) andSaudi Arabia, we would like to discuss and clarify some of the ethical and practical issues pertaining to medical tourism for cancer care in our countries. Benedetti et al discussed medical tourism in which patients travel to less developed countries for medical care; however, they were hesitant to define the current practice of patients with cancer from developing countries traveling to developed countries as medical tourism. The definition of medical tourism is broad and simple: “People traveling abroad with the expressed purpose of accessing medical treatment.” This definition is not restricted by the direction of travel to or from developed countries. What is unique about medical tourism by patients traveling from less developed countries is that a significant number of these patients are sponsored by their governments, especially those from oil-rich countries. The UAE spent an estimated US$163 million in 2013 on medical tourism for cancer care. Benedetti et al speculated the reasons for medical tourism included second opinions, research, or specialized care that is unavailable in the patients’ home countries. From our experience, most patients are seeking second opinions rather than participation in clinical trials or specialized care lacking in their own countries. Because of a lack of official data in this regard, it is difficult to quantify the percentage of patients whose cancer care is indeed indicated abroad.We estimate less than 10% of such patients truly require specialized care abroad. This medical tourism results largely, as the authors indicated, from thepatients’ and their families’ belief that newer technologies and better medicine exist abroad, and therefore, patients’ outcomes will be improved overseas.

https://ascopubs.org/doi/pdfdirect/10.1200/JGO.17.00087

Chasing the Cure Around the Globe: Medical Tourism for Cancer Care From Developing Countries.

Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). However, this new paradigm has introduced unique considerations specific to the patients receiving CAR T-cell therapy, including prognostic uncertainty, symptom management, and psychosocial support. With increasing availability, there is a growing need for evidence-based recommendations that address the specific psychosocial needs of the children who receive CAR T-cell therapy and their families. To guide and standardize the psychosocial care offered for patients receiving CAR T-cell therapy, we propose the following recommendations for addressing psychosocial support.

Psychosocial care for children receiving chimeric antigen receptor (CAR) T-cell therapy.

Early diagnosis and treatment of retinoblastoma (Rb), the most common intraocular malignancy, can save both the child's life and vision. However, access to services and hence chances for survival and preserving the eye and its vision vary widely across the globe. Some families have to, or make a choice to, leave their home country to seek planned medical treatment abroad. We aimed to investigate how frequently this cross-border travel occurs and the factors associated with it. A total of 278 Rb centres in 153 countries were recruited to participate in a global cross-sectional analysis of newly diagnosed Rb patients in 2017. Number and proportions of children who travelled from their home country for treatment were analysed by country, continent, socioeconomic stratum and clinical and demographic features. The cohort included 4351 new patients of whom 223 [5.1%, 95% confidence interval 4.5-5.8] were taken across country borders for planned medical treatment. Independently significant predictors of travelling across borders included: being from a country with a smaller population, being from a country classified as low socioeconomic status, having bilateral Rb and having intraocular disease without extraocular spread. The factors that determine international travel for Rb treatment are complex and deserve further investigation. We may need to rethink the way services are delivered in the light of the threat of severe curtailment of international travel from pandemics like corona virus disease 2019.

/pdf/international-travel-to-obtain-medical-treatment-for-primary-4e95xsikpx.pdf

International travel to obtain medical treatment for primary retinoblastoma: A global cohort study.

Medical tourism is the well-described phenomenon in which patients travel to less developed countries formedical care. Far less iswritten about the growing practice of international patients traveling to developed countries for second opinions, research, or specialized care that is unavailable in their home countries. Because cancer care represents a major component of this phenomenon, we becamemotivated to examine the unique ethical challenges of this practice. In this commentary, we identify anddiscuss ethical questions arising in the care of patients from international settings and make suggestions for future work to be done in this evolving area of cancer medicine.

Going the Distance: Ethical Issues Arising When Patients Seek Cancer Care From International Settings

The practice of pediatric oncology presents health-care professionals, patients, and family members with ethical tensions that should provoke discussion and reflection among these various moral stakeholders. For example, medical decision-making has experienced a paradigm shift from the practice of medicine dominated by paternalism to one that champions autonomy. With this shift, the practice of informed consent has become an integral part of oncology practice, yet we lack consensus about what it means to be informed and about how to optimize the roles of children and adolescents in decision-making. In addition, pediatric oncology has achieved dramatic improvement in outcomes due to research on child subjects. Yet the history of research involving children contains numerous examples of practices that exploited and sometimes harmed children who must therefore be considered a vulnerable population of potential research subjects. Also, the care of children with cancer may create a need to provide ethically sound care at the end of life. Despite legal precedent to guide many of our practices in this setting, decisions arising at the end of life continue to present ethical quandaries.

Ethics in Pediatric Oncology

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Going the Distance: Ethical Issues Arising When Patients Seek Cancer Care From International Settings

Ethics in Pediatric Oncology