Biomedical subjects
Ezekiel J Emanuel
Publications and source records attributed to Ezekiel J Emanuel.
Patients' views on financial conflicts of interest in cancer research trials.
BACKGROUND: Financial ties between researchers or medical centers and companies whose drugs are being tested have come under increasing scrutiny. METHODS: We conducted in-person interviews with 253 patients in cancer-research trials (a 93% response rate) at five U.S. medical centers to determine their attitudes regarding potential financial conflicts of interest among researchers and medical centers. RESULTS: More than 90% of patients expressed little or no worry about financial ties that researchers or institutions might have with drug companies. Most patients said they would have enrolled in the trial even if the drug company had paid the researcher for speaking (82% of those interviewed) or consulting (75%) or if the researcher had received royalty payments (70%) or owned stock in the company (76%). Similarly, most patients would have enrolled in the trial if their cancer center had owned stock in the drug company (77%) or received royalty payments from the company (79%). Most patients believed it was ethical for researchers to receive speaking fees (81%) or consulting fees (82%) from the company. However, a substantial minority of patients wanted disclosure of the oversight system for researchers (40%) and of researchers' financial interests (31%); 17% thought no disclosure to patients was necessary. CONCLUSIONS: Most patients in cancer-research trials were not worried about financial ties between researchers or medical centers and drug companies and would still have enrolled in the trial if they had known about such financial ties. A substantial minority wanted to be informed about the oversight system to protect against financial conflicts of interest and about researchers' financial interests.
Patients' decision-making process regarding participation in phase I oncology research.
PURPOSE: This study assesses the decision-making process of patients enrolling in phase I oncology studies. PATIENTS AND METHODS: Participants were eligible if they had consented to participate in a phase I cancer study at one of five cancer centers, understood English, and were older than 18 years. Trained interviewers conducted structured in-person interviews. RESULTS: Of the 163 participants, 88% were white, 96% had health insurance, and 51% were college graduates or post graduates. Overall, 81% were aware of hospice, but only 6% had seriously considered hospice for themselves; 84% were aware of palliative care and 10% seriously considered it for themselves; and 7% considered getting no treatment at all. Overall, 75% reported moderate or a lot of pressure to participate in the phase I study because their cancer was growing, whereas 7% reported such pressure from the study investigators and 9% felt such pressure from their families. For 63% of patients, the most important information for decision making was that the phase I drug killed cancer cells; only 12% reported that the adverse effects of the drug(s) was the most useful information. More than 90% of patients said they would still participate in the study even if the experimental drug caused serious adverse effects, including a 10% chance of dying. CONCLUSION: Patients are aware of many alternatives to phase I studies, but do not seriously consider them. Very few experience pressure from family or researchers to participate in research. Their main goal is to fight their cancer, and almost no adverse effect, including death, would dissuade them from enrolling.
Changing premed requirements and the medical curriculum.
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Medicare's requirement for research participation as a condition of coverage: is it ethical?
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Circumcision and HIV prevention research: an ethical analysis.
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Should society allow research ethics boards to be run as for-profit enterprises?
BACKGROUND TO THE DEBATE: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval.
Public health. Who should get influenza vaccine when not all can?
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Results of the National Initiative for Cancer Care Quality: how can we improve the quality of cancer care in the United States?
PURPOSE: In 1999, the National Cancer Policy Board called attention to the quality of cancer care in the United States and recommended establishing a quality monitoring system with the capability of regularly reporting on the quality of care for patients with cancer. METHODS: Using data from a patient survey 4 years after diagnosis and review of medical records, we determined the percentage of stage I to III breast cancer and stage II to III colorectal cancer survivors in five metropolitan statistical areas (MSAs) across the United States who received recommended care specified by a comprehensive set of explicit quality measures. RESULTS: Two thousand three hundred sixty-six (63%) of 3,775 eligible patients responded to the survey, and 85% consented to have their medical records reviewed. Our final analytic sample (n = 1,765) included 47% of the eligible patients. Patients with breast and colorectal cancer received 86% of recommended care (95% CI, 86% to 87%) and 78% of recommended care (95% CI, 77% to 79%), respectively. Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and significant variation across MSAs was observed for seven quality measures. The percent adherence was less than 85% for 14 of the 25 colorectal cancer measures, and one quality measure demonstrated statistically significant variation across the MSAs. CONCLUSION: Initial management of patients with breast and colorectal cancer in the United States seemed consistent with evidence-based practice; however, substantial variation in adherence to some quality measures point to significant opportunities for improvement.
Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study.
Controversy exists regarding an ethical requirement to make products proven effective in research available after the trial. Little is known about the views of several stakeholders. Phone or self-administered questionnaires were completed by 65 IRB/REC chairs, 117 investigators, and 500 research participants in a multinational HIV trial to assess their views about posttrial access to interventions proven effective in the study. A total of 83% of research participants, 29% of IRB/REC chairs, and 42% of researchers (p = 0.046) thought IL-2 should be guaranteed for every HIV-infected person in the world if proven effective. Most European and Latin American research participants thought IL-2 should be provided free, while North American, Australian, and Thai participants commonly said at a price the average person could afford (p < 0.001). Most IRB/REC chairs and researchers thought the CIOMS "reasonable availability" requirement applied to people in the country where the study was conducted and meant a drug should be available at a price the average person could afford and that host country governments had primary responsibility for making it available. Most research participants believe an HIV drug proven effective in research should be made available to everyone in the world who needs it. IRB/REC chairs and researchers were less expansive both in who and how they thought a drug should be guaranteed.
Does random treatment assignment cause harm to research participants?
BACKGROUND: Some argue that by precluding individualized treatment, randomized clinical trials (RCTs) provide substandard medical care, while others claim that participation in clinical research is associated with improved patient outcomes. However, there are few data to assess the impact of random treatment assignment on RCT participants. We therefore performed a systematic review to quantify the differences in health outcomes between randomized trial participants and eligible non-participants. METHODS AND FINDINGS: Studies were identified by searching Medline, the Web of Science citation database, and manuscript references. Studies were eligible if they documented baseline characteristics and clinical outcomes of RCT participants and eligible non-participants, and allowed non-participants access to the same interventions available to trial participants. Primary study outcomes according to patient group (randomized trial participants versus eligible non-participants) were extracted from all eligible manuscripts. For 22 of the 25 studies (88%) meeting eligibility criteria, there were no significant differences in clinical outcomes between patients who received random assignment of treatment (RCT participants) and those who received individualized treatment assignment (eligible non-participants). In addition, there was no relation between random treatment assignment and clinical outcome in 15 of the 17 studies (88%) in which randomized and nonrandomized patients had similar health status at baseline. CONCLUSIONS: These findings suggest that randomized treatment assignment as part of a clinical trial does not harm research participants.
"Physician-assisted suicide among Oregon cancer patients": a fading issue.
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Technology licensing: lessons from the US experience.
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The cost of marginal medicine is too high.
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The patents-based pharmaceutical development process: rationale, problems, and potential reforms.
The pharmaceutical industry is facing substantial criticism from many directions, including financial barriers to access to drugs in both developed and developing countries, high profits, spending on advertising and marketing, and other issues. Underlying these criticisms are fundamental questions about the value of the current patent-based drug development system. Six major problems with the patent system are (1) recovery of research costs by patent monopoly reduces access to drugs; (2) market demand rather than health needs determines research priorities; (3) resources between research and marketing are misallocated; (4) the market for drugs has inherent market failures; (5) overall investment in drug research and development is too low, compared with profits; and (6) the existing system discriminates against US patients. Potential solutions fall into 3 categories: change in drug pricing through either price controls or tiered pricing; change in drug industry structure through a "buy-out" pricing system or with the public sector acting as exclusive research funder; and change in development incentives through a disease burden incentive system, orphan drug approaches, or requiring new drugs to demonstrate improvement over existing products prior to US Food and Drug Administration approval. We recommend 4 complementary reforms: (1) having no requirement to test new drug products against existing products prior to approval but requiring rigorous comparative postapproval testing; (2) international tiered pricing and systematic safeguards to prevent flow-back; (3) increased government-funded research and buy-out for select conditions; and (4) targeted experiments using other approaches for health conditions in which there has been little progress and innovation over the last few decades.
Physicians advising investment firms.
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Depression, euthanasia, and improving end-of-life care.
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Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit.
United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments. Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research. Current data reveal that car trips pose the highest risk of mortality ordinarily encountered by healthy children. On average, these risks are approximately 0.06 per million for children aged 14 years and younger, and approximately 0.4 per million for children aged 15 through 19 years. Riskier, but still ordinary, car trips pose an approximately 0.6 per million chance of death for children aged 14 years and younger and an approximately 4 per million chance of death for children aged 15 through 19 years. Participation in sports represents the upper end of the range of morbidity risks for healthy children. For every million instances of playing basketball, approximately 1900 individuals will sustain injuries, including 180 broken bones and 58 permanent disabilities. These findings suggest IRBs are implementing the federal minimal risk standard too cautiously in many cases. These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards.