While a World Health Organization (WHO) advisory panel says it is ethical to use experimental medications and vaccines on Ebola patients, experts caution that these drugs are not without risks, and physicians must carefully triage patients or risk serious adverse events, according to a commentary being published in Annals of Internal Medicine.
The WHO's epidemic-specific conclusion mandates that health care professionals employ particular ethical standards (fairness of dissemination, patient consent, physician nonmaleficence) when using unapproved Ebola drugs.
AdvertisementTherein lies the problem, according to the authors. Because the drugs are experimental, physicians will not be able to discern which patients are likely to benefit from treatment. Drug misuse may lead to poorer outcomes for the 'treated' severely ill, missed opportunities for realistically treatable patients, and a possible induction of drug resistance.
The authors also suggest that meaningful informed consent may not be possible during this current epidemic. They urge physicians to employ careful triage strategies to maintain principled experimentation. Data and safety monitoring and experimentation protocols with plans for adequate drug supply to allow sufficient research will be required to ensure a better future standard.
1. Health economists find major flaw in FDA's tobacco label regulation cost-benefit analysis
The FDA's cost-benefit analysis of its proposed cigarette labeling regulation has a major flaw, according to an Ideas & Opinions piece being published in Annals of Internal Medicine. Federal agencies proposing any significant regulatory action are required to evaluate the regulation's costs and benefits. In this case, the FDA evaluated its proposed rule requiring cigarette packs to bear large graphic warning labels to deter consumers from smoking.
Among other components (costs of implementation, FDA administrative and enforcement costs), the FDA included the cost to consumers, or "consumer surplus." The consumer surplus is the pleasure smokers derive from smoking over and above the price they pay for cigarettes. A group of prominent health economists say that including "lost pleasure" from tobacco use as an element of economic impact is flawed thinking because most tobacco users derive little consumer surplus from smoking.
Rather they struggle with trying to break an addiction, regret having ever started smoking, and face psychological costs from being addicted and unable to quit. The authors urge the FDA to consider this reality in future economic evaluations of proposed tobacco regulations.
2. National study is first to report on medical resident knowledge of High Value Care via exam vignettes
High Value Care sub-scores from the Internal Medicine In-Training Examination (IM-ITE) reflect the importance of training medical residents to understand the benefits, harms, and costs of tests and treatments, according to a study published today in Annals of Internal Medicine. The IM-ITE is a multiple-choice exam developed by the American College of Physicians (ACP) in collaboration with the Alliance for Academic Internal Medicine (AAIM) to help residents along with their program directors assess their knowledge of internal medicine and identify areas for improvement.
ACP has a High Value Care initiative, including a curriculum for residents co-developed with AAIM, to help doctors and patients understand the benefits, harms, and costs of tests and treatment options for common clinical issues so they can pursue care together that improves health, avoids harms, and eliminates wasteful practices. ACP and AAIM identified 38 of 340 questions in the 2012 IM-ITE to create a High Value Care sub-score.
The authors found that the HVC sub-scores correlated strongly with overall IM-ITE performance and there was some association between medical resident sub-scores and the care intensity of the training hospital. The most common associated HVC competency was managing conservatively when appropriate (i.e., including allowing adequate time for clinical improvement, observation and monitoring, or comparison to prior studies rather than additional diagnostic testing).