: Because an influenza pandemic would create the most serious hardships for those who already face most serious hardships, countries should take special measures to mitigate the effect of a pandemic on existing social inequalities. Unfortunately, there is little evidence that anybody is thinking about that.
Emily Largent, Steven Joffe, and Franklin Miller offer a stimulating contribution to the literature on integrating medical research and practice. We agree on both the need to move toward what the Institute of Medicine has called a learning health care system and the need for new conceptions for integrating research and practice within it. We also agree with the authors’ view, first advanced by Robert Truog and colleagues in 1999, that it can be ethically acceptable to randomize patients without express (...) consent in trials comparing widely used, approved interventions that pose no additional risk. With appropriate oversight, learning health care systems ought to conduct such trials on a regular basis. Our .. (shrink)
In this issue of the Report, Daniel Groll suggests new ways to understand old tensions between autonomy and paternalism. He categorizes disagreements between doctors and patients in four ways. Some are about the ends or goals of medical treatment. For these, he claims, patient choices are based upon patient values, and physicians should neither challenge nor assess them. More common are disagreements about the appropriate means to achieve an agreed-upon goal. These subdivide into two distinct categories—those in which the relative (...) efficacy of possible means is “medically assessable” and those in which it is not. When disagreements are medically assessable, Groll argues, doctors can legitimately challenge patient .. (shrink)
If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.
In the 1960s, newborn screening programs tested for a single very rare but serious disorder. In recent years, thanks to the development of new screening technology, they have expanded into panels of tests; a federally sponsored expert group has recommended that states test for twenty-nine core disorders and twenty-five secondary disorders. By the standards used to decide whether to introduce new preventive health services into clinical use, the decision-making in newborn screening policy has been lax.
In the United States, while it is legal for physicians to prescribe drugs for “off-label” indications (uses for which the drugs do not have Food and Drug Administration approval), it is largely—though not entirely—illegal for drug manufacturers to promote off-label uses of their drugs to physicians. In recent months, the rules against off-label marketing have been rigorously enforced: in October, Allergan reached a $375 million settlement over off-label promotion of Botox; in September, Novartis settled an off-label marketing dispute for $422.5 (...) million, and Forest Laboratories settled one for $313 million. These were only the latest in a series of criminal and civil settlements on off-label promotion, the most .. (shrink)
The United Kingdom's coalition government has just begun the most sweeping overhaul of the National Health Service since its inception.1 Under the reforms, 80 percent of the NHS budget will be handed over to about five hundred local consortia of primary care physicians, who will be empowered to make medical spending and allocation decisions for their patients. The 152 existing Primary Care Trusts (PCTs), which purchase hospital and community care for patients and oversee primary care physicians in their regions, will (...) close their doors, leaving local doctors with the power to decide which interventions are appropriate, and which too expensive.2 Hospitals and community service providers will have greater freedom .. (shrink)