Blog Posts (8)
November 26, 2013
As the holiday season comes into full swing many of us may visit shopping centers in search of gifts. When we do we’re expecting to see seasonal decorations and perhaps an area cordoned off for Santa and his photo-taking elves. Few of us probably...
November 19, 2013
Here is an article that I wrote for the Hastings Center Report describing the problem of missing and misleading information about our medicines and what to do about it.
Abstract. In 1971, President Richard Nixon declared a “war against cancer,
October 26, 2013
[The Atlantic Wire] The Bowery Bum has long been a symbol of urban dissolution: a 1931″composite profile” in The New Yorker titled, aptly enough, “Bowery Bum,” noted of its subject, John McGoorty, “The extent of his drin...
September 18, 2013
by Thaddeus Pope JD Ph.D.
Intensive care clinicians and clinical ethicists have long known that the provision of interventions perceived to be “futile” is a major problem in U.S.…
September 16, 2013
by Maurice Bernstein MD
Informed consent is the ethical and legal hallmark for the support of patient decision-making in medicine. Though the ethics of patient communication of facts without deceit has been part of medical consideration for generations, it wasn’t until the landmark decision Schloendorff v The Society of the New York Hospital in 1914 that informed consent became United States law. Informed consent has been also been emphasized from the aspect of medical ethics, in recent decades, as decision making has moved from physician paternalism to patient autonomy. Patients awaiting medical/surgical procedures are currently given variable content and amounts of information about their illness and the procedure itself and the risks and outcomes anticipated.…
June 20, 2013
Maurice Bernstein, MD
Gawking, defined in Merriam-Webster dictionary as “to gape or stare stupidly.” It is the “stupidly” which I think sets the ethics of the behavior. The “stupidly” can represent more than some ignorance of what is being observed but also a lack of true purpose at the time of the observation for either understanding or even participation. Gawking is directed primarily for self-interest of the gawker and for no other purpose. A general example of gawking can be given as motorists stopping briefly at an automobile accident simply to observe the trauma but not with an intent to provide assistance. A more specific example of gawking was described in the Associated Press article November 12 2012 in the aftermath of Hurricane “Sandy”:
Garbage trucks, hulking military vehicles and mud-caked cars move slowly through a Staten Island waterfront neighborhood still reeling from Superstorm Sandy’s storm surge.…
February 13, 2010
Why do patients cooperate with medical researchers? So asks sociologists Mary Dixon-Woods and Carolyn Grant in a study analysis appearing in the June 2009 issue of Social Science and Medicine. You might think the answer is simple: they think they will...
December 4, 2009
Clinical researchers have long claimed that patients who enter clinical trials are better off medically than those who don't. I'm open to the notion that patients might derive personal meaning from trial participation, but I've always been dubious of the suggestion that trial participation in itself is therapeutically beneficial–above and beyond drugs received– in part because this has never been demonstrated in a convincing way. I've also worried about the way the "trial effect" has been occasionally mobilized to recruit patients, or to apologize for studies of dubious design. Last, I've worried about the ethical implications of the prospect that, in order to receive top quality care, patients should be enrolling in (or have access to) clinical trials.
One reason I have been skeptical of the "trial effect" is that trials do not enroll a random sample of patients. Ethical research requires informed consent, and if patients who consent to trials have different characteristics than those who decline, it seems plausible that they will have different medical courses. UK researchers led by Andrew Clark recently put this thesis to the test (Eur J Heart Failure; also reported in the December issue of Nature Medicine). In their study, they asked a large sample of patients whether they were willing to enter a clinical trial. They then followed the clinical course of patients who declined, and compared them with patients who consented to participation but were never enrolled in a clinical trial. They found that patients who accepted enrollment had better clinical outcomes- even when factors like age, other sicknesses, or drug use. The finding raises a number of interesting questions about tensions between study validity and informed consent. It does not suggest that we should relax consent standards to reduce bias- though some may be tempted to view the study in this way. It does, however, raise questions about how findings in clinical trials should be interpreted when applying them in real clinical settings. And it provides another problem for those who are attached to the position that trial participation is, in itself, therapeutic. (photo credit: funkandjazz, Skew, 2007)
September 27, 2013 2:22 pm
The Pennsylvania’s Medical Care Availability and Reduction of Error Act specifically gives patients the right to ask questions of physicians, not just physician assistants or nurses.
August 27, 2013 1:03 pm
Two UC Davis neurosurgeons who intentionally infected three brain-cancer patients with bowel bacteria have resigned their posts after the university found they had “deliberately circumvented” internal policies. The surgeons maintain they were acting in the best interests of their desperately ill patients, whose prognoses for survival were poor.
August 14, 2013 6:32 pm
As the modernization of the informed consent process looks to keep patients better informed with electronic presentations of trial information, sponsors and CRO may also utilize the tech to track more data.
July 2, 2013 1:41 pm
Informed consent and a change in privacy rules are what most people seem to be concerned about. However, data by itself is not intelligent. There are equal-parts rules and tools for data to become actionable information.
June 5, 2013 5:16 pm
A group of scholars and leaders in bioethics and pediatrics with extensive experience in ethical and regulatory issues in pediatrics and human subjects research urged the OHRP to withdraw its research violation notification to the institutions involved in SUPPORT.
May 21, 2013 2:37 pm
In a landmark move in the sphere of clinical trials, informed consent of patients participating in clinical trials will soon be recorded on camera.
February 28, 2013 12:49 pm
Would you eat horsemeat? A lot of people would not. Should you have the right to know if the meat you are eating contains horsemeat? The answer to that question is a resounding yes…
July 12, 2012 12:29 pm
Prisoners inside the U.S. military’s detention center at Guantanamo Bay were forcibly given “mind altering drugs,” including being injected with a powerful anti-psychotic sedative used in psychiatric hospitals. Prisoners were often not told what medications they received, and were tricked into believing routine flu shots were truth serums. It’s a serious violation of medical ethics, made worse by the fact that the military continued to interrogate prisoners while they were doped on psychoactive chemicals.
July 9, 2012 9:08 pm
Hospitals may be depriving elderly patients of food and drink to hasten their deaths as part of cost-cutting measures to free up bed space, leading doctors warn. The six doctors are experts in elderly care and wrote the letter in conjunction with the Medical Ethics Alliance, a Christian medical organisation. They say that many members of the public have contacted them with examples of inappropriate use of the pathway, which is implemented in up to 29 per cent of hospital deaths.
June 21, 2012 1:19 pm
The example points to a broad problem in research on humans — that informed consent is often not very well informed (see ‘Reading between the lines’). Protections for participants have been cobbled together in the wake of past controversies and have always been difficult to uphold. But they are proving even more problematic in the ‘big data’ era, in which biomedical scientists are gathering more information about more individuals than ever before. Many studies now include the collection of genetic data, and researchers can interrogate those data in a growing number of ways. Several US states, including California, are considering laws that would curtail the way in which researchers, law-enforcement officials and private companies can use a person’s DNA.
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