(Press-News.org) Ethical challenges are central to persistent "critical weaknesses" in the national system for ensuring drug safety, according to a commentary by former Institute of Medicine (IOM) committee members published today in the New England Journal of Medicine.
With a caution against "reactive policymaking," committee co-chairs Ruth Faden, Ph.D., M.P.H., and Steven Goodman, M.D., M.H.S., Ph.D., with fellow committee member Michelle Mello, J.D., Ph.D., revisit the controversy over the antidiabetic drug Avandia that led to the formation of their IOM committee on monitoring drug safety after approval.
The Avandia postmarket trial, halted in September 2010, was "a lesson in how our current approach to the oversight of drug-safety and postmarketing research can fail both the public and the research participants," the authors write. With those lessons in mind, their independent commentary follows the May 2012 IOM report with a focus on the ethical challenges ahead.
The authors detail the IOM report's recommendations for maintaining the delicate balance of drug innovation and drug safety. Increased "fast-tracking" of drug approval for medical conditions with no effective treatment necessitates a counterbalance of increased postmarket oversight, the authors argue. They echo the IOM report's call for an independent ethics advisory board to the Food and Drug Administration (FDA), focused on postmarket research and safety surveillance.
"As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the lifecycle of a drug," the authors write.
The authors also amplify one of the IOM report's key ethics points – the responsibility of the FDA to participants in postmarket research, particularly in randomized trials that determine which treatment they receive. The FDA has a unique ethical obligation to the welfare of research participants when requiring a postmarket study, the authors assert, which "cannot be handed off to contractors or the industry sponsor."
"The FDA is uniquely positioned to ensure ethical postmarket research, including a proper informed consent process," says Faden, director of the Johns Hopkins Berman Institute of Bioethics. "Because some postmarket trials are required specifically to address mounting concerns that the drug's risks may outweigh its benefits, there are heightened obligations to ensure that potential research participants understand the risks of enrollment."
The authors also note that the volume of postmarket studies is increasing, due not only to FDA-ordered research but also the growing field of academic comparative-effectiveness research. The ethical issues involved can vary widely, the authors say, which makes clarity about the context for the research crucial. "Depending on who is initiating the research, for what reasons, and when, the same study design may have very different ramifications for the benefit–risk balance of the study and what patients need to know in order to provide meaningful informed consent," the authors write.
###
About the Johns Hopkins Berman Institute of Bioethics
One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, nongovernmental organizations and private sector organizations to address and resolve ethical issues. Institute faculty members represent such disciplines as medicine, nursing, law, philosophy, public health and the social sciences. Their work helps anticipate and inform debates on complex moral challenges, discern ethically acceptable alternatives in medical, scientific and public health policy and help to prepare the next generation of bioethicists. More information is available at www.bioethicsinstitute.org.
END
For six months last year, a deadly outbreak of antibiotic-resistant bacteria kept infection-control specialists at the National Institutes of Health's (NIH) Clinical Center in a state of high alert. A New York City patient carrying a multi-drug resistant strain of Klebsiella pneumoniae, a microbe frequently associated with hospital-borne infections, introduced the dangerous bacteria into the 243-bed research hospital while participating in a clinical study in the summer of 2011.
Despite enhanced infection-control practices, including patient isolation, the K. pneumoniae ...
NEW YORK, August 22, 2012 – Researchers at NYU School of Medicine have made a novel discovery that could have widespread clinical implications, potentially affecting everything from nutrient metabolism to obesity in children.
Since the 1950's, low dose antibiotics have been widely used as growth promoters in the agricultural industry. For decades, livestock growers have employed subtherapeutic antibiotic therapy (STAT), not to fight infection or disease, but to increase weight gain in cattle, swine, sheep, chickens and turkey, among other farm animals.
First author ...
Irvine, Calif. – Increased capture of natural gas from oil fields probably accounts for up to 70 percent of the dramatic leveling off seen in atmospheric methane at the end of the 20th century, according to new UC Irvine research being published Thursday, Aug. 23, in the journal Nature.
"We can now say with confidence that, based on our data, the trend is largely a result of changes in fossil fuel use," said chemistry professor Donald Blake, senior author on the paper.
Methane has 20 times the global warming potential of carbon dioxide, although CO2 is filling the ...
A low dose of the sedative clonazepam alleviated autistic-like behavior in mice with a mutation that causes Dravet syndrome in humans, University of Washington researchers have shown.
Dravet syndrome is an infant seizure disorder accompanied by developmental delays and behavioral symptoms that include autistic features. It usually originates spontaneously from a gene mutation in an affected child not found in either parent.
Studies of mice with a similar gene mutation are revealing the overly excited brain circuits behind the autistic traits and cognitive impairments ...
Scientists at the University of Liverpool have found that the worm which causes River Blindness survives by using a bacterium to provide energy, as well as help 'trick' the body's immune system into thinking it is fighting a different kind of infection.
River Blindness affects 37 million people, mainly in sub-Saharan Africa, causing intense itching of the skin, visual impairment and in severe cases, irreversible blindness. It is caused by a parasitic worm that is transmitted by blood-feeding blackflies, which breed in fast-flowing rivers.
The team at Liverpool investigated ...
Results published this week by a team of polar scientists from Britain, Australia and France adds a new dimension to our understanding of Antarctic Peninsula climate change and the likely causes of the break-up of its ice shelves.
The first comprehensive reconstruction of a 15,000 year climate history from an ice core collected from James Ross Island in the Antarctic Peninsula region is reported this week in the journal Nature. The scientists reveal that the rapid warming of this region over the last 100 -years has been unprecedented and came on top of a slower natural ...
A new class of organic materials developed at Northwestern University boasts a very attractive but elusive property: ferroelectricity. The crystalline materials also have a great memory, which could be very useful in computer and cellphone memory applications, including cloud computing.
A team of organic chemists discovered they could create very long crystals with desirable properties using just two small organic molecules that are extremely attracted to each other. The attraction between the two molecules causes them to self assemble into an ordered network -- order ...
Female sea slugs mate more frequently than required to produce offspring, despite the highly traumatic and biologically costly nature of their copulation, as reported Aug. 22 in the open access journal PLOS ONE.
The authors of the study, led by Rolanda Lange of the University of Tuebingen in Germany, investigated the mating behavior of a simultaneously hermaphroditic species of sea slug that mates via an extravagant ritual that involves a syringe-like penile appendage that stabs the partner to inject prostate fluids and sperm.
Surprisingly, the researchers found that ...
Managers and non-managers show distinctly different brain activation patterns when making decisions, according to research published Aug. 22 in the open access journal PLOS ONE.
The authors of the study, led by Svenja Caspers of the Institute of Neuroscience and Medicine, Research Centre Jülich in Germany, used functional MR imaging to track the decision making process for managers and non-managers. Subjects were required to perform equally repetitive decisions, one form of decision making occurring in every-day work life. The authors found that manager and non-managers ...
Approximately one in five prescriptions to elderly people is inappropriate, according to a study published Aug. 22 in the open access journal PLOS ONE.
The authors of the study, led by Dedan Opondo of the Academic Medical Center in Amsterdam, conducted a systematic review of English-language studies of medication use in the elderly and found that the median rate of inappropriate prescriptions was 20.5%. Some of the medications with the highest rates of inappropriate use were the antihistamine diphenhydramine, the antidepressant amitriptyline, and the pain reliever propoxyphene.
INFORMATION:
Citation: ...
