An investigation exposes violations to research ethics, finding that researchers failed to disclose risks and even misled government agencies.
A new paper published in Bioethics assesses proposals to “enhance morality” through neuropharmacological and neurotechnological interventions.
For BMJ Blogs, Phoebe Friesen argues that including “personal responsibility” in health care policy can end up penalizing those who engage in stigmatizing behaviors....
Sheila Kaplan for STAT News: “The modern history of science is littered with studies in which participants were harmed because researchers failed to take...
Fierce Pharma reports: "Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and...
After a clinical trial killed one person and landed five others in intensive care, the government is demanding that the clinical trial company responsible, Biotrial,...
Writing for the Atlantic, Emma Yasinski confesses that she was enrolled in a clinical trial for an invasive experimental surgery at seven years old but, as the results were never published, she may never know how well it actually worked.
Marcia Angell in the New York Review of Books writes about the inherent conflict in clinical trials between “the search for scientific answers," on one hand, and “the rights and welfare of human subjects,” on the other.
A California jury ruled that Johnson & Johnson’s Janssen Pharmaceutical and a psychiatrist were responsible for the death of 25-year-old Leo Liu. During a clinical trial for Risperdal, Liu died of a heart injury that was “further complicated” by the drug and ignored by the study doctors. Janssen was found 70% responsible for Liu’s death and ordered to pay $5.6 million to the family.
The University of Minnesota recently announced that it is ending the controversial practice of recruiting study participants from patients involuntarily being held in their psychiatric unit. In a commentary for Minnesota’s Star Tribune, bioethicist and MIA contributor Carl Elliot reports that the university has still not apologized to the patient who spoke out against this practice. Instead, “the university has done its best to discredit him.”
In the Atlantic, Cari Romm describes “what it is like to earn a living as a research subject in clinical trials.” “Phase 1 trials are almost always where the money is,” she writes, but they are “also the least regulated” and “companies aren’t legally required to register a trial with Clinicaltrials.gov.” “It seems to me like if you were considering signing up for one of these things, you would at least want to know the data that’s out there about [safety],” said Carl Elliott, an author for MIA and expert on the ethics of human subject research.
Beginning in the 1990s, a number of pharmaceutical and biotechnology companies began to set up bioethics advisory boards, ostensibly to obtain guidance about controversial ethical issues. Over the years, the ties between industry and bioethics have gradually grown closer, with companies setting up endowed chairs and hiring bioethics consultants. Yet very little is known about how bioethics advisory boards work. What exactly is their purpose? Do they prevent ethical wrongdoing, or do they provide ethical cover?
Carl Elliott writes on the discrepancy between New Zealand's response to a research scandal - which lead to a national debate and dramatic reforms - and the silence following clinical trial scandals in the U.S.