FDA looks on while major U.S. institutions violate medical research rules

“The FDA has issued warnings to only a handful of the companies and institutions with the worst track records of violating a key clinical trial disclosure law, a new report finds.

 

 

Out of 51 large US-based companies and institutions that have failed to make five or more clinical trial results public, only three have been contacted by the U.S. drug regulator, and only one has received a final warning, FDA enforcement data show.

 

 

Failing to rapidly make clinical trial results public on the American trial registry harms patients because it slows down medical progress, leaves gaps in the medical evidence base, and wastes public funds. …”

View of The UGC-CARE initiative: Indian academia’s quest for research and publishing integrity | First Monday

Abstract:  This paper discusses the reasons for emergence of predatory publications in India, engendered by mandates of higher educational institutions: that require stipulated number of research publications for employment and promotions. Predatory journals have eclipsed the merits of open access publishing, compromised ethical practices, and left the research community groping for benchmarks of research integrity and publication ethics. To fight back the menace of predatory publications, University Grants Commission, India has established “Consortium for Academic Research and Ethics” (UGC-CARE) in 2018 to promote and benchmark research integrity and publication ethics among the Indian academia. The present paper discusses the UGC-CARE initiative, its structure, objectives and specifically, “UGC-CARE Reference List of Quality Journals” (UGC-CARE list) and finally, the challenges it faces.

 

Transparency and secrecy in citizen science: Lessons from herping – ScienceDirect

Abstract:  In this paper I will outline a worry that citizen science can promote a kind of transparency that is harmful. I argue for the value of secrecy in citizen science. My argument will consist of analysis of a particular community (herpers), a particular citizen science platform (iNaturalist, drawing contrasts with other platforms), and my own travels in citizen science. I aim to avoid a simple distinction between science versus non-science, and instead analyze herping as a rich practice [MacIntyre, 2007]. Herping exemplifies citizen science as functioning simultaneously within and outside the sphere of science. I show that herpers have developed communal systems of transmitting and protecting knowledge. Ethical concerns about secrecy are inherently linked to these systems of knowledge. My over-arching aim is to urge caution in the drive to transparency, as the concepts of transparency and secrecy merit close scrutiny. The concerns I raise are complementary to those suggested by previous philosophical work, and (I argue) resist straightforward solutions.

 

US Patent Boss Says No Evidence Of Patents Holding Back COVID Treatments, Days Before Pharma Firms Prove He’s Wrong | Techdirt

“A week or so ago, the head of the US Patent and Trademark Office, Andrei Iancu, who has been an extreme patent maximalist over the years, insisted that there was simply no evidence that patents hold back COVID treatments. This is a debate we’ve been having over the past few months. We’ve seen some aggressive actions by patent holders, and the usual crew of patent system supporters claiming, without evidence that no one would create a vaccine without much longer patent terms….

But just to highlight how ridiculous Iancu’s statements were, just days later, Pfizer, Regeneron, and BioNTech — all working on COVID treatments (including the antibody cocktail that President Trump took from Regeneron) — were all sued for patent infringement for their COVID treatments….

So, it certainly appears that patents are getting in the way of some COVID-19 treatments….”