Maryland Gives Up on Its Library E-book Law

“Maryland’s library e-book law is effectively dead. In a court filing this week, Maryland Attorney General Brian E. Frosh said the state would present no new evidence in a legal challenge filed by the Association of American Publishers, allowing the court’s recently issued preliminary injunction blocking the law to stand, and paving the way for it to be converted into a permanent injunction. …

First introduced in January 2021, the Maryland law required any publisher offering to license “an electronic literary product” to consumers in the state to also offer to license the content to public libraries “on reasonable terms” that would enable library users to have access. The bill passed the Maryland General Assembly unanimously on March 10, and went into effect on January 1, 2022.

The law emerged after a decade of tension in the digital library market, with libraries long complaining of unsustainable, non-negotiated high prices and restrictions. More specifically, however, the law emerged as a direct response to Macmillan’s (since abandoned) 2019 embargo on frontlist e-book titles, which prompted numerous appeals to both federal and state legislators to protect basic access to digital works in libraries. …”

European parliamentarians urge action on missing clinical trial results

“A cross-party group of members of the European parliament has sent an open letter to regulators urging them to not drop the ball on over 3,400 clinical trial results that are still missing on the EudraCT trial registry, in violation of long-standing transparency rules.

 

 

Under European rules, institutions running investigative drug trials must make their results public within 12 months of trial completion. While the rules are set at the European level, responsibility for encouraging and enforcing compliance lies with the national medicines regulators in each country….”

Goodbye, world! OER World Map Blog

The North-Rhine Westphalian Library Service Centre (hbz) will cease operating the OER World Map on 2022-04-29. We would like to thank all those who have supported and promoted the project in recent years. hbz will provide an appropriate solution for archiving the collected data. The software and data are openly licensed, so it is possible to continue operating the platform. If you are interested in continuing to operate the OER World Map, please do not hesitate to contact us at info@oerworldmap.org.  

Proposal for a Digital Services Act — Research, Education, and Science as Collateral Damage – LIBER Europe

“Schools and universities are highly reliant on the multiple digital platforms and infrastructures that provide services to students, teachers, and researchers. It is therefore surprising that the Digital Services Act (DSA) does not consider the impact that this new regulation will have on education and Open Science.

In fact, despite high levels of public investment in education and research, infrastructures (such as institutional and national repositories as well as platforms like Zenodo, the European Open Science Cloud, arXiv.org etc.), they do not feature at all in the European Commission’s impact assessment, nor are they mentioned in the draft Digital Services Act….”

Substantial delays in clinical data published by the European Medicines Agency – a cross sectional study – Journal of Clinical Epidemiology

Abstract:  

Background

Reporting bias poses a fundamental threat to the transparency and validity of interpretations of clinical trials, which may, in part, be mitigated through access Clinical Study Reports (CSRs). The European Medicines Agency (EMA), under their Policy 0070, prospectively publishes clinical data, including CSRs, submitted as part of marketing authorization applications or post-authorization procedures, although this practice is currently suspended for non-COVID-19 medicines, and have set out planned timelines for publication.

 

Methods

We conducted a cross-sectional study assessing the content and characteristics of all clinical data packages released by the EMA under Policy 0070 and the time to their publication. We extracted the number and characteristics of trials included in the clinical packages, assessed the delay to publication relative to the EMAs planned timeline and whether it differed between the EMAs various transparency measures and types of application procedures.

 

Results

We identified 148 clinical data packages that contained data on a total of 1,005 clinical trials, of which 261 (26%) were labelled as phase 3 trials. Full CSRs were available for 913 (90•8%) of the trials. The median time to publication was 511 (IQR 411 to 574) days. Only 2 (1•4%) of the clinical data packages were published within the EMA’s planned timeline. The delay was shorter for clinical data packages released under the EMAs transparency measures for COVID.19 medicines compared with their standard transparency measure.

 

Conclusion

The clinical data packages released by the EMA under Policy 0070 contained CSRs on many trials but were published with considerable delays relative to the timeline set forth by the EMA, reducing their potential impact on reporting bias.

Where are the Clinical Study Reports we were promised?

“Years ago, the European Medicines Agency announced that it would proactively make CSRs accessible to independent researchers. It was the first regulator worldwide to do so. Medical researchers strongly applauded the move. (Health Canada has since launched a similar transparency effort.)

 

 

However, new research shows that the European Medicines Agency’s efforts have lagged far behind its own disclosure targets. …”

Mozilla adds tiered subscription plans to MDN Web Docs • The Register

“The Mozilla Developer Network, which hosts free, open access to web standard documentation, tools, samples and other good stuff, is going pay-for-play with a premium subscription plan that adds new personalization features. 

The Firefox maker announced today the subscription service, called MDN Plus, saying it will add three features for paid MDN users at launch: Notifications, collections, and MDN Offline….”

The ratchet: even demonstrably ineffectual and unnecessary copyright laws are never repealed – Walled Culture

“nd here is what the European Commission’s own evaluation found:

The economic impact of the “sui generis” right on database production is unproven. Introduced to stimulate the production of databases in Europe, the new instrument has had no proven impact on the production of databases….”

The report also wrote that the “empirical evidence, at this stage, casts doubts” on the need for a special copyright for a thriving database industry. So you might think that the obvious, rational thing to do would be to repeal an ineffectual, unneeded monopoly. Instead, the report noted that repealing the directive “would probably lead to considerable resistance by the EU database industry.” In other words, purely because the copyright industry would whine about it, the European Commission’s report recommended leaving in place a law that by its own research was shown to be pointless.

 

This is a perfect example of the copyright ratchet: the fact that copyright always gets longer, stronger, and broader, and that once passed, copyright laws are never weakened or repealed. It’s one of the reasons why copyright is such a disaster today. Its laws were framed for the analogue world, and the copyright industry refuses to countenance updating them to make them fit for the digital world. Indeed, as the upload filters in the EU’s horribly-misnamed Directive on Copyright in the Digital Single Market show, new laws are actively making things worse.”

New Zealand is about to commit copyright theft – the real kind – Walled Culture

“Whatever you might think of the original bargain, it is now demonstrably far worse. In 1710, copyright’s monopoly lasted 14 years, with an additional 14 years if the creator was still alive at the end of that period. Today, in most parts of the world, the monopoly lasts for the life of the creator plus 70 years. Typically, that is over a hundred years from the date of creation, far longer than the modest 14 years of the Statute of Anne.

New Zealand is something of an outlier here. Its copyright term is life plus 50 years. That’s already a long time, but not long enough for the copyright maximalists, who are always working towards their evident goal of perpetual copyright. And it looks like they are going to notch up another victory, as a blog post by Michael Wolfe on the Newsroom site explained last year. An in-principle trade deal between New Zealand the UK will see the former’s copyright term of life plus 50 years become life plus 70 years. What’s remarkable is that extending copyright makes no sense, and the New Zealand government knows it….”

The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects

The agency has withheld critical data on boosters, hospitalizations and, until recently, wastewater analyses.

Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study – Nicholas J DeVito, Ben Goldacre, 2022

Abstract:  Background/Aims:

The European Union Clinical Trials Register is a public facing portal containing information on trials of medicinal products conducted under the purview of the European Union regulatory system. As of September 2021, the registry holds information on over 40,000 trials. Given its distinct regulatory purpose, and results reporting requirements, the European Union Clinical Trials Register should be a valuable open-source hub for trial information. Past work examining the European Union Clinical Trials Register has suggested that data quality on the registry may be lacking. We therefore set out to examine the quality and availability of trial data on the registry with a focus on areas that fall under the authority of regulators in each European Union/European Economic Area country.

Methods:

Using data scraped from the full European Union Clinical Trials Register public dataset, we examined the extent of issues with three areas of trial data availability linked to European Union regulations. We examined whether there is evidence for missing registration of protocols in the public database, whether information on the completion of clinical trials is being made available and how often the results of trials are posted to the registry. We assessed each area overall, and examined variation between national regulators and over time.

Results:

Major issues with the availability of expected protocols and information on trial completion were focused in a few countries. Overall, when comparing enrolment countries from tabular results to available registrations, 26,932 of 31,118 (86.5%) expected protocols were available and 22 of 30 (73%) countries had over 90% of expected protocols available. The majority of missing protocols, totalling 2764 (66%), were from just three countries: France, Norway and Poland. Evidence for this issue is further supported by data on trends in new registrations by country over time. Low availability of data on trial completion is also most pronounced in a minority of countries, like Spain and the Netherlands, with consistent trends for missingness over time. Finally, overall results availability is substantially worse among the 23,623 trials with a single registered European Union protocol (n = 6259, 26.5%) compared to 13,897 of those taking place in multiple countries (n = 8423, 60.6%). Reporting for single-protocol trials was consistently low across both time and location.

Conclusion:

Deficiencies in the public availability of trial protocols, trial completion information and summary results complicate the utility of the European Union Clinical Trials Register for research, transparency and accountability efforts. Users of the registry would benefit from a more complete and accurate accounting of the European research environment via the official European Union registry. We recommend regulators at the national and pan-national level undertake routine audits of approved trials to ensure national-level issues are proactively and transparently identified, documented and addressed.

Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study – Nicholas J DeVito, Ben Goldacre, 2022

Abstract:  Background/Aims:

The European Union Clinical Trials Register is a public facing portal containing information on trials of medicinal products conducted under the purview of the European Union regulatory system. As of September 2021, the registry holds information on over 40,000 trials. Given its distinct regulatory purpose, and results reporting requirements, the European Union Clinical Trials Register should be a valuable open-source hub for trial information. Past work examining the European Union Clinical Trials Register has suggested that data quality on the registry may be lacking. We therefore set out to examine the quality and availability of trial data on the registry with a focus on areas that fall under the authority of regulators in each European Union/European Economic Area country.

Methods:

Using data scraped from the full European Union Clinical Trials Register public dataset, we examined the extent of issues with three areas of trial data availability linked to European Union regulations. We examined whether there is evidence for missing registration of protocols in the public database, whether information on the completion of clinical trials is being made available and how often the results of trials are posted to the registry. We assessed each area overall, and examined variation between national regulators and over time.

Results:

Major issues with the availability of expected protocols and information on trial completion were focused in a few countries. Overall, when comparing enrolment countries from tabular results to available registrations, 26,932 of 31,118 (86.5%) expected protocols were available and 22 of 30 (73%) countries had over 90% of expected protocols available. The majority of missing protocols, totalling 2764 (66%), were from just three countries: France, Norway and Poland. Evidence for this issue is further supported by data on trends in new registrations by country over time. Low availability of data on trial completion is also most pronounced in a minority of countries, like Spain and the Netherlands, with consistent trends for missingness over time. Finally, overall results availability is substantially worse among the 23,623 trials with a single registered European Union protocol (n = 6259, 26.5%) compared to 13,897 of those taking place in multiple countries (n = 8423, 60.6%). Reporting for single-protocol trials was consistently low across both time and location.

Conclusion:

Deficiencies in the public availability of trial protocols, trial completion information and summary results complicate the utility of the European Union Clinical Trials Register for research, transparency and accountability efforts. Users of the registry would benefit from a more complete and accurate accounting of the European research environment via the official European Union registry. We recommend regulators at the national and pan-national level undertake routine audits of approved trials to ensure national-level issues are proactively and transparently identified, documented and addressed.

Penguin Random House Demands Removal Of Maus From Digital Library Because The Book Is Popular Again

“We’ve said it over and over again, if libraries did not exist today, there is no way publishers would allow them to come into existence. We know this, in part, because of their attempts to stop libraries from lending ebooks, and to price ebooks at ridiculous markups to discourage libraries, and their outright claims that libraries are unfair competition. And we won’t even touch on their lawsuit over digital libraries.

Anyway, in other book news, you may have heard recently about how a Tennessee school board banned Art Spiegelman’s classic graphic novel about the Holocaust, Maus, from being taught in an eighth-grade English class. Some people called this a ban, while others said the book is still available, so it’s not a “ban.” To me, I think school boards are not the teachers, and the teachers should be able to come up with their own curriculum, as they know best what will educate their students. Also, Maus is a fantastic book, and the claim that it was banned because of “rough, objectionable language” and nudity is utter nonsense.

Either way, Maus is now back atop various best seller lists, as the controversy has driven sales. Spiegelman is giving fun interviews again where he says things like “well, who’s the snowflake now?” And we see op-eds about how the best way get kids not to read books… is to assign it in English class.

But, also, we have publishers getting into the banning business themselves… by trying to capitalize on the sudden new interest in Maus.

Penguin Random House doesn’t want this new interest in Maus to lead to… people taking it out of the library rather than buying a copy. They’re now abusing copyright law to demand the book be removed from the Internet Archive’s lending library, and they flat out admit that they’re doing so for their own bottom line….”