AIB-WEB – Per l’immediato ripristino dell’accesso a Project Gutenberg

From Google’s English:  “The AIB Censorship Observatory considers it extremely serious and worrying that, by order of seizure of the Public Prosecutor’s Office in Rome as part of an investigation into digital piracy, the Guardia di Finanza has blocked access from Italy to the Project Gutenberg ( https://www.gutenberg.org/ ), freely accessible and non-profit portal that since 1971 has collected reproductions of books in the public domain, not subject to copyright.

As everyone knows, Project Gutenberg promotes the widest dissemination and knowledge of the registered cultural memory. For years it has been hosted by large universities that made their servers available, before becoming an autonomous organization, one of the main of this type and inspiring model for many other similar ones (such as the Manutius Project in Italy), mainly supported by work. of many volunteers.

We reiterate that it is one of the most qualified projects on the net, with a large amount of documents accessible for free in compliance with the US Copyright Act, because it is in the USA that it is based: they are works in the public domain, out of rights because they have always been public domain (such as the Bible) or because the maximum terms of duration of copyright have passed….”

Italian Public Prosecutor Says Project Gutenberg’s Collection Of Public Domain Books Must Be Blocked For Copyright Infringement | Techdirt

“Back in 2013, we made clear our concerns with the Italian communications watchdog AGCOM setting up new administrative copyright enforcement powers that would allow them to simply up and declare sites to be infringing, at which point ISPs would be ordered to block websites. Soon after that Italy’s public prosecutor seemed to decided that part of his job was also to order websites blocked based solely on the public prosecutor’s say so.

In the latest such order from the Public Prosecutor’s office declaring a list of sites to be infringing, apparently Italy has decided that the famous and wonderful Project Gutenberg website, which is a repository of public domain books, must be blocked. I don’t know about the other 27 sites listed in the order, but Project Gutenberg is no piracy site. Yet here it is ….”

Missing clinical trial data: the knowledge gap in the safety of potential COVID-19 drugs | medRxiv

Abstract:  Abstract Objectives: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of clinical trial results on public registries or through academic publication. We aimed to analyse the knowledge gap in safety data by quantifying the number of missing clinical trial results for drugs potentially being repurposed for COVID-19. Design: ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched using the NCT number to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. Results: Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. 1172 (31.2%) completed trials had tabular results on ClinicalTrials.gov. A further 1066 (28.4%) completed trials had results from the literature search, but did not report results on ClinicalTrials.gov. Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). Conclusion: There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause a large burden of additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.

 

Scandinavian universities perform dismally at reporting clinical trial results

“Universities across Finland, Norway and Sweden have failed to upload the results of hundreds of clinical trials onto the EU Clinical Trial Register, in violation of EU transparency rules….”

Could a patent get in between you and a Covid-19 test? Yes | Opinion | The Guardian

“Imagine if one company held a patent covering all methods of testing for Covid-19 antibodies. The company could charge monopoly prices for its tests and prohibit competitors – including non-profit and university labs – from manufacturing or administering their own. If the company made itself the country’s sole supplier, it would struggle to meet demand. The company would profit, but Americans would face waiting lists, confusion and inequitable access – and the virus would keep spreading.

Would a patent holder ever exploit an outbreak of life-threatening infectious disease in this way? Yes. In 2001, the United States faced a credible threat of an anthrax outbreak, yet Bayer refused to license its patents on ciprofloxacin (Cipro), the most effective antibiotic treatment for anthrax, to competitors, even as Bayer itself struggled to supply the nation’s antibiotic stockpile.

It may seem outlandish to imagine one patent creating a wide-ranging monopoly on diagnostic testing, but it happened. In the 1990s and 2000s, biotech companies obtained and enforced broad patents on medical diagnostics that gave them near-total control of testing for particular conditions. One company obtained patents on methods of diagnosing people at high risk of developing breast cancer and “attempted to eliminate … testing at competing laboratories by sending cease-and-desist letters”; another became “the sole provider of genetic testing for many neurological and endocrine conditions”, including muscular dystrophy and Alzheimer’s disease….”

IP Scholars File Comments with OSTP on Public Access to Scholarly Publications – Center for the Protection of Intellectual Property

“A group of intellectual property scholars filed comments yesterday with the Office of Science and Technology Policy (OSTP), asking it to forgo its plans to make all federally-funded scholarly publications free and open to the public upon initial publication. The comments were submitted in response to a notice of Request for Information (RFI) that was published in the Federal Register seeking recommendations “on approaches for ensuring broad public access to the peer-reviewed scholarly publications, data, and code that result from federally funded scientific research.”

While the RFI did not specifically mention intellectual property rights, it is clear that any proposal to provide free access to federally-funded scholarly publications would have significant ramifications for the copyright owners of those works. The comments argue that any such plan to further lessen the exclusive rights of these owners should be rejected as it “ignores and destroys the resource-intensive review, translation, and commercialization processes required to produce and disseminate these manuscripts” and “confuses the so-called public domain with the public sphere or market.” …”

Respecting Copyright in Time of Crisis | Copyright Alliance

“As access to credible information and quality entertainment has become absolutely essential for both educating ourselves on the pandemic and trying to stay sane through it, understanding how copyright facilitates the creation and distribution of this content is vital. While various organizations suggest rolling back copyright laws or expanding exceptions, it’s clear that these efforts represent an exploitive attempt to do away with a copyright protections that the very same organizations have been trying to undermine for years. In order to keep our sights set on the long-term benefits of copyright and the vast global ecosystems it supports, we must not fall victim to this kind of short-sided opportunism.”

The preprint problem: Unvetted science is fueling COVID-19 misinformation | Ars Technica

“A significant difference between COVID-19 and past pandemics—even the 2009 outbreak of H1N1—has been the speed with which information on the disease has spread. Partly, that’s down to social media, as platforms like Twitter have been embraced by scientists and doctors. But another major factor has been the rise of what we call a preprint—an academic research paper that’s posted to a publicly accessible server in advance of it having gone through the traditional process of peer review. When unvetted science that makes bold claims goes straight to the public, that can cause problems, as illustrated by a recent preprint on coronavirus mutations covered by John Timmer earlier today….”

European universities dismal at reporting results of clinical trials

“Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials.

A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary….”

“Clinical Trial Transparency at European Universities: Mapping unreported drug trials

“Obligation to report the results of all trials Failure to report clinical trial results is not a victimless crime. It has substantial negative consequences for patients and public health. Since July 2014, European Union rules have required each and every clinical trial registered on the EU clinical trials registry to post summary results onto the registry within 12 months of trial completion (6 months for paediatric trials). These rules also apply to trials completed before 2014, and apply irrespective of whether a trial’s outcomes have been published in the academic literature. Thus, all of the clinical trials identified in this report as missing summary results are in violation of European Union transparency rules that were designed to protect the interests of patients and taxpayers. Key findings Overall, 778 clinical trials run by 30 European universities (83% of due trials) are verifiably missing results on the European trial registry, in violation of EU transparency rules. Excluding UK universities, reporting rates are just 7%. The actual figure of due trials missing results is likely to be far higher. ? Only three universities perform well: University of Oxford, University College London, and King’s College London. These universities have already posted over 80% of their trial results. ? Fourteen universities have failed to post a single clinical trial result. This includes all assessed universities in France, Italy, Norway and Sweden. ? The remaining 13 universities also perform weakly, with reporting rates ranging from 2-33%. The fact that UK universities outperform their European peers by a wide margin is due to a combination of pressure from parliament, research funders, and the public. The strong performance by front-runner universities in the UK demonstrates that universities elsewhere in Europe can – and can be expected to – do far better….”