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PDF Editor FAQ

Is US gun confiscation a legitimate risk from gun registration or is it just a “red herring” used to sell guns and inflame gun supporters?

In reading my answer consider that I am a gun owner who campaigned for then-junior-Senator Obama prior to his first term as President (in my capacity then as a Delegate for the California Democratic Party), and who later left the Democratic Party permanently and voted for our current President, who is President Trump. So I have been on both sides of the “major parties” aisle and have voted for both President Obama (for his first term) and for President Trump. While I am hopeful for viable independents not aligned with either major party to be elected to Congress or even make a Presidential bid, I am not holding my breath for this to occur either.Consider the following as an answer:Prior to around 2010, it actually would have been ludicrous to suggest that the Democrats would have included banning the exercise of a Constitutional right as part of their political platform. In fact, popularized Democratic propaganda, including 30 second issue videos which came from the Obama campaign in 2007 prior to his being determined to be the candidate, cited defense of rights as an important issue. Due process, closing Guantanamo, and other rights were (initially) defended by the Presidential candidate (Obama), and keep in mind that Heller hadn't even been decided yet when Obama first was making a bid for office. District of Columbia v. Heller, 554 U.S. 570, would not be decided until June 2008. Obama was not inaugurated until Jan. 2009. The Assault Weapons Ban had expired in 2004, several years before the 2008 Presidential election and before the Heller decision, and would not be renewed. (The AWB was poor and unconstitutional law, despite the rejected legal challenges at the time — had it been brought before today's U.S. Supreme Court upon challenge, it would have been unlikely to survive -- and allowing it to expire was logical.)At this point (in 2008) the Democratic Party was very different than today (now early 2019): in 2008, there were not large numbers of people within the Democratic Party calling out for bans and making seizure of property and denial of rights a platform issue. The anti-rights rhetoric of Feinstein and elements of the California Legislature hadn't truly metastasized or mainstreamed yet. The Democratic Party nationally hadn't yet resorted to open calls for violence, “resistance,” and rejection of any form of Constitutional rights. That was to occur later — by 2010, the Democratic Party had turned formally and irrevocably against the U.S. Constitution, in much the same way it had in the 1860s during the Civil War.June 28, 2010: McDonald vs. City of Chicago was decided. Wikipedia summary: McDonald v. Chicago, 561 U.S. 742 (2010), is a landmark decision of the Supreme Court of the United States that found that the right of an individual to "keep and bear arms," as protected under the Second Amendment, is incorporated by the Due Process Clause of the Fourteenth Amendment against the states. The decision cleared up the uncertainty left in the wake of District of Columbia v. Heller as to the scope of gun rights in regard to the states.California’s Legislature reacted, angrily attempting to claim it was above the U.S. Constitution and decisions of the U.S. Supreme Court. By Jan. 2012, any form of open carry was illegal under State law in California. By 2013, AB48 (10 round mag limit law) had become law in California. From October 2013 through October 2014, 20 gun control bills in California ended up getting signed into law (by the State alone, not counting any local laws), leading many people without recourse except to challenge the state in the courts or hope that the laws would be overturned by organizations that take legal action to defend the 2nd amendment. But even more were to come in 2014 — and this was before the Gunpocalypse laws of 2016 were proposed and became law in California. A full-fledged assault on Constitutional rights was underway in California. In California, any gun owner — no matter whether they have complied or not with California's bans, registration laws, and other unconstitutional laws -- is always under active threat from the State, and should keep legal counsel's number handy on a card in your wallet, as the State is always attempting to remove your ability to exercise a Constitutional right to “keep and bear” arms, that is, your property. If you are a gun owner in California and you do not have legal counsel you can call, change that now or get legal insurance to cover such situations at minimum.November 8, 2016. President Trump was elected. In the days after the election (in mid-November) it was announced by the CPRA, NRA, FPC / FPF, and a variety of other groups that they would soon be suing the State of California to overturn not just Prop 63 (which was passed as a result of voters' actions) but as well, to overturn the various anti-2A bills signed into law in July 2016. These court cases are in different stages today; the cases are still underway — the roster case (which many have speculated about and discussed) against California, is being advanced to the U.S. Supreme Court as of 2019. Even an open carry case against California's carry ban may be heard by the U.S. Supreme Court in 2019. The “new left” — the socialists who took over the Democratic Party — now are predictably and as usual, claiming that California is somehow exempt from U.S. Supreme Court rulings. (They are wrong, but their public position was predictable.) Their anti-rights mania has at this point reached a fever pitch.U.S. Supreme Court confirmations: Gorsuch was confirmed, and took the oath on April 10, 2017. Kavanaugh was confirmed, and took the oath on October 6, 2018. In November 2018, medical care of Justice Ginsburg led to speculation and fear by Democrats that she may pass away before President Trump leaves office; these fears were further amplified as it became apparent the Democratic Party had no-one who would be likely to beat President Trump in 2020, at least based on early polling on public perception of the likeliest Presidential candidates. The pro-gun cases that previously would never have seen the light of day at the U.S. Supreme Court now have a chance (in 2019 or 2020) at being taken up and considered.A divided Congress means as of Jan. 3, 2019, the Democratic-led House can pass whatever it wants, but any gun control measure passed in the House would have to get past the Senate, which is controlled not only by Republicans but by a Turtle who couldn't even get H.R. 38 (Concealed Carry Reciprocity) floor time in the Senate despite it being overwhelmingly passed in the House. The only way Democrats can pass their desired bans now (apart from State laws like California's which are being challenged in the courts) are by trying to get some sort of ban language into a must pass bill, but that tactic means anti-2A provisions can be stripped out in conference committee, by the U.S. Senate, or failing that, can be vetoed by the U.S. President. Let us suppose some anti-2A language is passed by House and Senate in 2019 and escapes veto. The lawyers then challenge it in the courts. Checks and balances.In California, as the best example, registration is designed to facilitate later bans and confiscation. This is part of why California's laws are being challenged in court.Reference / related answer:a. Colin Gallagher's answer to How many California state gun control bills were passed and signed into law from January 2000 through September 2017, and how many more have been passed by the end of September 2018?

What are some ways to encourage pharmaceutical companies to share their data? Who will be the key stakeholders involved and what roles do they play?

'What are some ways to encourage pharmaceutical companies to share their data? Who will be the key stakeholders involved and what roles do they play?'Why is clinical trial data transparency and sharing important? Regulators use this data to approve new drugs and only relatively recently has the general public become aware of the extent to which such decisions hinge on handpicked data sets while an unknown amount remain unpublished, in both clinical trial registries as well as in peer-reviewed scientific journals. If a drug's approved based on part, not all, of the data on it, how could we be sure it's as effective and safe as claimed?This answer addresses the roles, responsibilities and incentives of both academia and biopharma since both are involved in the discussion on clinical trial data sharing and data transparency. Key stakeholders in clinical trial data include both decision makers as well as hapless participants who still aren't part of the decision making process.Decision makers are regulators, scientists, academia, biopharma and science publishing, all of whom have in recent years fostered the notion through regulations and abundant posturing that the entire biomedical research ecosystem from individual investigators on to entities that fund and publish their research is in favor of data transparency and keen to share clinical trial data with peers, partners and maybe even the general public (1).Unfortunately, studies continue to find that a substantial portion of data from completed clinical trials never see the light of day (2, 3). Such analyses also show the rule-makers themselves to be big-time rule-breakers.IMO understanding the main obstacles that prevent clinical trial data sharing from becoming the norm helps understand the kind of policy prescriptions necessary to bring about change.Perverse incentives and absence of tangible incentives for data sharing keep scientists chained to a hyper-competitive, publish-or-perish, winner take all attitude to the scientific data they generate. Their promotions, tenures and grants are decided by their publication, not their data sharing, record (4).Regulators (FDA, EMA, etc.), employers (research institutions, universities) and funders (governments, foundations, academia, industry) remain stubbornly blind to how data sharing remains antithetical to what it takes to forge a successful scientific career.In a scientific culture that prizes originality and novelty above all, scientists currently do not benefit from sharing their data or by mining other people's data to glean new insights simply because funders, journals and employers presently do not similarly reward them as they do those who publish original and novel data generated from their own studies.Total data transparency weakens incentive for drug repurposing, Drug repositioning - Wikipedia, which has increasingly become a lifeline that sustains biopharma revenue in an age where new products have become increasingly expensive and time-consuming to roll out (5, 6).Proposed regulatory solutions fail to adequately address need to protect trade secrets and proprietary information, and do not provide requisite relief and mitigation. Rather, they ignore the real constraints that both academia and biopharma face today and instead exhort them to share data by paternalistically highlighting obligations to volunteer participants. Ignoring such real constraints might instead serve to foster a backlash in the form of inventive expansions of what actually constitute trade secrets and proprietary information, a reaction that would end up helping no one.A systematic review found 85 opinion pieces on the importance of developing incentives for researchers to share their data but fewer studies, 76, that actually tested approaches to increase data sharing (7). Most of the approaches tested entailed mere tinkering around the edges and nothing substantive.Clearly, a substantial gap exists between stated intent and actual actions. Data sharing needs to become part of clinical trial design and a critical aspect for scientific career progression (1). Typically, researchers plan a study with the intention of analyzing the data and publishing a peer-reviewed report upon completion. No thought is given to how the data will be stored such that it's easy to share so others can re-analyze it and neither is data sharing deemed merit-worthy for a scientist's career progression.Clinical trial participants are MIA in these discussions. No clinical trial participants, no clinical trial, no results, no new drugs. As simple as that. Given they're so central to this issue, why are trial participants nowhere to be seen or heard in this debate (8)?Paternalism continues to dominate the biomedicine culture but the general public's passivity and apathy makes it equally culpable.In recent decades, patient and disease advocacy groups have started notching impressive wins and gained accelerated access to new therapies, HIV/AIDS and cancer being cases in point. However, the weakness inherent to the tactics these groups have used thus far is to focus not on the totality but rather narrowly only on enhancing the speed of the drug approval process. Doing so ended up with regulators and drugmakers both cutting corners in the decision making process whereas fighting to get a seat at the table through legislative and regulatory means would have had a far more consequential and beneficial effect with respect to data sharing and transparency.Rest of this answer detailsA recap of regulations mandating clinical trial data be reported and published.Efforts to change the status quo by Ben Goldacre - Wikipedia, the reigning enfant terrible in the clinical trial space, and his collaborative initiative, AllTrials - Wikipedia.Quick recap of recent regulatory developments in the US clinical trial space as well as important global players1997: Food and Drug Administration Modernization Act of 1997 - Wikipedia is passed. The FDAMA led to the creation of ClinicalTrials.gov - Wikipedia, currently the world’s largest online clinical trial registry.2000: ClinicalTrials.gov - Wikipedia comes online, maintained by United States National Library of Medicine - Wikipedia (NLM), a permanent institute within the US NIH.2007: Food and Drug Administration Amendments Act of 2007 - Wikipedia is passed. The FDAAA mandates the following (9),All applicable clinical trials to be prospectively registered at ClinicalTrials.gov - Wikipedia.Data should include information on study participants, summary outcomes, particularly adverse events.Mandatory publication of trial results upon completion.Section 801 of FDAAA establishes penalties for non-compliance. For example, US $10000 per day if trial results not posted within 12 months of completion.Applicable trials entail those other than Phase I and with at least one study site in the US.Limitations of FDAAA that end up excluding data on vast majority of treatments in use today,Excludes clinical trial results obtained pre-2007.Only requires publication of trials completed after 2008.Not to mention strikingly unenforced.In response to poor compliance with these reporting requirements, US regulators tightened perceived ambiguity and issued what is called the Final Rule in September 2016 (10).Also note that the US FDA has dismantled patient protections with regard to international clinical trials. Declaration of Helsinki - Wikipedia is the international code of medical ethics which stresses that everyone involved in a clinical trial has a duty to make the findings public. Specifically, in 2009 after years of insisting that companies applying for marketing authorization for a drug in the US needed to provide evidence that all foreign trials had been compliant with the Helsinki declaration, the FDA diluted its position by pegging such trials to the much lower standard of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines (11). As Goldacre points out,These guidelines are only voted on by members of the EU, USA and Japan.They are more focused on procedures while Helsinki focuses on moral principles.Over the years, GCP has become the main ethical regulation of trials in the developing world, a sign of expediency trumping Informed consent - Wikipedia.This kind of thinking is penny-wise, pound-foolish since no matter the experimental drugs in question get initially tested on non-US populations, once approved in the US, they'd be consumed by Americans, no?The WHO. Mainly soft not hard power. On May 18, 2017, major research funders across the world, now numbering 21, released a statement on the WHO International Clinical Trials Registry Platform pledging to implement self-avowed policies and impose audits to ensure trials they fund are reported (12). US regulators notably MIA in this statement. As the global public health organization of record, the WHO has substantial soft power it could bring to bear in mediating or nudging organizations that fail to measure up during periodic audits.The ICMJE (International Committee of Medical Journal Editors): ICMJE recommendations - Wikipedia. It announced in 2005 that (see below from 13),'The ICMJE member journals will require, as a condition of consideration for publication, registration in a public trials registry. Trials must register at or before the onset of patient enrollment. This policy applies to any clinical trial starting enrollment after July 1, 2005. For trials that began enrollment before this date, the ICMJE member journals will require registration by September 13, 2005, before considering the trial for publication.'With 16 journal members In 2017, up from 11 in 2004, ~3300 journals now reportedly follow ICMJE recommendations. To neutralize a perceived barrier to publication, ICMJE allows trial results to be posted to clinical trial registries (14, 15).Ben Goldacre - Wikipedia & The AllTrials EffortA physician by training who morphed into a journalist, writer and activist, Ben Goldacre is well-known in his native Britain for his two polemics, Bad Science (book) - Wikipedia and Bad Pharma - Wikipedia. His energizer bunny-like advocacy wedded to a keen sense of the fierce urgency of now makes him a compelling figure while his writing, though often hyperbolic, manages to remain engaging even when analyzing hard science or posting trenchant criticisms of prevailing policies and pervasive conflicts of interests among the deciders in the clinical trial space.Through the collaborative launch of AllTrials, Goldacre is expending yeoman effort to upend the inimical status quo of cherry-picked clinical trial data often serving as the basis for new drug approval, leaving the rest hidden and unpublished.Unlike the FDAAA, AllTrials calls for registration and publication of all clinical trials on all treatments in current use. AllTrials' definition of publication includes full reporting of methods as well as publication of negative data.As of December 2017, a total of 735 organizations from all over the world have joined AllTrials while 91006 people have signed the AllTrials petition (16). On the one hand, this seems promising.OTOH, 622 organizations and 87956 petitioners as of 24 April, 2016 (see page 7 of 17) means over 20 months, 113 organizations but only 3050 additional individuals signed a petition supporting this initiative.Clearly, there's a sharp contrast between institutional and individual participation in the AllTrials effort. Such an anemic individual participation rate only underscores how passive and apathetic even patients and disease advocacy groups remain about one of the most critical aspects of biomedicine, namely, transparency of clinical trial data.Bibliography1. https://www.ncbi.nlm.nih.gov/books/NBK269030/pdf/Bookshelf_NBK269030.pdf2. Tirumalai Kamala's answer to Why are some clinical trials finished, but the results not reported?3. Tirumalai Kamala's answer to Why are some clinical trials finished, but the results not reported?4. Friesike, Sascha, and Thomas Schildhauer. "Open science: many good resolutions, very few incentives, yet." Incentives and Performance. Springer International Publishing, 2015. 277-289.5. Brassington, Iain. "The ethics of reporting all the results of clinical trials." British medical bulletin 121.1 (2017): 19-29. ethics of reporting all the results of clinical trials | British Medical Bulletin | Oxford Academic6. Baghai, Tabassom. "Lack of clinical trial data transparency and current solutions." University of Ottawa Journal of Medicine 7.1 (2017). https://ottawa.scholarsportal.info/ojs/index.php/uojm-jmuo/article/download/2021/18617. Rowhani-Farid, Anisa, Michelle Allen, and Adrian G. Barnett. "What incentives increase data sharing in health and medical research? A systematic review." Research Integrity and Peer Review 2.1 (2017): 4. https://researchintegrityjournal.biomedcentral.com/track/pdf/10.1186/s41073-017-0028-9?site=researchintegrityjournal.biomedcentral.com8. Haug, Charlotte J. "Whose Data Are They Anyway? Can a Patient Perspective Advance the Data-Sharing Debate?." New England Journal of Medicine 376.23 (2017): 2203-2205. http://www.nejm.org/doi/pdf/10.1056/NEJMp17044859. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm10. National Institutes of Health. "Clinical Trials Registration and Results Information Submission. Final rule." Federal register 81.183 (2016): 64981. https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdf11. https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf12. http://www.who.int/ictrp/results/ICTRP_JointStatement_2017.pdf13. De Angelis, Catherine, et al. "Clinical trial registration: a statement from the International Committee of Medical Journal Editors." (2004): 1250-1251. http://www.nejm.org/doi/pdf/10.1056/NEJMe04822514. http://icmje.org/icmje-recommendations.pdf15. Dal‐Ré, Rafael. "The ICMJE trial data sharing requirement and participant's consent." European journal of clinical investigation (2016).16. Supporters17. Breil, Thomas, et al. "An Assessment of Publication Status of Pediatric Liver Transplantation Studies." PloS one 11.12 (2016): e0168251. http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0168251&type=printableThanks for the R2A, Jeffrey Brender.

I am an unmarried Singaporean mother giving birth overseas (Johor, Malaysia), can I apply for citizenship by descent for my child as a single mother?

A2A. Although you’re creating an unnecessary situation considering that Johor is so near to Singapore, but that’s besides the point here. You are also mistaken that you will also required to be married on the ICA website. Having said that, your child should technically qualify to be a Singapore Citizen by descent automatically;From the following URL; Constitution of the Republic of SingaporeStatus of citizen of Singapore120.—(1) There shall be a status known as citizen of Singapore.(2) The status of a citizen of Singapore may be acquired —(a) by birth;(b) by descent;(c) by registration or, before the commencement of this Constitution, by enrolment; or(d) by naturalisation.Citizenship by birth121.—(1) Subject to this Article, every person born in Singapore after 16th September 1963 shall be a citizen of Singapore by birth.(2) A person shall not be a citizen of Singapore by virtue of clause (1) if at the time of his birth —(a) his father, not being a citizen of Singapore, possessed such immunity from suit and legal process as is accorded to an envoy of a sovereign power accredited to the President;(b) his father was an enemy alien and the birth occurred in a place then under the occupation of the enemy; or(c) neither of his parents was a citizen of Singapore.(3) Notwithstanding clause (2)(c), the Government may, where it considers it just and fair and having regard to all the circumstances prevailing at the time of the application, confer citizenship upon a person born in Singapore.Citizenship by descent122.—(1) Subject to clauses (2) and (3), a person born outside Singapore after 16th September 1963 shall be a citizen of Singapore by descent if, at the time of his birth —(a) where the person is born before the date of commencement of section 7 of the Constitution of the Republic of Singapore (Amendment) Act 2004, his father is a citizen of Singapore, by birth or registration; and(b) where the person is born on or after the date of commencement of section 7 of the Constitution of the Republic of Singapore (Amendment) Act 2004, either his father or mother is a citizen of Singapore, by birth, registration or descent.(2) A person born outside Singapore shall not be a citizen of Singapore by descent by virtue of clause (1) unless —(a) his birth is registered in the prescribed manner at the Registry of Citizens or at a diplomatic or consular mission of Singapore within one year, or such longer period as the Government permits, after its occurrence; and(b) he would not acquire the citizenship of the country in which he was born by reason of his birth in that country where —(i) in the case of a person born before the date of commencement of section 7 of the Constitution of the Republic of Singapore (Amendment) Act 2004, his father is a citizen of Singapore by registration at the time of his birth; or(ii) in the case of a person born on or after the date of commencement of section 7 of the Constitution of the Republic of Singapore (Amendment) Act 2004, either his father or mother is a citizen of Singapore by registration at the time of his birth.(3) Without prejudice to clause (2), a person born outside Singapore of a father or mother who is a citizen by descent at the time of his birth shall not be a citizen of Singapore by descent by virtue of clause (1) unless the parent who is the citizen by descent has lawfully resided in Singapore —(a) for a period of, or for periods amounting in the aggregate to, not less than 5 years before that person’s birth; or(b) for a period of, or for periods amounting in the aggregate to, not less than 2 years during the period of 5 years immediately preceding that person’s birth.(4) A person who, being a minor, becomes a citizen of Singapore by descent shall cease to be a citizen of Singapore on attaining the age of 22 years unless within 12 months after he attains the age of 21 years he takes the Oath of Renunciation, Allegiance and Loyalty in the form set out in the Second Schedule and where the Government so requires divests himself of any foreign citizenship or nationality.Considering that both the father and mother are Singaporeans, the safest way is to ensure that both the dad and mom’s name is within the birth certificate, so this will allow you to process the citizenship by descent relatively cleanly.However, you’re going face some serious challenges. From the moment your child is born, he/she might effectively be stateless. The Malaysian citizenship law states that kids who are stateless will be granted Malaysian Citizenship, but in your case, its not so clear considering he/she is entitled to SG Citizenship.During this period of time, you’ll need to apply for the SG Citizenship for your child. This can take anytime from 1 month to 6 months. After that, you’ll need to get the passport BEFORE you can travel. Prior to that, your child might effectively have no identity in Malaysia. Things like vacinnation, doctor visits can, and might become unnecessarily complicated.Application of the SG Citizenship also isn’t exactly a walk in the park. You need to submit plenty of documents to the relevant authorities. Assuming the father isn’t in the birth certificate, he cannot apply. The mother must. In that case, you can’t do it in Singapore because you have no way to return to Singapore with the Child.There is a Singapore consulate in JB City Square, but I’m not sure what are the services they provide. If they can’t provide you with the relevant assistance, you need to drive/bus/fly to KL to get this done, unless of course, you leave your child with someone and you come to ICA to submit the documents.Personally, I don’t know what your personal reasons are, but I’m pretty sure that there are better ways to do what you want to do, as opposed to giving birth in JB. It’s just a unnecessary distraction and complication which does not add any value to me.

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