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The Supreme Court decision to strike down a Louisiana law on June 29 that would have restricted access to abortion in the state was broadly seen as a win for the reproductive rights movement. Some scholars and activists caution, however, that the narrow decision does not necessarily signal abortion rights will be protected by the high court in future cases.

In a surprise 5-4 decision, the conservative Chief Justice John Roberts joined liberal justices in striking down the law, which would have required abortion providers in Louisiana to have admitting privileges to a hospital within 30 miles. If upheld, the law could have shut down all but one abortion clinic in the state.

WATCH: What Supreme Court decision on Louisiana law means for U.S. abortion rights

I was sort of bracing for a defeat for the abortion providers, so in some respect, I was pleasantly surprised by Roberts joining the liberal justices in the decision, said Melissa Murray, an NYU law professor specializing in family law, constitutional law, reproductive rights and justice. But, she warned, I think its a much more muted victory than many perhaps appreciate. The chief justice is very clear that his views on abortion havent changed.

When Roberts served as an attorney in two consecutive Republican administrations those of Presidents Ronald Reagan and George H.W. Bush he helped author briefs arguing that Roe v. Wade, the landmark case that legalized abortion nationwide, was wrongly decided and should be overturned. But in his Senate confirmation hearing in 2005, he agreed that the case was settled law and said he would err toward respecting precedent.

Heres a look at the implications of the June 29 decision on June Medical Services LLC. v. Russo, and what it means for abortion rights and access in the U.S. going forward.

The Louisiana law blocked last week was the second so-called TRAP law or Targeted Regulation Against Abortion Providers to make its way to the Supreme Court within the last five years.

It was the first time an abortion case was heard since President Donald Trump filled the high courts vacancies by appointing two conservative justices, Brett Kavanaugh and Neil Gorsuch.

In reinstating the Casey standard, hes gutted Whole Womans Health. Were back to 1992.

The legal argument that TRAP laws hinge on is the idea that abortion is in some ways bad for women, according to Mary Ziegler, a law professor at Florida State University specializing in the legal history of reproduction and author of Abortion in America: A Legal History from Roe to the Present.

Ziegler said the idea behind these laws is that if abortion clinics have more stringent requirements, women will have better continuity of care. Its part of this general argument that abortion, and abortion providers, are unsafe, she said when speaking with the PBS NewsHour in February.

Kathaleen Pittman, a clinic administrator at Hope Medical Group in Louisiana and a plaintiff in the the Supreme Court case, told the NewsHour in March that the state had tried everything to decimate access to abortion care.

The situation here is already dire and this law would be the last straw for most of the remaining clinics. Were hopeful that the court will recognize how devastating this law would be for women in our state, Pittman said in March.

The Supreme Court did end up siding with the health clinic, largely because it had already ruled back in 2016 that a similar Texas rule requiring abortion providers to have hospital admitting privileges placed a substantial obstacle in the path of women seeking an abortion, constituting an undue burden on abortion access.

Citing this precedent set in the 2016 case, Whole Womans Health v. Hellerstedt, Chief Justice Roberts sided with the liberal justices in blocking the Louisiana regulation from taking effect, even though he had ruled against the Texas law while on the high court in 2016.

I joined the dissent in Whole Womans Health and continue to believe that the case was wrongly decided, Roberts wrote, citing the Texas law that was struck down in 2016. The question today however is not whether Whole Womans Health was right or wrong, but whether to adhere to it in deciding the present case.

Abortion opponents protested the Supreme Courts decision. Kristen Waggoner, the general counsel and SVP of the Alliance Defending Freedom, which signed an amicus brief in support of the Louisiana law, likened reproductive rights advocates argument that hospital admitting privileges actually endanger women to the fox guarding the hen house.

Were going to hold abortion to the same standard that we hold other doctors, Waggoner told the NewsHour. And I think the standard should be applied to protect women no matter where their feelings are on the abortion issue itself.

Louisianas Solicitor General, Elizabeth Murrill, who defended the law before the Supreme Court, also said that clinics such as the ones targeted in the June Medical Services case actually endanger womens health. Here we have a history of egregious health and safety violations by the clinics and by the doctors who work there, Murrill said in an interview with the NewsHour when the Supreme Court heard arguments for the case in March. She added that abortion providers had a vested interest in being less regulated and having less oversight.

While complications do arise from abortion in the U.S., severe consequences, such as death, are rare. A report released by the non-partisan National Academies of Sciences, Engineering and Medicine in 2018 found that abortion is largely a safe procedure. It noted, though, that TRAP laws and other regulations instituted by states such as waiting periods and pre-abortion ultrasounds can complicate and delay the procedure, making it less safe.

Even though another law targeting abortion has been struck down by the court for now, NYU Laws Murray cautioned that the narrow nature of Roberts opinion could actually galvanize anti-abortion activists to pursue more restrictive laws in the future. This is because he cited another 1992 abortion case, Casey v. Planned Parenthood, in his reasoning.

Murray noted that while the Casey decision affirmed the right to an abortion, it also lowered the standards by which courts review abortion legislation, and allowed states to put in place regulations to further the health or safety of a woman seeking an abortion, as long they do not impose an undue burden on a womans ability to obtain the procedure.

While the decision was a nominal victory for the anti-abortion side, Murray said it actually empowered states to continue restricting access to the procedure. She worries the same could happen following the June v. Russo decision.

In his opinion, Roberts wrote, the only question for a court is whether a law has the effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus. He encouraged courts not to weigh the specific benefits against the burdens of abortion laws, as the 2016 Supreme Court decision on the Texas law did, but rather to simply decide whether the proposed legislation poses an obstacle to women who are seeking abortions.

Murray called this a more amorphous standard. In reinstating the Casey standard, hes gutted Whole Womans Health, she said. Were back to 1992. And I think what you will see is states empowered to continue restricting access, and courts no longer tethered to weighing benefits against the burdens of abortion laws like the Louisiana one, she added.

The ADFs Waggoner, though, said she saw Roberts line of decision-making as a positive step for the anti-abortion movement, as it may allow states to regulate abortion providers in a way that protects women as long as theres a reasonable relation to a legitimate state interest.

While one Louisiana abortion restriction has been settled for now, the issue is by no means going away. There are some 15 abortion cases that are just one step away from making it to the Supreme Court, according to Planned Parenthood. While some of the restrictions in question are similar to the Louisiana law, many others ban abortion at various points in pregnancy, or on the basis of disability. Others ban specific types of abortion, such as dialation and evacuation.

These laws are part of a broader strategy by the anti-abortion movement to pursue a patchwork of legislation that gradually chips away at abortion access in the hopes of eventually overturning Roe v. Wade.

As of July 1, 22 states had banned abortion between 13 and 24 weeks from a womans last menstrual period, according to the Guttmacher Institute, a research institution that advocates for abortion rights. Three states Alabama, Louisiana and Utah had attempted to ban abortion at any point in a pregnancy, but those bills were blocked by the courts.

In mid-June, Tennessee lawmakers passed a bill that would ban abortions after a fetal heartbeat is detected, as early as six weeks into a pregnancy. The Iowa legislature passed a bill that same week that would require women to wait 24 hours before receiving an abortion, and Mississippi Governor Tate Reeves signed a law banning abortion based on race, sex or genetic issues on July 1.

Some states more recently tried to limit abortions due to the COVID-19 pandemic, with Texas, for example, declaring that abortion doesnt qualify as an essential surgery. While those bans are no longer in play today they have been blocked by the courts some could return as states respond to another spike in coronavirus cases.

The Guttmacher Institutes state policy director, Elizabeth Nash, said that she would not be surprised to see states emboldened by the June Medical Services decision pursuing more restrictions similar to the Louisiana law, with the thinking that the courts will be less stringent in weighing the benefits against the burdens of such requirements.

Abortion opponents read these cases very carefully and amend their strategy based on the rulings, Nash told the PBS Newshour. It would not surprise me to see abortion restrictions next year that look to these kind of restrictions. You may see states that have, say, counseling and waiting period laws look to make them more burdensome in some way.

Laws targeting abortion providers have affected access to clinics over the past decade. Between 2011 and 2017 the number of abortion clinics in the U.S. dropped by almost 4 percent, but states in the South were more heavily impacted, with a net decline of 50 clinics 25 in Texas alone. The Midwest lost a net 33 clinics in the same time period. Both regions had the largest share of new abortion restrictions in the country.

Catherine Glenn Foster, the president & CEO of Americans United Life, argued in an interview with the Newshour last fall that disparities in access are tied to the fact that abortion is a profit-making venture: There are large parts of the country that dont have a lot of people, and those are places where there arent many abortion facilities, but thats a business decision. She said she couldnt think of anything less feminist than the sentiment that we cant have an education, career, plan for families without legalized abortion.

But reproductive rights organizations view the issue differently, and already see state-level challenges to abortion as a blow to the reproductive rights movement.

The likelihood of the Supreme Court going out of its way this year to overrule Roe vs. Wade is fairly low, but it can do the exact same thing in terms of an actual persons ability to access abortion by making it harder and harder or impossible to challenge these laws, Andrew Beck, a senior staff attorney for the Reproductive Freedom Project at American Civil Liberties Union, told the NewsHour.

Guttmachers Nash said the increasingly conservative makeup of the Supreme Court could pose a serious challenge to abortion access in the coming years.

There is a real palpable threat to abortion rights at the Supreme Court, said Nash. Its clear from Roberts opinion that he would support abortion restrictions.

Courtney Norris contributed reporting to this story.

Originally posted here:
Whats next for abortion legislation in the U.S.? - PBS NewsHour

By Shannon Ebrahim 16h ago

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After a week, she is having trouble breathing, but when she goes to the nearest hospital, there is a shortage of medical staff to process her admission as many have succumbed to the virus due to a lack of PPE (personal protective equipment). There are also no ventilators to assist her to breathe.

She knows this could spell the end of her life, and there will be no one to take care of the three children she has left alone at home.

This is what happens when the noose of sanctions are tightened on a country in the middle of a global health pandemic - a country that already had a collapsing economy thanks to unilaterally imposed US sanctions.

There are no ethics or conscience when it comes to US enemies, even in the middle of a deadly pandemic. If denying Venezuelans life-saving medicine and equipment might hasten the collapse of the Maduro regime, then the US is all for it.

US allies are too scared to fill the vacuum and deliver the desperately needed aid and assistance to Venezuela, even on a humanitarian basis, due to the threat of secondary sanctions on countries that buck the US economic blockade. It is only countries like China, Russia, and Cuba that have assisted the people of Venezuela in their fight against Covid-19.

Foreign Minister Jorge Arreaza was correct when he said in March that the US illegal and unilateral coercive measures against his country were a form of collective punishment.

Under the 1949 Geneva Convention, collective punishment is a war crime and a crime against humanity as defined by the UN International Law Commission. When countries refuse to send medicine and supplies to Venezuela in the middle of a global health pandemic due to the unilateral US sanctions regime, they too are complicit in a war crime.

The US has laid down the gauntlet - any firm that trades with Venezuelas public sector could face secondary sanctions.

But the health infrastructure in Venezuela is run by the state, which has made it virtually impossible to access medical equipment, supplies, Covid-19 testing kits and medicine.

Since the outbreak of the pandemic, airlines and shipping companies have been too afraid to go to Venezuela to deliver essential goods exported from countries that refuse to be cowed by US bully tactics.

As a result, Venezuelans are dying, and the US is under the misguided notion that this will put an end to the great Bolivarian revolution, and finally succeed in its regime change agenda - with a little help from Covid-19.

What is that notorious concept: Dont waste a good crisis?

This inhumanity has not escaped condemnation by senior UN officials. The UN High Commissioner for Human Rights, Michelle Bachelet, has called for sanctions to be eased or suspended during the pandemic.

Three UN Special Rapporteurs have called on the US to lift sanctions on Venezuela due to the severe impact on the human rights of its people.

We have to give it to the Americans: they dont even try to hide or nuance their intentions any more - they put them out there for us on a silver platter. In February, US Secretary of State Mike Pompeo told the Munich Conference that the US seeks to oust Maduro.

In March, at the onset of the coronavirus pandemic, the US tightened its sanctions on the country.

US President Donald Trump wasted no time in waving a red flag to a bull by stationing a naval detachment off the coast of Venezuela, to prove that the US is a very real and present danger.

In May, one of the highest- ranking members of the Republican party, Lindsay Graham, penned an article in the Wall Street Journal which said: The US must be willing to intervene in Venezuela the way it did in Grenada.

In 1983, the US had overthrown the legitimate government of Grenada through military intervention.

Graham went even further to say: If measures are not taken then, the US should move military assets to the region.

But such threats form only part of the range of techniques the US uses to undermine foreign governments it does not find palatable to its national interests. Its what is called a hybrid war.

Another favourite tactic is to pressure the International Monetary Fund to deny such governments much needed funds in the context of a suffocating sanctions regime. The US Treasury Department has pressured the IMF to deny Venezuela access to emergency funds to fight the Covid-19 pandemic.

When President Nicolas Maduro wrote to the IMF requesting a $5 billion loan from the Covid-19 emergency fund to strengthen Venezuelas detection and response systems, the request was flatly denied.

Whoever believed the mantra of the Western-controlled international financial institutions, We are all in this together?

What they should have said is, All lives matter as long as you are not Venezuelan, Cuban, Iranian, or North Korean.

* Shannon Ebrahim is the foreign editor of the Independent Media Group.

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No ethics when it comes to US enemies, even in the middle of a deadly pandemic - IOL

Mumbai July 07, 2020 : Institute of Medicine & Law (IML) conducted the 5th National Convention on Medicine & Law on July 05, 2020. This event is an influential and foremost meeting that discusses and deliberates on changes needed in laws relating to healthcare in India.

Session 1 was on Organ Transplant in India Legal Issues and Solutions, and a few prominent problems, issues, and recommendations discussed various issues like - low allocation in the state's budget for health, fear psychosis among doctors, definitions of death in Indian law, coordination between public and private hospitals, need for more hospitals as organ retrieval centres, procedures governing declaration of brain-stem death, etc,

Session 2 was on Legal & Regulatory Framework for Tele-Health The Way Forward and a few prominent problems, issues, and recommendations discussed the need for comprehensive and overarching legislation, apprehensions in minds of doctor and patients, security of data, confidentiality, privacy, commercialization of medicine, acceptance of telemedicine by medical insurance providers & indemnity providers to doctors and hospitals, problem of patients calling at odd hours, not paying fees, data charges of platforms, patients outside India, friendly advice, informal chats, adverse event reporting, bad audio / video, managing data, cyber security, different types of consultations, and so on needs to be clarified.

Dr. T N Ravishankar, ex-President, IMA Tamil Nadu was the convenor of the first session, whereas Dr. Dilip Walke, ex-President, Medico-Legal cell, FOGSI was convenor of the second session. Dr. Parag Rindani, CEO Wokhardt Hospital, Mumbai Central was the moderator of both the sessions.

Dr. Bhagwat Karad, Member of Parliament, Rajya Sabha and himself a paediatric surgeon noted that the convention has involved everybody, viz. doctors, experts in law, patient group, and representation from other countries also.

A doctor has done his job till such time as he has given a reasonable standard of care. As a judge whenever a case would come to me, the scales of justice would always shift in favour of the doctor said Justice Sunil Ambwani, Former Chief Justice of Rajasthan High Court, and also the Chairperson of the e-committee, Supreme Court of India.

The nation today needs a central law on uniform determination of death, even the WHO has recommended, and many countries are following this was one of the key recommendations that was proposed by Mahendrakumar Bajpai, Advocate Supreme Court.

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IML conducts the 5th National Convention on Medicine and Law - ETHealthworld.com

Faculty from the Wayne State University School of Medicine and Wayne State University Law School have teamed to publish a paper this month on legal and ethical issues associated with community detection of COVID-19 through wastewatermonitoring.

Professor of Physiology Jeffrey Ram, Ph.D., and Associate Professor of Law Lance Gable, Ph.D., along with Dr. Rams daughter, University of Maryland Professor of Law Natalie Ram, co-wrote Legal and Ethical Implications of Wastewater SARS-CoV-2 Monitoring for COVID-19 Surveillance, now available in the Journal for Law and Biosciences.

The paper, already a popular download, is listed on the Social Science Research Networks Top Ten download list in several categories.

Dr. Ram also is director of the Wayne State University Belle Isle Aquarium Field Research Laboratory.

Scientists have observed that molecular markers for COVID-19 can be detected in wastewater during an outbreak and, in some cases, before the first case is confirmed, they wrote. The U.S. Centers for Disease Control and Prevention, and other government entities, are considering whether to add community surveillance through wastewater monitoring to assist in tracking disease prevalence and guiding public health responses to the pandemic.

This scientific breakthrough may lead to many useful potential applications for tracking disease, intensifying testing, initiating social distancing or quarantines, and even lifting restrictions once a cessation of infection is detected and confirmed. Yet, new technologies developed in response to a public health crisis may raise difficult legal and ethical questions about how such technologies may impact both the public health and civil liberties of the population, the authors wrote. Even if reliability and efficacy are established, limits on sample and data collection, use and sharing, must also be considered to prevent undermining privacy and autonomy in order to implement these public health strategies consistent with legal and ethical considerations.

The article describes recent scientific evidence regarding COVID-19 detection in wastewater, identifying public health benefits that may result from this breakthrough, and limitations of existing data. It also assesses the legal and ethical implications of implementing policy based on positive sewage signals.

The topic of wastewater epidemiology of COVID-19 is a very new and extremely active one, Dr. Ram said. We (at Wayne State) have assembled a team that includes microbiologists, an epidemiologist, a law professor, medical students, collaborators outside of Wayne State and more.We have support from Healthy Urban Waters.

Healthy Urban Waters is a collaboration of WSU researchers networked with the community to focus on water in an urban setting and future impacts of human culture on community, the ecosystem and economic health.

Dr. Ram and Dr. Gable were invited to present at a new community interaction forum organized with COVID-313 by the WSU Office of theProvosts Social and Behavioral Determinants of Health Steering Committee. They plan additional projects together.

Natalie Ram writes about the legal and ethical uses surrounding various biotechnologies, including the use of DNA by the police. Her decision to pursue the philosophical side of science, including ethics and law, was partly inspired by her Wayne State connections.She was part of a summer science program for girls organized by Wayne State Professor Alvin Saperstein at Wayne State, and while a college student at Princeton she conducted molecular research one summer on pre-implantation genetic diagnosis at WSUs Center for Molecular Medicine and Genetics.

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Wayne Medicine and Wayne Law professors team up to explore legal and ethical issues of wastewater monitoring for COVID-19 - The South End

More than 25,000 people have volunteered so far to be infected with the novel coronavirus through 1DaySooner, an online recruitment organization, as an aid in testing vaccine candidates to prevent Covid-19. These volunteers know that Covid-19 can cause suffering and even death yet they are stepping forward, willing to risk their lives, because some researchers and academics contend that such experiments in humans could accelerate vaccine development.

As a physician and a scientist who has cared for patients and who has been involved in the development of vaccines, I feel the urgency to get a vaccine approved for global use. And I have deep admiration for the courageous volunteers who are willing to put themselves in danger.

In this situation, however, their sacrifice cannot be justified. Volunteers need to be protected from both known and unknown risks. The effort to develop a vaccine should not be jeopardized by this well-intentioned but unnecessary experiment.

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In the context of an ongoing pandemic, the conventional pace of vaccine development frustrates the public, the government, public health experts, vaccine creators, regulators, and others. It is understandable that many are seeking ways to accelerate the demonstration of safety and efficacy of vaccine candidates. The mumps vaccine, considered the fastest vaccine ever developed, took scientists four years to go from collecting viral samples to securing FDA approval in 1967. A decade or longer is more typical. Everyone is hoping that inventing, testing, obtaining approval and producing a Covid-19 vaccine might be on track to set a new record.

The practice of deliberately infecting people with disease, termed human challenge trials, has a long history. It is embedded in the origin of the very first vaccine in 1796, when Edward Jenner, an English physician, purposely infected his gardeners 8-year-old son with cowpox after observing that people previously infected with cowpox, a relatively mild disease, seemed protected from smallpox, one of the deadliest scourges of the time.

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Now, in the midst of the coronavirus pandemic, human challenge studies are being considered again.

In the June 1 issue of the Journal of Infectious Diseases, Nir Eyal, Marc Lipsitch, and Peter G. Smith argue that this approach could accelerate the development and approval of a Covid-19 vaccine by many months. That may sound tempting, but human challenge studies with live virus are unlikely to save time. Moreover, there are ethical and practical reasons for not undertaking human challenge studies with this virus. These authors, like 1DaySooners volunteers, are well-intentioned but wrong.

Those in favor of human challenge trials propose enrolling as subjects only healthy young adults, since the Covid-19 mortality rate in this group is low. Just 7% of all Covid-19-related deaths in the U.S. have occurred among those aged 25 to 54 years, compared to 80% in those over age 65. Yet the example of fatal infections in health care workers in the prime of life makes clear that even healthy non-elderly adults may succumb to the novel coronavirus.

Human challenge studies are generally contemplated only when rescue with a lifesaving treatment or intervention is available should a vaccine candidate not protect a volunteer from the disease. But there is no cure or treatment against the SARS-CoV-2 virus that can be deployed with confidence, making viral challenge particularly risky and ethically questionable.

Most people, likely including most of the volunteers, tend to think of vaccines as fully effective: They either work or dont. This belief generally stems from the success of vaccines for childhood diseases like measles and mumps. But some vaccines, especially those for adults, are much less effective: There are seasons when the flu vaccine is only 70% to 80% effective, or sometimes even less. Imagine, for a moment, that a vaccine candidate undergoing testing turns out to generate immunity in 80% of those who receive it. Then 20% will become infected with Covid-19.

An equally disturbing scenario is what if one of the first volunteers dies, either due to the play of chance, a problem with the vaccine, or the individuals genetic makeup? This is unlikely to happen but it can, and did, in another setting with consequences that stretched far beyond the single tragic death.

In 1999, Jesse Gelsinger volunteered for one of the first gene therapy trials. The 18-year-old had a rare metabolic genetic disorder, but his condition was managed with medication; he was basically healthy. He volunteered for a safety trial of a virus-based gene-therapy and died as a result. Missteps in the trial, and the subsequent controversy surrounding his death, set the field of gene therapy back by at least two decades. That hiatus deprived a generation of patients with genetic disorders of treatments.

With vaccines already a target of widespread misinformation campaigns, the death of a single volunteer would likely cause even greater damage. From a public health perspective, it would be especially disastrous if it both slowed the race to develop a coronavirus vaccine and fueled the anti-vaccination movement.

There are other ethical considerations. An important principle in human challenge studies is that subjects must give their informed consent in order to take part. That means they should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.

Covid-19 was initially thought to be mainly a respiratory ailment. We now know that it can damage the kidneys, circulatory system, and the heart. It was initially believed that children could not be sickened by SARS-CoV-2, but it now appears that dozens have developed a severe inflammatory syndrome. And we know nothing about potential long-term complications of Covid-19 because the disease has only been in humans for months. Taken together, this means that no volunteer is able to give true informed consent.

Given these risks, there might still be some justification for a human challenge trial if we knew for certain it would accelerate the development of an effective vaccine. But safer trials can get us to a vaccine in the same amount of time without taking on additional risk for volunteers, especially now that some vaccine candidates already have entered Phase 2 clinical trials and several others are close behind.

In a conventional trial, subjects are injected with either the experimental vaccine or placebo. They are then monitored to see if those who got the vaccine are less likely to contract the disease while going about their daily lives. In a human challenge study, things can theoretically happen more quickly, since volunteers are deliberately infected after getting the trial vaccine or placebo.

But human challenge trials take time, too. For Covid-19, subjects would likely have to receive two doses of vaccine (spaced by weeks), wait for potential immunity to develop, then be infected with the live virus and observed for weeks to months. Since the challenge trial would need to start small and be expanded only with great caution because of the risks involved, it would take months to deliver sufficient data. Safety data, in particular, would be lacking, even though this is one of the biggest issues confronting a new vaccine, because the size of the trial would be too small to garner robust safety data and data about adverse effects of the vaccine would be confounded by the administration of the live virus.

There is no short cut for determining safety.

A large-scale, conventional study could likely be conducted just as quickly. In addition, monitoring and interim analyses of conventional trials raise the possibility of some kind of conditional or emergency use approval while the trials continue. If that happened, a vaccine might be available for certain high-risk or vulnerable groups in record time, namely 12 to 18 months from laboratory to clinic.

A final issue is that the results of the proposed human challenge studies come exclusively from the experience of younger adults, and cannot be extrapolated to the elderly, who tend to have weaker immune responses and the highest Covid-19 mortality rate. The volunteers might end up having risked their own health without truly helping those who are in greatest need of vaccine protection.

The world is overwhelmed by the pandemic. It is imperative to expedite development and approval pathways without forgoing safety and effectiveness. Ascertaining the risks intrinsic to the disease versus those of a new vaccine in specific populations health care workers, first responders, the elderly, those with comorbidities, and the like is essential. But acceleration should not mean forsaking ethical concerns, putting well-intentioned volunteers at needless risk, or setting back global vaccine efforts.

Michael Rosenblatt, M.D., is the chief medical officer of Flagship Pioneering, a venture firm that creates life sciences companies. He is the former chief medical officer of Merck and former dean of Tufts University School of Medicine. He serves as an adviser to Moderna, which is developing a Covid-19 vaccine; he is not a Moderna employee or shareholder. The opinions expressed are his own and do not necessarily reflect those of Flagship Pioneering or Moderna.

The rest is here:
Challenge trials aren't the answer to a speedy Covid-19 vaccine - STAT

But fast-tracking the rule-making process on foreign workers could invite legal challenges from opponents who say the administration did not follow the rules. Last week, the Supreme Court ruled that Mr. Trump violated the Administrative Procedure Act when he tried to terminate an Obama-era program aimed at protecting young immigrants from deportation.

The government could try and fast-track that process by not allowing the public to weigh in on the changes before they go into effect, but it is difficult to see that process surviving court review, said Lynden Melmed, an immigration lawyer and the former chief counsel of the U.S. Citizenship and Immigration Services.

Amid the pandemic, the Trump administration has seized on the threat to public health as a pretext to issue a series of policy changes affecting almost every aspect of the immigration system, including asylum and green cards. While many changes have been announced as temporary, they could remain in place indefinitely.

But critics say the administration has used the health crisis and the economic meltdown it has caused as pretext to put in place restrictions that further its immigration agenda.

While Mr. Trump and his aides said the suspension of visas was in response to the pandemic, the administration has been pursuing the same broad reductions to legal immigration policies for years, including during times when unemployment was at its lowest in decades. In 2017, the president endorsed the RAISE Act, a Republican Senate bill that would have cut legal immigration, including business visas, by about 50 percent.

In the weeks leading up to the announcement on Monday, a diverse coalition of businesses and research universities had lobbied fiercely, flooding the White House with letters and phone calls, in an attempt to limit the scope of the executive order.

Its the largest crackdown on work visas that I have seen in my 35 years of practice, said Steve Yale-Loehr, a Cornell law professor. Thousands of businesses and universities will be hurt by these restrictions. Similarly, individuals will be stuck overseas unable to help the U.S. economy recover.

Excerpt from:
Trump Suspends H-1B and Other Visas That Allow Foreigners to Work in the U.S. - The New York Times

To create a potential vaccine for SARS in 2003, a group of Canadian researchers had to break the law.

Nearly 800 people died from this viral respiratory condition and some 8,000 infections were reported across the globe. By April 2003, when the SARS Accelerated Vaccine Initiative, or SAVI, was formed in British Columbia, Toronto had been hit with the first of two outbreaks it would experience. Using existing vaccine parts that had already been approved for human trials, the researchers developed three vaccine candidates in less than a year.

In the process, they circumvented university lawyers battling for a piece of whatever profits might come down the line from patents and infringed on the intellectual property rights of scientists who had come before them. Recognizing how devastating this virus could soon become, the researchers behind SAVI prioritized protecting people from it as quickly as possible the law would sort itself out later, they hoped.

No one wanted to grant permission to use their vaccine virus backbone as the SARS viruss if they didnt get anything out of it, says microbiologist Brett Finlay, a professor at the University of British Columbia who led the project. We just went ahead anyway. We figured if SARS really came back ferociously the next year and we thought it would then they [the legal teams representing the parties involved] could figure it out, or mandate it, or legally change it.

A second wave of SARS never came, the members of the team returned to their regular research activities, and those legal quandaries seemingly disappeared.

When it became clearearly this year that Canada would have to contend with a new coronavirusrapidlysweeping the globe,the federal governmentquicklydecidedthat it wouldnt put itself in such a legally precarious position again.TheCOVID-19 Emergency Response Actwas passed in March, giving the government the power to do exactly whatDr.Finlay and his team had counted on back in 2003 to appropriate patented inventions as needed to address a public health emergency.

It seems only logical that to protect lives from a deadly virus, researchers should be able to freely mobilize existing scientific knowledge and tools. And we are seeing that play out today with an unprecedented level of collaboration and knowledge-sharing. Processes that would have taken months or longer now take hours: the Canadian Institutes of Health Research administered $54.2 million for COVID-19 research in the organizations fastest grant competition ever; researchers and clinicians are sharing lab notes and patient treatment protocols in real time, pushing concerns for academic credit aside; scientific publishers are expediting peer review processes and more than a thousand open-access articles on COVID-19 have already been published. The World Health Organization, UNESCO and national science advisors from around the world have called for open data sharing; and the WHO is considering a proposal to make patented diagnostics, drugs and vaccines available to all. Just a few months after the release of the COVID-19 viral genetic sequence by Chinese researchers in January, multiple vaccine candidates are already in clinical trials.

In many ways, the global response to COVID-19 has strengthened the case for open science, a movement that has been gathering momentum in the biomedical fields and beyond over the past few years. Underpinning the movement are principles like open access publishing and the free sharing of data, tools and biospecimens like cells, antibodies and animal models. Where appropriate, like in the case of a vaccine for a viral pandemic, the movement also advocates for an open approach to intellectual property and commercialization.

Its an approach that Mona Nemer, Canadas chief science advisor, has been promoting. There is agreement between funders, publishers and researchers that the only right thing to do in these unprecedented times is to make science related to COVID-19 open as quickly as it becomes available, she says. Collaborations generally come easier to researchers now, as they are fighting a common enemy and time is of the essence. Also unprecedented is the speed at which discoveries are being translated into public health policy. I hope that this experiment will influence peoples views about open science.

Read also: To cure brain diseases, neuroscientists must collaborate: Thats why Im giving my data away

To the average person, it may come as a surprise that science, particularly academic science, which is largely publicly funded, is not always conducted in an open and collaborative way that makes it accessible for anyone to build upon. After we did the SARS rapid vaccine development, people said, Why cant we do this for cancer and all the other major problems in the world? Dr. Finlay recalls. Unfortunately, I had to say that science, as it stands now, doesnt really work that way.

In fact, science today involves paywalls for papers, restricted access to datasets, licensing delays and researchers who sometimes refuse to share their data, says Viviane Poupon, chief operating officer at the Tanenbaum Open Science Institute (TOSI) at The Montreal Neurological Institute-Hospital.

The institution, better known as the Neuro, claims to be the first academic institute to adopt such a model. Its foray into open science with the founding of TOSI nearly four years ago follows that of non-profits like the Structural Genomics Consortium and precedes government open science initiatives, like Canadas Roadmap to Open Science a set of guidelines released by Dr. Nemer in February which outlines steps to make federal science accessible to all and the European Commissions Plan S, which seeks to have all results from publicly funded research published in open access journals by 2021.

Open science aims to overcome what some researchers describe as a culture of competition, secrecy and premature commercialization in science, which slows down the pace of discovery and hampers our understanding of the molecular mechanisms behind the most challenging diseases of our time.

We need to better define what we mean by open science.

In the United States, the Bayh-Dole Act of 1980 gave universities the power to patent innovations funded by public dollars. In Canada, no such law exists although the 2002 Framework of Agreed Principles on Federally Funded University Research, developed by the Association of Universities and Colleges Canada (now Universities Canada, publisher of University Affairs) and the federal government, struck a bargain in a similar vein: it promised universities a doubling of federal funding if colleges and universities tripled their commercial performance, defined in part as income from intellectual property, by 2010.

According to Dylan Roskams-Edris, open science alliance officer at TOSI, the thinking was that if knowledge generated at universities might have commercial application, the best way of making sure that was realized was to apply for patent protection. Universities opened technology transfer offices and patent applications rose. So did the administrative costs of filing those applications.

As a result of this increased patenting, each time researcher materials like a biological sample are transferred from one institute to another, lawyers are tasked with negotiating material transfer agreements to determine who has ownership over any resulting discovery or profit. Negotiations can cause administrative delays of weeks or months when sending even simple reagents between institutions. Sometimes the negotiations fall apart, shutting down scientific projects altogether, says Mr. Roskams-Edris.

When you multiply the delays by the number of scientific interactions between institutions, it amounts to a significant loss of time for IP that is unlikely to actually be of any value, he says. The majority of patents that get applied for and even granted dont end up leading to agreements, let alone products. Yet it costs university technology transfer offices anywhere from $10,000 to $50,000 of public money to file for a single patent, says Mr. Roskams-Edris.

Read also: McGill institute takes open science to a new level

As it turns out, its not uncommon for researchers to try to manage delays by sidestepping intellectual property policies and sharing resources via informal channels even outside of crises. But doing so disproportionately benefits those with seniority and extensive networks of collaborators. When legal negotiations cant be avoided, it is the least well-off institutions and researchers who suffer, says Mr. Roskams-Edris.

Not all researchers agree with Mr. Roskams-Edris and his colleagues at the Neuro that the current system is problematic. Despite the issues they faced researching a SARS vaccine, Dr. Finlay says hes not entirely sure that science is actually hindered or slowed by these IP processes. He says that seasoned researchers know to avoid or go around institutions that tend to have onerous processes in place for patent negotiations.

But if laws and institutional policies are too costly or have to be circumvented to get results, should those policies be changed? What could be achieved if researchers worked more openly all the time, and not just in times of crisis?

The Neuro adopted an open science framework in 2017, after an 18-month consultation that saw 70 principal investigators and 600 other scientific faculty and staff members opt in to the experiment. The goal? To accelerate understanding of central nervous system diseases. We barely understand the molecular pathogenesis of Alzheimers disease, of Parkinsons disease, of Frontotemporal Lobar Dementia. Were still trying to understand whats happening at a molecular level, says Jason Karamchandani, a neuropathologist at the institute.

The transition required the institution to expand its existing open-source data and project management software, build a biobank a collection of biospecimens and develop an open transfer agreement that eliminates the majority of intellectual property claims when institutions share materials. The Neuro is also working on a toolkit for quantitatively measuring the impact open science has on innovation.

Such infrastructure is essential to practicing open science over the long term, says Dr. Nemer, who cites the Neuros model as one to follow. Having agreement ahead of time on standardized protocols, approvals and format of research output actually adds value to the resulting data, which can then be easily compared among researchers in different institutions, provinces and countries, she says.

A key aspect of the Neuros experiment is the institutes Clinical Biological Imaging and Genetic Repository, or C-BIG. The collection of biological samples, clinical information, imaging and genetic data includes pluripotent stem cells, a unique tool derived from the institutes patients. These cells are self-renewing and can be reprogrammed and grown into neuron cells and organoids, or collections of cells, called mini-brains. They give researchers an unlimited source of brain tissue on which to conduct tests and develop new therapies. This is brand new, says Dr. Karamchandani. Weve had bits of cancer but we havent had the tissues involved in neurodegenerative disease. These cells are a new tool in allowing scientists to investigate these diseases and theyre sharable because we can create more of them.

C-BIG features more than 24,000 specimens collected by researchers over the last three years. Samples are collected from the same patients over time, providing insight into diseases like multiple sclerosis, which is known to impact the body differently during active and dormant periods. Unlike traditional biobanks, which pool cells between established collaborators, Dr. Karamchandani says C-BIG will be open to any researcher. Its about anyone who has a good scientific question being empowered to conduct meaningful scientific interrogation, says Dr. Karamchandani. And its an example of how open science can level the playing field and encourage diverse collaborations the platform goes live to the public later this year and yet its already led to partnerships with the Canadian Open Parkinsons Network and Capture ALS.

Researchers who publish in the open are more widely read. They also reach a more diverse audience, are cited more often and have a higher chance of making an impact.

But its not a data free-for-all. The institute has implemented a three-tiered data classification structure for C-BIG: data that poses no risk to patients like demographics are available open access; more detailed genetic and phenotype data are accessible only to researchers who register with the institute; and access to biosamples that could re-identify patients when cross-referenced against other databases is determined by committee review.

C-BIG also feeds the Neuros Early Drug Discovery Unit (EDDU). The unit brings together researchers and industry partners to identify molecular targets that hold promise for the drug-development process. The institute has partnered with multinational pharmaceutical companies like Merck and Takeda, as well as open science biotech firms M4K and M4ND Pharma. Over the last three years, a third of the units $25-million in funding has come from industry.

Researchers investigating a question like whether a specific molecular mechanism has implications for Parkinsons, work together and with industry on procedures for analyzing the effects of a compound or drug on a diseased cell. That partnership gives pharmaceutical companies and biotech firms direct access to research expertise while providing investigators with funding and early access to new technologies developed by the companies. The open transfer agreement also requires companies to share with the Neuro the results from investigations that make use of the institutes platforms and specimens, something that Dr. Karamchandani says doesnt happen with most traditional collaborations.

Even with these rules, industry has been eager to collaborate because progress on drugs targeting central nervous diseases has been slow, says EDDU associate director Tom Durcan. We havent really seen anything new pretty much in the last 10 years, he says. In a way, the pipeline is broken for both of us.

The Neuros success in bringing biopharmaceutical partners on board is a testament to its efforts to collaborate with private sector and to better understand how open science can contribute to business and commercialization while also benefitting academic research. Reconciling the two remains one of the biggest barriers to wider implementation of the open model the huge cost just to take a drug through clinical trials is one of the main justifications for pharmaceutical patents.

What we need is a balance between public knowledge without IP and private knowledge with IP, says Mr. Roskams-Edris. Public institutions should be producing the best possible quality public knowledge that private interests can then use as the base for their own private development.

Dr. Poupon sees the early-stage research that academic scientists do as a complement to the role pharmaceutical and biotech companies play in drug development. You take high risks when you develop a molecule commercially, and it takes a lot of time and investment, she says. Its a very specific business that is not what academia does and we totally respect that.

However, some prospective private-sector partners remain skeptical due to what they see as a lack of clarity around a business model based on open science. We need to better define what we mean by open science, says Diane Gosselin, president and chief executive officer at the Consortium Qubcois sur la Dcouverte du Mdicament, a biopharmaceutical research consortium funded by public and private donors. CQDM aims to support early-stage, high-risk research that leads to tools for scientific discovery, and has partnered with the Neuro on a platform to identify new drugs for Parkinsons Disease and ALS.

For Dr. Gosselin, open science is a collaborative way of working between academic and private institutions where both parties benefit. It doesnt mean that theres no IP all the time, she says. Instead, she believes whether and how IP might be applied down the line should be addressed in the early stages of such collaborations.

Ownership over discoveries also poses a challenge for the open science model in academia. For his part, Dr. Karamchandani thinks universities will be hesitant to give up their IP because its been deemed a measure of success for universities in Canada, and even for individual investigators, he says.

At the Neuro, initial concerns over whether the switch to open science would keep young researchers away have eased now that its attracted more than 30 new trainees. Nevertheless, the issue of how to acknowledge the contribution of individual researchers remains a barrier to implementing open science, especially in academic institutions. Science is a competitive business and you dont just go and tell everyone your very best data long before you publish it because then others might beat you to it, explains UBCs Dr. Finlay. Your tenure and promotion are all based on your abilities to publish and unless we come up with a better way of defining someones abilities as a scientist thats not based on peer reviewed papers, then that competition is always going to be there.

To address this issue, the Neuro is developing additional evaluation criteria, including whether the investigator has released open source datasets or published open source code. Its also experimenting with researcher resource identification, a type of digital barcode for cell lines developed by the EDDU, as an alternative to using patents for documenting the evolution of a discovery.

Still, staff at the Neuro know that widespread buy-in on an open science model will take time and education. Even when youve designed a better system, people who have traditionally operated in a different and more closed system are going to take some significant convincing, Mr. Roskams-Edris says.

Even when youve designed a better system, people who have traditionally operated in a different and more closed system are going to take some significant convincing.

Time will tell if the volume and speed of collaboration inspired by the COVID-19 crisis will be a watershed moment for the open science movement. Dr. Nemer, for one, is optimistic. The COVID-19 pandemic is demonstrating to the research community that working in the open is not only doable, but is also beneficial to the researchers and knowledge-users, she says. Researchers who publish in the open are more widely read, both domestically and internationally. They also reach a more diverse audience, are cited more often and have a higher chance of making an impact.

Just as the flu pandemic of 1918 drove the creation of global health agencies and helped make a case for socialized medicine, so too could the present pandemic inspire a change in the way we address the medical and scientific challenges of the next century.

Originally posted here:
Could the Montreal Neuro herald a paradigm shift in scientific research? - University Affairs

The Global Next-Generation Sequencing market report presents market dynamics focusing on all the important factors market movements depend on. It includes current market trends with a record from historic year and prediction of the forecast period. This report is a comprehensive market analysis of the Next-Generation Sequencing market done on a basis of regional and global level. Important market analysis aspects covered in this report are market trends, revenue growth patterns market shares and demand and supply along with business distribution.

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Legal and ethical discussions are the part of medical research. Journals and funding agencies are submitting the genomic data from the research contributors to the databases are allowing the investigators for controlling the data. The samples and data are sent from databases without the approval of participant by pushing them at risk. Unidirectional flow of data are creating the sense of distrust and exploitation. As a result, ethical and legal issues are hampering the next generation sequencing market growth.

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Global next generation sequencing market are end-user, application, technology, product & service and region. On considering the end-user, market is divided into biotechnology & pharmaceutical companies, clinics & hospitals, academic institutes and research centers and more. On the basis of application, market is divided into animal & agricultural research, drug discovery, other diagnostic applications, reproductive health diagnostics, infectious disease diagnostics, cancer diagnostics, diagnostics and much more. Based on technology, market is divided into nanopore sequencing, single-molecule real time sequencing, ion semiconductor sequencing, sequencing by synthesis and more. By product & service, market is divided into bioinformatics, sequencing services, services for NGS platforms, NGS platforms, NGS consumables and pre-sequencing products and services. Bioinformatics further subdivided into NGS storage management & cloud computing solutions, NGS data analysis services and NGS data analysis workbenches & software whereas sequencing services are divided into De Novo and Whole genome sequencing, RNA sequencing, Custom Panels and Exome and Targeted Sequencing. NGS platforms are further sub-divided into Oxford Nanopore Technologies, Pacific Biosciences, ThermoFishcer Scientific, Illumina and others. Pre-sequencing products & services market is divided into quality control, target enrichment & library preparation, size selection, A-tailing, End Repair and DNA fragmentation.

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By Application, market is segmented into:

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Next-Generation Sequencing Market: Understanding The Key Product Segments And Their Future During 2020 -2025 - 3rd Watch News

Human embryo goes through a process of gastrulation, which occurs during early development where isotropic cell groups transform into ensembles of tissue. Despite many restrictions in studying gastrulation, scientists have created an embryo-like blueprint for birth defect and disease detection from stem cells.

A team from the University of Cambridge gained new insight into the development period of gastrulation; what they call the 'black box' period. Due to ethical and legal issues that prohibit ex vivo observations, the scientists created a model that resembles an embryo. Laws prohibit scientists to culture embryos in a lab beyond two weeks, the point where gastrulation begins, making it impossible to study the black box period before the new study.

Alfonso Martinez-Arias, a geneticistfrom the university, said that their model 'produces part of the blueprint of a human...It's exciting to witness the developmental processes that until now have been hidden from view - and from study.'

During this black box period, three layers of cells form the ectoderm, mesoderm, and endoderm. These cells proceed to form the nervous system, muscles, and gut.

Professor Martinez-Arias and the team set embryonic stem cells into 'small wells,' creating 'gastruloids.' Gastruloids resemble human embryos during the premature stages of development, around 18-21 days after being conceived.

The embryo models were then treated with chemical signals, proceed by lengthening along a head-to-tail axis. This activity triggered genes to form specific patterns which displayed a 'clear signature' for the development of various body parts. If it were a real embryo, the process would eventually result in specific body structures such as muscles, bones, and cartilages.

Naomi Moris, another geneticist from Cambridge, shared that 'This is a hugely exciting new model system, which will allow us to reveal and probe the processes of early human embryonic development in the lab for the first time.' The newly developed system may 'prove useful for studying what happens when things go wrong, such as in birth defects,' she continued.

The gastruloid model may help pinpoint specific causes of birth defects or diseases that begin during gastrulation such as alcohol consumption, harmful medication, substance abuse, and other forms of infections. Genetic disorders can also be more understood, as well as what causes infertility and miscarriages.

Read Also: 5 Proven Advantages and Disadvantages of Stem Cell Research

Until recently, scientists have only conducted studies on mice and zebrafish embryo, which most likely have genetic differences with human cells during the gastrulation process. Moreover, non-human models respond differently to certain chemicals such as morning sickness medication for pregnant women. This results in clinical trials passing for animal models yet could be severely harmful to humans, causing birth defects.

Joyce Harper, a reproductive expert from the University College Londonand is not a co-author of the new study, knows that gastrulation is a highly critical stage in life development. ''But up until now, we have never been able to study it in humans [models]...this exciting work will allow many key studies to be done so we can learn about early human development and when it goes wrong,' she said.

Read Also:Aspirin Could Prevent Preeclampsia but 50% of Pregnant Women at Risk Miss Out on this Drug: Study

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Meet 'Gastruloid': The First Human Embryo-like Model From Stem Cells That Could Soon Save Many Babie - Science Times

Professor Michael P Lisanti, Chair in Translational Medicine at the University of Salford, has been an active research scientist for more than 30 years and is an expert in the field of cellular senescence. He tells HEQ about the potential of readily available, low cost, MHRA- and FDA-approved drugs to possibly treat and prevent the spread of COVID-19.

Senolytic drugs can be used to prevent or reverse ageing. There have been studies in mice that have shown that if you use a genetic trick, you can reverse ageing-associated disease characteristics but the problem is you cant do that in humans, so you would need a drug. We set out to identify drugs that would selectively kill senescent cells, but not harm normal cells; for this purpose, we developed a drug screen where we looked at various agents which prohibit cancer stem cell activity and we came across azithromycin, which selectively killed senescent cells with efficiency of nearly 97% and did not harm the normal cells. When we looked at the literature, we saw that patients with cystic fibrosis had been treated with azithromycin cystic fibrosis is similar to accelerated ageing as a disease, because theres a huge amount of inflammation and fibrosis and it dramatically increased their lifespan and their survival rates.

Fibrosis is normally an ageing-associated disease characteristic: its what kills patients with cystic fibrosis, because their lungs become stiff and can no longer expand and contract, in order to breathe. The azithromycin was also behaving as an antifibrotic, removing or preventing the formation of senescent myofibroblast cells; so we actually had proof In previous studies that our drug was actually a senolytic. If you reread the literature with senolytic glasses, you realise that the proof of its efficacy in humans is already there.

Another study in Japan looked at azithromycin based on its activity in cystic fibrosis patients and then applied these finding to patients with idiopathic pulmonary fibrosis. The control group survival rate in that paper was 25%, but on azithromycin it was nearly 80%. There is evidence in the published literature that its either preventing or removing fibrosis which is consistent with our data, but nobody thought about cystic fibrosis or about idiopathic pulmonary fibrosis as diseases of senescence: they thought it was preventing the formation of the myofibroblasts, but we believe it was killing the myofibroblasts, which are now known to be senescent cells.

The reason you want to get rid of the senescent cells is because they are actually contagious. They secrete IL-6, which is an inflammatory mediator; and they make other cells senescent by diffusion of the inflammatory mediators, which explains why as you get older you accumulate more and more senescent cells. By the time youre 40 or 50 years old, you have aches and pains and you feel stiffness: these are a symptom that you are beginning to accumulate senescent cells.

All of this is very reminiscent of what happens in patients with COVID-19. Fatality rates are much higher in older patients and in patients with ageing-associated diseases, such as diabetes or coronary artery disease. IL-6 levels have been shown to be the best predictor for whether or not a patient will to wind up on a respirator and these patients may die from inflammation in the lung and the resulting fibrosis. It all sounds similar to a very acute episode of either cystic fibrosis or of idiopathic pulmonary fibrosis.

The virus has something called a host receptor, which allows the virus to bind the surface of the cells and then get internalised. For COVID-19, there are two proposed host receptors: one is CD-26, which is a marker of senescence; and the other one is ACE-2, which is also increased during senescence. This would suggest that the virus is preferentially targeting cells with markers of senescence.

We think of senescent cells as old and not very energetic, but they have to secrete a lot of inflammatory mediators, like IL-6, so they actually have very active protein metabolism and they do a lot of protein synthesis IL-6 is a protein and they produce inflammatory mediators of the senescence associated secretory phenotype (SASP). Therefore, the virus would want to invade a cell that is better at protein synthesis in order to make more copies of itself and the necessary viral spiked glycoproteins, to package the viral RNA or DNA for viral replication. This virus is seeking out the cells that are the best at making protein, to make more copies of itself, so it gets in the cell and takes over.

The predilection for fatalities in patients with advanced chronological age suggests there is a connection with senescence; and azithromycin, which appears to be working in clinical trials, is a senolytic and an antifibrotic. Certain antibiotics of the azithromycin class of which there are many are inhibitors of protein synthesis. The same is true of tetracyclines like doxycycline. These drugs would inhibit protein synthesis, so they would block IL-6 production and also block viral replication. Azithromycin has been shown to inhibit Zika virus and Ebola virus replication; and doxycycline has been shown to inhibit Dengue virus replication. Any drug which is a protein synthesis inhibitor, like certain classes of antibiotics, would also inhibit viral replication not because of any characteristics specific to the virus, but because its inhibiting protein synthesis, which is required for their viral replication.

The question, then, is why we cant use these drugs now in the clinic. In the United States, if a drug is prescribed off-label, its perfectly legal: the FDA approves a drug after Phase 1, Phase 2 and Phase 3 clinical trials for a particular indication. Then because the drug already went through Phase 1, which is a safety trial, it can be legally prescribed for any other disease indication off-label. The FDA will not actually have to directly approve doxycycline or azithromycin for treatment of COVID-19, because doctors can already prescribe it.

In a time of crisis, we need to practise what people are calling battlefield medicine, where we think outside the box. Theres already evidence in the published literature that these antibiotics have the protein synthesis inhibition side effect and have already been shown to inhibit viral replication. The problem in this country is people are rightfully afraid of antibiotic resistance. Its the kind of thing that has been ingrained in the mindset of doctors in the UK. However, I think we need to rethink the whole use of antibiotics to target viral infections. In fact, if you look in the literature for herpes virus (HSV), its already been shown that erythromycin, which is another protein synthesis inhibitor, is used either orally or as a cream to treat herpes outbreaks.

If we could give NHS workers either doxycycline or azithromycin prophylactically, the viral load would likely be gone or severely diminished. This would prevent the spread of the virus from one person to another, protecting clinicians against people who come to the hospital; and could also be used to treat patients. But, I think the key here is to avoid the fibrosis and the inflammation, which starts with the fever. When a patient comes down with a fever, they should immediately give them the doxycycline or the azithromycin, which will shut down IL-6 production and shut down the viral replication; so the patient is less likely to transmit the disease to healthcare workers.

All these drugs are very inexpensive the cost of doxycycline is 10 pence a day; azithromycin is also very cheap, because it came off patent in 2017 so these drugs could be used for prophylaxis and for treatment. Then potentially we could relax some of the social distancing and we could all go back to work. The problem is were not going to have vaccines for another 12 to 24 months, so we need something now thats already safe, thats MHRA- or FDA-approved for at least one indication. It may be something that can be used in conjunction with social distancing: some people dont have extra space in their house where they can really isolate, so then they could take an antibiotic like doxycycline or azithromycin to reduce viral loads. This would reduce the stress on the healthcare system, because if you treat people in the early stages and it works, they wont get to the ventilator stage and the problem is when you get to the ventilator stage, the patients lungs have effectively turned to cement from all the fibrosis, so the chances of getting people off the ventilator is rather low. Its very serious once you get to the ICU, so you want to prevent the onset of respiratory symptoms, by treating patients as soon as possible with an antibiotic that will shut down viral replication.

Doxycycline is the number one drug prescribed worldwide for any indication: its used for malaria, its mainly used for acne; and people will take it for six months at a time without any real issues, except maybe some stomach upset. People with acne rosacea take it for their whole life, especially in very disfiguring cases usually they recommend a drug holiday for a week or two, every six months. Doxycycline was approved first in 1967. Its not a senolytic, but it does inhibit IL-6 and it inhibits viral replication; and it has been shown by other people to be an anti-ageing drug as well. Both of these drugs are very cheap; and they should be in abundant supply worldwide.

SARS-CoV-1, the precursor for COVID-19, shows the same pattern of infection. They conducted experiments in humans and mice and saw that, for example, young mice will become infected, but it doesnt cause any real disease there is no inflammation or fibrosis; and a very mild pneumonia but if they use older mice aged 12 to 14 months, they see very severe inflammation, fibrosis and death. This is due to the induction of a very strong inflammatory response, which includes the IL-6. This original mouse model could be used to test this hypothesis regarding senolytics, but as these drugs are already FDA-approved, we can do that in parallel. The problem is its a question of time; and the longer we wait, the more people are infected, when we could just shut it down now. We could use patients already in hospital, you would have instant clinical trials. This is battlefield medicine. We should take advantage of the patient population with drugs that have very few side effects, and conduct clinical trials on a large scale.

I think people are in a state of helplessness. They dont know what to do, and the solution could be right under our noses. What were doing is not working, for many patients, and we need to change something; and the first step would be propagate the idea of field clinical trials. We can record all the data from the treatment of the patients as it progresses thousands of people have the disease and it could be a multicentre trial, the most important thing is to get something going now.

Much research into the treatment of COVID-19 is currently focused on the drugs chloroquine and azithromycin; and the FDA has granted an emergency licence for the use of chloroquine to treat COVID-19 patients. The European Medicines Agency has not yet followed suit, asserting that more research should be conducted; and some researchers have highlighted concerns over toxicity issues associated with chloroquine and its derivative, hydroxychloroquine.

Patients who are prescribed chloroquine or hydroxychloroquine normally would have to take a test for a glucose-6-phosphate dehydrogenase deficiency (G6PD) [an hereditary condition which increases the risk of haemolysis when chloroquine is administered]; and there are other issues with both chloroquine and hydroxychloroquine. I think the side effects may outweigh the benefits, because its not an inhibitor of viral replication; its an inhibitor of viral entry. If the patient is already sick, they already had the viral entry, then chloroquine will not necessarily shut down the viral replication. It only works for patients who have not already been infected.

In the clinical data from the French trial of hydroxychloroquine and azithromycin, the chloroquine did relatively little by itself and that has been called into question in terms of the effects. The combination with azithromycin was much more effective, but they didnt test azithromycin alone, which would probably be sufficient; because even if viral entry does occur, as long as the viral replication is inhibited, the virus will not propagate. We believe that the hydroxychloroquine isnt necessary; and we can reduce the risk to older patients by eliminating the hydroxychloroquine.

Azithromycin has some very mild side effects, but theyre not very prevalent; if they had been prevalent the drug would have been pulled off the market. There was some controversy as to the reproducibility of the studies regarding its side effects: multiple studies were done and some are positive, some are negative, so theres still a warning out there but the side effects only really occur with high doses of azithromycin, which would not be needed in this case. If azithromycin did cause problems for a patient they could switch to doxycycline, or they could start with doxycycline in the first place. These are just two examples of classes of drugs; there are other drugs which inhibit protein synthesis: erythromycin is in the same class as azithromycin, and it inhibits protein synthesis. It doesnt have the senolytic activity, but it would still inhibit the IL-6 and the viral replication.

The same is the case for the tetracyclines these are classes of drugs which are relatively similar and interchangeable, so if we run out of doxycycline, we would still have minocycline, tetracycline and all these other variations which have a similar effect on protein synthesis. The main issue with doxycycline is patients can experience some stomach upset or some nausea, but this can be alleviated by using a probiotic.

That would be the primary role of these drugs. Based on the results of clinical trials, the NHS could implement its usage. For example, ICU staff could receive it first, as they are in contact with patients that pose the most severe risk. Hospital staff right now are probably terrified of catching it, so why not take a prophylactic antibiotic, which has a chance of preventing infection? Im sure theyre doing a great job taking care of the patients, but it is traumatic to be under all this stress constantly. Its very stressful to be in such a high pressure situation, where youre afraid for your own life, but youre also trying to help other people at the same time. Then, you have your family at home and you dont want to also make them sick either. Healthcare workers are the people who are at the greatest risk; and already weve seen a reduction in NHS staff levels around one in four NHS staff are not at work, because they have either been infected or are isolating because they have symptoms.

We dont want to lose too many of the doctors and nurses in this crisis, so this would be helpful for everyone especially for preventing the further spread to shut down viral replication and contagion. Anything that can be done to reduce the viral load will reduce the contagion. They can do trials with young healthy volunteers who are asymptomatic, but it would be better to do it with the NHS staff who would need it most as a preventative approach for prophylaxis. We have recently proposed and published this prophylaxis strategy in a Letter to the Editor at the British Medical Journal (BMJ), which is widely read by GPs and consultants in the UK.

1 Letter to the Editor, British Medical Journal: https://www.bmj.com/content/368/bmj.m1252/rr-20

2 Lisanti, Sotgia et al. (2020). Senescence, ageing and potential COVID-19 treatments. Aging-US. https://www.aging-us.com/article/103001/text

Professor Michael P Lisanti, MD-PhD, FRSA, FRSBChair in Translational MedicineSchool of Science, Engineering & EnvironmentUniversity of Salford+44 (0)1612 950 240M.P.Lisanti@salford.ac.uk

This article is from issue 13 of Health Europa. Clickhere to get your free subscription today.

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Could these senolytic drugs halt the spread of COVID-19? - Health Europa

Scientists, drugmakers and governments are moving with unprecedented speed to deliver a vaccine to protect against the new coronavirus.

The fastest of them have already delivered preliminary data from human studies, and further results from others should come quickly as the year progresses.

The goal, at least in the U.S., is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world.

Use the buttons below to highlight events in each company's timeline. Solid dots indicate events which have occurred, while striped bars indicate company estimates for when an event will occur. Current projections assume clinical development succeeds and progresses on time, neither of which are certain to happen.

Use the dropdown to highlight events in each company's timeline. Solid dots indicate events which have occurred, while striped bars indicate company estimates for when an event will occur.

First volunteer given vaccine

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Nami Sumida/BioPharma Dive

Researchers' success or failure could determine whether the virus becomes endemic, recurring in countries around the world year after year, or is ultimately checked.

With the health of their citizens at stake, governments are investing enormous sums of money into vaccine research and development, and to prepare for manufacturing and distributing what will likely need to be hundreds of millions of doses necessary to keep infection at bay.

With modern-day Manhattan Projects underway, vaccines have become an issue of national security, raising questions of global equity and medicine access.

In the U.S., the Trump administration has unveiled "Operation Warp Speed," pledging billions of dollars of funding and support for an initial, and as yet unconfirmed, slate of candidates.

There's no guarantee the first successful vaccine will come from the U.S., however. Some of the leading candidates are being developed overseas, with projects by China's CanSino Biologics and the University of Oxford in the U.K. the furthest along.

The rest of the world might not be so lucky.

As Emory University vaccines expert Walter Orenstein said in an interview with BioPharma Dive, "It's not like we can expect 7 billion doses the day after licensure so we can vaccinate the whole world." Yet, to truly curb circulation of the SARS-CoV-2 virus in humans, getting vaccines to nations wealthy and poor will be a vital mission.

For scientists, many questions remain unanswered.

The first trials to produce data have avoided any safety issues that can sideline a project for good, and have established they can stimulate an immune response. But what about less common side effects only detectable in massive trials? How good will vaccines be at preventing actual infections?

The next six to nine months should produce a flurry of data, early answers and fresh questions, making it difficult to keep track. Here's where things stand for nine of the most advanced, most promising, or best funded vaccine candidates in the pipeline.

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The coronavirus vaccine frontrunners have emerged. Here's where they stand - BioPharma Dive

June 8 has been marked as World Ocean Day by United Nations. This year's theme 'Innovation for a Sustainable Ocean' is indication of proper management and regulation of ocean resources. The area possesses more than 60% of the earth surface with abundance of diverse living and non-living resources having rich variety of organisms. Such valuable resources are potentials for invention of new medicine and drugs, cosmetic, consumption products and other possibilities for greater contribution to humankind in future. UNEP published that compounds from deep seabed organisms have been used as basis for potent cancer fighting drugs, commercial skin protection products providing higher resistance to ultraviolet and heat exposure, and for preventing skin inflammation, anti-viral compounds and anti-allergy agents. Therefore, regulation of the ocean commons and its resources is imminent for the greater interest of international community as a whole in general and developing countries in particular.

One of the significant challenges recently explored by these nations is regulating rich marine genetic resources (MGRs) particularly in areas beyond national jurisdiction (ABNJ) which includes high sea covering water column of the ocean beyond 200nm from the baseline and the Area which consists of the ocean floor, sea bed and subsoil of area beyond outer limits of continental shelf. The reason includes that a number of products are already in the market and more are in the process from these MGRs. This is surely an opportunity for nations and companies who have capable technologies. But the confrontation is that exploration and exploitation of MGRs from ABNJ cannot be questioned before any forum under existing international legal mechanism. Another concern is the indiscriminate use of such bio components and contamination of their conservation and sustainable use would possibly limit the benefit for future generations and for all nations.

The complexity has further been condensed due to the division of States on the question of freedom of high sea versus common heritage of mankind. UNCLOS, although considered as the constitution of ocean, is silent on this point perhaps for the reason that very little was known about genetic qualities of organisms found on deep seabed or on the high sea during its adoption.

Nations are adamant on their position. Bangladesh, India, China and other G-77 members have raised their concern and regularly participating at the UN working groups and negotiation processes to place their justified demands on regulating MGRs within the spectrum of common heritage principle. According to them, the resources should be governed in the similar model of International Seabed Authority under Part XI of UNCLOS. Their argument has further been justified by the UNU-IAS Report which suggested that in exploring and exploiting mineral resources including polymetallic nodules, biological resources are intrinsically linked with mineral resources in the deep sea ecosystem.

Therefore, sampling of biological resources may be occurred and would certainly be easy task and hence it has been suggested that several features of Part XI may be extended to MGRs. The support for common heritage and ISA modeled regulation would allow entitlements to the benefits arising out. It seems that the whole debate between countries on common heritage of mankind dividing the world during 1970s had been reinvigorated in the present context. USA, EU, Japan and Korea are asserting that principle of freedom of high sea is governing MGRs and bioprospecting. Arguments put forwarded that activities related to the exploration and exploitation of marine biological resources can be performed without specific regulations since part VII of UNCLOS governs very well.

It is undeniable that there exists a gap in regulating MGRs of ABNJ. Therefore, efforts have been undertaken by UN since 2004 onwards. UN General Assembly (UNGA) established an Ad Hoc Open Ended Informal Working Group to study issues pertinent to conservation and sustainable use of marine biological diversity beyond the areas of national jurisdiction (BBNJ Working Group). In 2011, the Working Group recommended UNGA to initiate a process in order to address that a legal instrument be brought under UNCLOS for conservation and sustainable use of marine biodiversity in areas beyond national jurisdiction. BBNJ working group held its final session in 2015 and forwarded recommendation to UNGA on elements of draft text to be adopted under UNCLOS. For the said purpose, organizational session was held in 2018 which set the plan of organising four intergovernmental conference sessions. Three sessions were held and fourth one was postponed. After the forth one, nations will find some possible way out.

We are not well aware about the resources in deep sea and their potential use for curbing global challenges. But it is quite certain that with the advancement of science and technology, nations will be aware and largely benefit from ocean resources that belong to all. Hence, it is imminent to sustainably use the ocean particularly regulate MGRs in ABNJ. Developing and other disadvantageous nations must continue their efforts to place common heritage regime. The role of Bangladesh in this regard would be well recognised.

The writer is Assistant Professor, School of Law, Brac University.

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Regulating marine genetic resources in areas beyond national jurisdiction - The Daily Star

Gottsdanker was one of 120,000 children inadvertently injected with the live infectious poliovirus from a vaccine manufactured by a northern California laboratory. About 70,000 people developed muscle weakness, 164 were severely paralyzed including Gottsdanker and 10 died.

Now, as President Trump vows to distribute a COVID-19 vaccine by years end under a program called Operation Warp Speed, she worries that the ambitious plan could backfire. Despite the remarkable success of vaccines in the 20th century, several immunization efforts even Salks triumph over polio have harmed some of the people they were supposed to protect. Health experts say haste or carelessness played a role in those missteps.

It horrifies me, said Gottsdanker, 70, a retired college professor in Lancaster, Calif., who uses a wheelchair, has multiple health problems, and would welcome a coronavirus vaccine, as long as it has been proven safe. What people dont realize is that when a person catches a disease through a vaccine, it wont just affect them then. It will affect their entire life.

Some scientists who have worked on vaccines, as well as historians who have studied them, share her concern. If a poorly designed or manufactured vaccine is distributed, they argue, it could erode public confidence in vaccines in general and exacerbate declining rates of childhood immunizations, already a serious problem.

But Dr. Francis Collins, director of the National Institutes of Health, which is involved in Operation Warp Speed, said the Star Trek-evoking name reflects technological breakthroughs that have made it possible to develop and test vaccines on humans faster than ever.

The Cambridge biotech Moderna, he noted, began testing the first potential COVID-19 vaccine in a clinical trial a mere 63 days after company scientists obtained the genetic sequence for the virus. Moderna is injecting genetic material that instructs cells to make proteins that provoke an immune response. Researchers have explored that approach for several years, but it has yet to produce an approved vaccine.

Its not about cutting corners when it comes to safety and efficacy, said Collins, who discovered the genes associated with a number of diseases and led the Human Genome Project of the 1990s. The warp speed part is to figure out how to do all the right things but cut out the delay. I want to be very reassuring about that.

Trump unveiled the program on May 15 at a Rose Garden news conference. The aim, he said, was to make hundreds of millions of doses of a vaccine available by years end through a partnership between the government and drug companies. Traditionally, vaccines take years, if not decades, to develop. Trump likened the new effort to the World War II-era Manhattan Project, which produced the first nuclear weapons.

Although Trump questioned the safety of vaccines before he became president he repeatedly cited a discredited link between childhood vaccines and autism the scientific evidence that their benefits far outweigh risks is overwhelming.

Dr. Paul Offit, author of The Cutter Incident: How Americas First Polio Vaccine Led to the Growing Vaccine Crisis, a 2005 book about Gottsdanker and other children infected with the live poliovirus, wrote that no single medical advance had a greater impact on human health."

Vaccines have completely or largely eliminated such dreaded diseases as measles, diphtheria, rubella (German measles), whooping cough, and polio in the United States. Smallpox, a scourge estimated to have killed 500 million people worldwide, was officially declared eradicated in 1979, according to the World Health Organization.

Nonetheless, that remarkable record has occasionally been marred by blunders in which haste conspired with problems in design or manufacturing to produce a vaccine that was ineffective or dangerous.

No episode illustrates the high stakes more than the largely forgotten debacle at Cutter Laboratories in Berkeley, Calif., one of the worst pharmaceutical disasters in history.

Polio terrified Americans in the 1950s, when it ranked second only to the atomic bomb as the biggest fear in public opinion polls. Deadly summer outbreaks prompted parents to keep children away from swimming pools and movie theaters. Photographs of young polio survivors with heavy braces on withered legs or bed-ridden in iron lungs fueled the urgency to find a vaccine.

On April 12, 1955, scientists announced that the Salk vaccine made from a killed poliovirus had been tested on nearly 2 million children and was safe and effective. Six days later, Anne Gottsdanker and her 7-year-old brother, Jerry, were injected with the vaccine by their pediatrician. It had been manufactured by Cutter, one of five companies that obtained Salks formula.

But Cutters vaccine contained the live poliovirus, not a killed one to stimulate an immune response without making people sick. The company had departed from Salks safe production protocols as it hurried to make the vaccine, including how long the virus must be treated with formaldehyde to inactivate it.

Mass production is actually the hardest part of making a vaccine, Offit, author of the Cutter book, said in an interview. He directs the Vaccine Education Center at Childrens Hospital of Philadelphia and is co-inventor of a vaccine to prevent rotavirus infections, which cause diarrhea. Cutter, he said, made it badly.

Jerry Gottsdanker didnt get sick, but Anne lost complete use of her right leg and most of her left leg.

A suit filed against Cutter by her family and that of another injured child went to trial in 1957 in Oakland, Calif. The legendary personal injury lawyer Melvin Belli represented the Gottsdanker family. He had Anne walk with her crutches in front of the jury.

It was embarrassing," she recalled. Of her paralyzed legs, she said, You dont lose the feeling, but the motor neurons are killed off. You tell your leg to move, and it just goes, Really? You want me to do what?'

The jury awarded the two children and their families a total of $147,300 in damages.

Cutters devastating mistake led to rigorous government regulations of vaccines. But the legal precedent also discouraged drug firms from making vaccines for other diseases, Offit said. That trend that has only begun to change with the COVID-19 epidemic. As of last year, only four major drug companies were manufacturing vaccines.

In 1976, there was a different kind of vaccine debacle.

That February, an Army recruit at Fort Dix in New Jersey died from the flu, and other recruits fell ill. Two weeks later, health officials blamed a new form of swine flu that appeared to be eerily similar to the strain that caused the 1918 Spanish flu. That pandemic is blamed for at least 50 million deaths worldwide, according to the Centers for Disease Control and Prevention.

President Gerald Ford hastily convened a group of scientists to assess the situation and in March announced a government-funded plan to vaccinate every man, woman, and child in the United States." More than 40 million people soon got vaccinated, including Ford, who was photographed smiling as the White House doctor jabbed him.

But it turned out that the 1976 flu wasnt related to the 1918 virus. People who were infected suffered only a mild illness. The vaccine, however, caused side effects in some children, including high fevers and sore arms. And several hundred people who were inoculated developed Guillain-Barre syndrome, a rare disorder in which the bodys immune system attacks nerves, although it remains uncertain whether the vaccine was responsible.

Some critics accused Ford of manufacturing a public health emergency to boost his reelection prospects, but David Oshinsky, a Pulitzer Prize-winning historian, said he believes Ford sincerely wanted to avert an epidemic. Nonetheless, Oshinsky said, the rush to deploy an ill-conceived vaccine undermined the faith that many Americans had in science, sowing the seeds of todays anti-vaccine movement.

There are public opinion polls that say 50 percent of people will take a COVID-19 vaccine when it comes out, said Oshinsky, director of the Division of Medical Humanities at the NYU School of Medicine, who recently cowrote an article in the Journal of the American Medical Association about the dangers of rushing a vaccine. That means that 50 percent wont take it, and that has a direct correlation with the anti-vaccine movement gaining traction as a result of what happened in 1976.

A recent episode on the other side of the world illustrates how a vaccine can backfire if isnt rolled out cautiously.

In 2016, the government of the Philippines began a massive campaign to inoculate nearly 1 million schoolchildren with the first vaccine for dengue fever. A painful mosquito-borne tropical disease, dengue afflicts hundreds of millions of people around the world.

Sanofi, the French pharmaceutical giant, had worked on the vaccine for 20 years and tested it on more than 35,000 children. The company shared its results in a 2015 article in the New England Journal of Medicine. Dr. Scott Halstead, a Bethesda, Md., physician who is considered one of the worlds foremost authorities on viruses spread by mosquitoes, remembers reading the results with growing alarm.

In children who had never been exposed to the dengue virus, the vaccine created antibodies that actually appeared to worsen the disease if the youngsters were later infected, he said. Indeed, young children who received the vaccine and later caught dengue were more likely to be hospitalized with severe illness than those who hadnt been vaccinated.

Halstead wrote several articles in scientific journals and even made a video to warn the Philippine government not to distribute the vaccine, called Dengvaxia. Nonetheless, government officials moved forward with the immunization campaign. About a year and a half later, Sanofi announced that it had found evidence that the vaccine did in fact increase the risk of hospitalization in children with no prior exposure, and the program was halted.

The government revoked the license for the vaccine. It also filed criminal charges against Sanofi officials and former and current Philippine health officials over 10 deaths that it said were linked to use of the vaccine. A public backlash against vaccines contributed to major outbreaks of measles in the Philippines.

Halstead fears something similar could happen if a COVID-19 vaccine is rushed.

Theres enormous pressure to come up with a vaccine, said Halstead, 90, who has written an unpublished paper on challenges facing the creation of a COVID-19 vaccine. This, unfortunately, is a complicated virus, and its going to require more care. Thats why its so important to remember history."

Collins, the head of the NIH, said scientists involved in Operation Warp Speed are aware of historical problems with several vaccines. But he said vaccine development has changed so much in recent years that some concerns are unwarranted. For example, he said, there couldnt be another Cutter incident with a COVID-19 vaccine because none of the formulas under serious consideration by federal officials uses a killed virus.

Instead, scientists in the government and at drug companies and academic laboratories are collaborating on a mix of cutting-edge approaches. They include vaccines that rely on genetic material, called messenger RNA, to teach a persons immune system to defend against the coronavirus, and vaccines that use a harmless virus as a Trojan horse to deliver the genetic sequence for the coronavirus into human cells to produce an immune response.

There are more than 120 coronavirus vaccines in development worldwide, and Collins said that if everything goes right, he thinks one could start being rolled out by years end. That would require drug companies to manufacture huge quantities of vaccines before the completion of clinical trials and to discard them if the vaccines dont pass muster, he said.

To make that financially tenable, the government is bankrolling some private efforts. In the case of Moderna, the federal Biomedical Advanced Research and Development Authority pledged up to $483 million in April to help the biotech manufacture a messenger RNA vaccine, before the first phase of the clinical trial was even completed. The government made the commitment even though no mRNA vaccine has ever been approved.

But that doesnt mean youre going to go forward if you see a safety problem or an efficacy problem, Collins said.

With COVID-19 blamed for the deaths of more than 100,000 Americans and a lockdown that is only starting to ease, I dont think anyone wants us to be on Operation Slow Boat," Collins said. We are anxious to get it done, but not to compromise on safety.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com

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Vaccines have saved millions of lives, but history shows missteps can prove deadly - The Boston Globe

New York: Cigarette smoke spurs the lungs to make more of the receptor protein which the novel coronavirus uses to enter human cells, according to a study which suggests that quitting smoking might reduce the risk of a severe coronavirus infection. The findings, published in the journal Developmental Cell, may explain why smokers appear to be particularly vulnerable to severe COVID-19 disease.

"Our results provide a clue as to why smokers who develop COVID-19 tend to have poor clinical outcomes," said study senior author Jason Sheltzer, a cancer geneticist at Cold Spring Harbor Laboratory in the US.

"We found that smoking caused a significant increase in the expression of ACE2, the protein that SARS-CoV-2 uses to enter human cells," Sheltzer said.

According to the scientists, quitting smoking might reduce the risk of a severe coronavirus infection.

However, some require intensive care when the sometimes-fatal virus attacks, the researchers said.

In particular, they said three groups have been significantly more likely than others to develop severe illness -- men, the elderly, and smokers.

Turning to previously published data for possible explanations for these disparities, the scientists assessed if vulnerable groups share some key features related to the human proteins that the coronavirus relies on for infection.

First, they said, they focused on comparing gene activity in the lungs across different ages, between the sexes, and between smokers and nonsmokers.

The scientists said both mice that had been exposed to smoke in a laboratory, and humans who were current smokers had significant upregulation of ACE2.

According to Sheltzer, smokers produced 30-55 per cent more ACE2 than their non-smoking counterparts.

While the researchers found no evidence that age or sex impacts ACE2 levels in the lungs, they said the influence of smoke exposure was surprisingly strong.

However, they said, the change seemed to be temporary.

According to the data, the level of the receptors ACE2 in the lungs of people who had quit smoking was similar to that of non-smokers.

The study noted that the most prolific producers of ACE2 in the airways are mucus-producing cells called goblet cells.

Smoking is known to increase the prevalence of such cells, the scientists said.

"Goblet cells produce mucous to protect the respiratory tract from inhaled irritants. Thus, the increased expression of ACE2 in smokers' lungs could be a byproduct of smoking-induced secretory cell hyperplasia," Sheltzer explained.

However, Sheltzer said other studies on the effects of cigarette smoke have shown mixed results.

"Cigarette smoke contains hundreds of different chemicals. It's possible that certain ingredients like nicotine have a different effect than whole smoke does," he said.

The researchers cautioned that the actual ACE2 protein may be regulated in ways not addressed in the current study.

"One could imagine that having more cells that express ACE2 could make it easier for SARS-CoV-2 to spread in someone's lungs, but there is still a lot more we need to explore," Sheltzer said.

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Quitting smoking might reduce severe coronavirus infection risk: Study - ETHealthworld.com

Much of Taiwans industry is being transformed by the introduction of AI technologies, particularly in the areas of manufacturing and healthcare.

Industry the world over is experiencing some radical changes, propelled by the continued development and application of AI technology across a wide variety of different fields. While in most countries everything from finance and banking to transportation and logistics is being revolutionized by AI, certain areas in Taiwan are undergoing more drastic transformations than others due to the countrys natural advantages in those sectors. These fields include robotics for industrial automation, semiconductor and hardware manufacturing, as well as for healthcare.

In these areas, as well as many others, Taiwan stands to reap the most benefits by integrating innovative software capabilities into its existing hardware infrastructure.

Taiwans economic miracle began with its shift to export-oriented manufacturing in the 1970s, and manufacturing is still a core driver of Taiwans economy today. Furthermore, an increasing number of Taiwanese manufacturers have begun leaning toward industrial automation, boosting demand for smart machinery including intelligent robots in production lines. Both government and industry have seized this opportunity to promote the development of AI-enabled manufacturing capabilities in Taiwan.

The Ministry of Science and Technology (MOST) in 2018 launched the NT$2 billion (US$66.59 million) Robot Makerspace initiative, which established smart robotics hubs in Taichung and Tainan within the Central and Southern Taiwan Science Parks. These centers offer co-working spaces and accelerators for startups to test their solutions.

According to MOST Deputy Minister Hsu Yu-Chin, the central and southern robotics hubs had hosted 71 startups as of the end of last year 43 of them local or international AI-related startups from the ministrys Taiwan Tech Arena program. Startups at the two hubs have been responsible for more than 99 new products or technologies, and in 2019 generated over US$400 million in overseas venture capital and international business collaboration opportunities.

Other industrial automation projects are being carried out by the government-backed Industrial Technology Research Institute (ITRI), including a self-taught robot technology that utilizes deep-reinforcement learning algorithms. Vincent Feng, general director of the Computational Intelligence Technology Center at ITRI, notes that the robotics currently used in manufacturing are semi-automatic and do not have AI capabilities. However, since production in Industry 4.0 can vary from time to time, Feng says, robots should be able to learn to recognize the shape of different objects and materials.

AI is not solely the province of startups and large tech multinationals. A growing number of Taiwans more established technology companies are beginning to explore AI-enabled robotics solutions for their client base as well.

Founded in 1973, Solomon Technology Corp. has expanded its scope of business over the years, going from the initial distribution of power generators and electrical components to the addition of LCDs, semiconductors, and batteries in the 1980s and 1990s. In 2009 the company became the sole Taiwan distributor for Rockwell Automation, the worlds largest industrial automation company. It was at that time, says Solomon Chairman Johnny Chen, that the company began to get interested in what it could do with robots.

I was going to a lot of trade shows, and all of the robots I saw were just doing repetitive tasks, says Chen. We started looking into vision systems and figured that this would be key to solving a lot of the more complex problems you find in production lines.

The company began building up an R&D team to develop its own 3D computer vision system a robots eyes, as Chen puts it. The machine vision is combined with AI deep-learning technology to give the robots the added benefit of a brain the ability to recognize complex objects and patterns.

According to Chen, Solomons decision to delve into AI and machine vision has really begun to pay off. Its systems are now being applied by some of the worlds leading automobile, consumer goods, and e-commerce companies. Solomons 3D vision design has received international recognition as well, winning the prestigious Vision System Design Innovators Award in Chicago last year.

Taiwans push to introduce AI into manufacturing processes is not restricted to robotics. Among other ways in which high-tech operations can benefit from the integration of hardware and software capabilities is predictive maintenance. ITRIs Feng says that knowing when factory equipment is likely to break down or needs to be replaced is especially important in the semiconductor and petrochemical industries, where an unplanned equipment failure can stall the pipeline and cause heavy losses.

Another function that is benefiting from AI integration is defect inspection and classification, ensuring the quality of production. This technology can be applied in the production of semiconductors, printed circuit boards (PCBs), D-RAM, and panels, says Feng.

For example, in the PCB industry, we collected millions of images, then trained the AI model to distinguish between actual defects and false alarms, Feng explains. These false alarms are common with the current system of automatic optical inspection and require human inspection for verification. ITRIs AI inspection model, on the other hand, is much more accurate.

One inspection-equipment vendor for which ITRI developed an algorithm was able to raise the price of its product tenfold and has provided the AI-enabled equipment to major PCB manufacturers, Feng says.

Although the benefits of AI to manufacturing are clear, there is still some hesitancy among Taiwans manufacturers about adopting the technology wholeheartedly in their operations.

Richard DeVries, managing director of Geber Brand Consulting, says that Taiwan is well-positioned to take advantage of AI, but in his experience working with local B2B manufacturers, companies are not always ready to embrace it. He says that this reluctance is generally due to silo issues within an organization, leading to a lack of communication between departments and a persisting top-down hierarchy thats common in Taiwanese companies. There may be impetus to incorporate AI from lower-level employees, but the top executives the decision-makers might be unaware of how it could benefit the company.

We get around this by starting off with a general introduction of how AI in all its forms can apply to B2B manufacturers, DeVries wrote in an emailed response to Taiwan Business TOPICS. You need to show them via statistics, trends, and case studies that this is a huge and growing trend. Using fear of being left out, along with the opportunities AI can bring, often gets buy-in from the top level.

AI for the medical field currently revolves mainly around disease diagnosis and drug screening. It relies on vast amounts of data to learn from and improve its accuracy, something which Taiwan is well-suited for. Since the mid-1990s, the health data of almost every Taiwanese citizen has been collected under the National Health Insurance program from around 30,000 hospitals and clinics and stored in the NHI central database.

Having access to such a massive amount of data is a real boon to developing AI and smart health systems. Of most immediate relevance to AI researchers is the cache of medical image data contained within the NHIs database. This data can be used to train algorithms to detect certain conditions in patients, which doctors and technicians then confirm, increasing the efficiency and reliability of diagnoses.

Taiwans medical image data is currently being used by ITRI to assist Taiwans ophthalmologists in determining whether patients are suffering from diabetic retinopathy, a condition that can cause blindness if left untreated. The algorithm ITRI devised was fed around 10,000 images of retinopathic patients eyes and then installed in a smart funduscope a medical device used to examine the interior structure of the eye.

ITRIs Feng emphasizes the importance of this technology, given the high prevalence of diabetes among Taiwanese 2.45 million people or 10.83% of the population are diabetic. However, most ophthalmologists are based in Taiwans big cities. Patients in more remote locations that have eye conditions like retinopathy are thus often referred to bigger hospitals in the city, a real inconvenience to diabetics. The AI-enabled funduscope thus allows doctors to better serve rural patients.

The Healthcare Lab at privately funded research organization Taiwan AI Labs is also using the NHIs medical image data for its Malaria Diagnostics Project, which uses deep learning to more quickly diagnose the disease by locating the parasite that causes it in images of blood samples. The data is also used for the Labs brain cancer detection software Deepmets, which it launched in partnership with Taipei Veterans General Hospital in 2018.

That same year, AI Labs teamed up with Microsoft to launch a precision medicine platform called TaiGenomics. The platforms algorithm processes and analyzes medical and genetic data which is stored in Microsofts Azure cloud computing platform to help doctors make better diagnoses more efficiently.

An ongoing issue with the NHI data is that while it is available for academic and research purposes, it cannot be accessed by private industry because of Taiwans stringent data protection laws.

The restrictions on data use indicate the governments desire to align with data protection standards from places like Europe and the U.S. and to be a good global citizen, says Stephen Su, vice president and general director of ITRIs Industry, Science and Technology International Strategy Center (ISTI). But the government has recognized the need to make the data more accessible, says Su, who also heads the Office of AI Application Strategy under ISTI.

Still, given the competition Taiwan faces from China and other regional players in the AI realm, the situation now is like running a race thats started before the gun even sounded, Su says. We need to have technology and controls in place so that data can be used in a more transparent way and that its value can be maximized as well.

Joe Yeh, founder of the medical image AI startup aetherAI, says that his company has had to work around the data use restrictions by obtaining institutional review board (IRB) approval to collect data directly from local hospitals. This method is legal but time-consuming, he says

Yeh and the aetherAI team now use the data they collect from individual hospitals in Taiwan to develop AI for digital pathology. While this field has been around for nearly a decade, having the AI diagnostic systems in place to manage the image data and help create reliable prognoses takes a lot of the burden off of pathologists.

AI can be very sensitive, it doesnt get tired, and it trains on a vast amount of data, Yeh says. He notes that in pathology, you can now have double readings, where AI screens once and the pathologist screens a second time. There are indications that Taiwans data regime may become more flexible in the future. According to a March article in local publication Digitimes, NHI Administration Director-General Lee Po-chang has said that the administration is beginning to discuss with life insurance companies the possibility of using NHI data to better tailor plans for their clients.

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Where Taiwan Can Make the Most of AI - Taiwan - Taiwan Business TOPICS

Geneva: The World Health Organization (WHO) and the International Olympic Committee (IOC) on Saturday signed an agreement to work together to promote health through sport and physical activity.

"I am pleased to formalize this longstanding partnership with the International Olympic Committee. WHO works not only to respond to disease but also to help people realize their healthiest lives and this partnership will do exactly that. Physical activity is one of the keys to good health and well-being," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

This collaboration is timely. The current COVID-19 pandemic is particularly affecting people with noncommunicable diseases (NCDs). The agreement has a special focus on preventing NCDs through sport. Physical activity helps lower blood pressure and reduce the risk of hypertension, coronary heart disease, stroke, diabetes, and various types of cancer (including breast cancer and colon cancer).

Other areas of collaboration include working with host countries to ensure the health of athletes, supporters and workers at the games as well as addressing NCD risk factors, including water quality and air pollution. The two institutions will also work to ensure that the games leave a healthy legacy in host countries through enhanced awareness of the value of sport and physical activity.

"Over the last few months in the current crisis, we have all seen how important sport and physical activity are for physical and mental health. Sport can save lives. The IOC calls on the governments of the world to include sport in their post-crisis support programmes because of the important role of sport in the prevention of NCDs, but also of communicable diseases," said IOC president Thomas Bach.

Globally, WHO estimates that 1 in 4 adults is not active enough and more than 80 per cent of the world's adolescent population is insufficiently physically active. The new partnership will bring together the sports and health sectors at international, regional and national levels to reach global goal of increasing physical activity by 15 per cent, as set out in the Global Action Plan on Physical Activity.

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WHO and IOC team up to improve health through sport - ETHealthworld.com

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.

Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

This report contains information on the following:

The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

Key Topics Covered

Part I: Technologies, Ethics & Regulations

Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit https://www.researchandmarkets.com/r/7h12ne

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The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -...

Few would question the benefits of a medical profession which reflects the socio-demographic make-up of New Zealand. Our medical schools are now boosting Mori, Pasifika and rural student numbers but have they got the balance right? MARTIN VAN BEYNEN reports.

Harry* is a bright and social 18-year-old who was always passionate about becoming a doctor. He was brought up in a well-off home by professional parents but family issues meant life was no bed of roses.

He completed the first year health science course at the University of Otago last year with an A+ average grade and also managed a top score in the required University Clinical Aptitude Test (UCAT). He was absolutely gutted and so were his parents when he was not accepted into Otago Medical School.

Incredibly, his academic results were not good enough. His disappointment was not helped by students with far lower grades and poorer UCAT results being accepted under special categories including Mori and Pasifika, rural and low socioeconomic.

Harry, of European descent, was not alone in his disappointment. Other European and Asian students faced similar setbacks. At least one family has threatened legal action.

READ MORE:* She aspired to be a doctor at 10, to 'make a point' that Mori can * We need more diversity in our health system - entrance schemes help* Emails reveal Otago and Auckland's med school meddling * Auckland and Otago medical schools undermine Waikato bid* Record numbers of Maori doctors graduate from med school

Its a touchy subject. Few would disagree that elite professions like medicine should reflect the socio-demographic make-up of the general population. Evidence suggests that doctors who have more things in common with their patients will be more empathetic and have more success in diagnosis and getting patients to follow recommended treatments.

But have the medical schools gone too far in trying to redress the balance by squeezing out a growing number of general students? And have entry requirements become too easy to manipulate?

For a long time the medical school intake from some sections of society, notably Mori and Pasifika, was much lower than their proportion of the population.

Only a decade ago, a mere 7.6 per cent of new domestic medical students at Otago identified as Mori and 2.7 per cent as Pasifika. The ramifications show up in the current medical workforce in which only 3.4 per cent are Mori and 1.8 per cent Pasifika. Their respective proportions of the total population are about 15 per cent and 8 per cent.

However, a big change was seen after more robust affirmative action policies were implemented at medical schools after 2010. By 2016 Mori and Pasifika students entering Otago Medical School had increased by 179 per cent Mori were about 16 per cent of domestic students and Pasifika students counted for 5.6 per cent.

One group, however, showed little improvement. In 2010 only 2.4 per cent of Otago medical students had attended a secondary school with a socioeconomic decile of less than four.

By 2016, the percentage had grown to 4.7 per cent.

Wiremu*, now training to be a general practitioner, was one of those students who benefited from affirmative policies designed to increase Mori in the medical workforce. A product of kohanga reo and a low decile Mori immersion primary school, he had a flair for science and wanted to work with people.

His low decile high school had not prepared him well for the highly competitive intermediate year at Auckland University, but he worked his guts out and was accepted into its medical school.

His life experience in different sections of the community, including gang families, enables him to relate to patients better than a book-smart, nerdy type from a privileged background, he says.

As a junior doctor, he was often able to get through to certain Mori patients just by saying his name.

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Some people cant see the difference between equity and equality," says a junior doctor.

They suddenly realised there was a Mori person on the other side. You just have to see their face when I say Kia Ora Im Wiremu some of them go, True Bro I thought you were Pkeh. In certain circumstances we will have a chat in Mori and obviously that's useful. Then we have a brief introduction period, you get to know the other person. Pronouncing someones name correctly is massive.

He says getting more Mori into medical schools wont fix the inequities in health outcomes but it will help.

Some people cant see the difference between equity and equality. Ive learned so much about why Mori are the way we are today. Sometimes you have to direct more resources to some people for outcomes to be equal.

Some students manipulate the system, but they are a small minority, he says.

For this years intake, Otago had 202 places available for first year students entering from its intermediate year. (Otago does not take first year students from other universities).

Of those, 120 were given to those entering under a raft of categories.

Of those, 58 were Mori, 20 were Pasifika, 1 Mori/Pasifikaand 29 entered through the rural gate. Eleven students went in under the low socio-economic category and one under a new refugee category. That left only 82 general entry places (40 per cent).

As well as the 202 places for first year students, Otago medical school fills another 80 places with graduates. Overall for 2020, Mori and Pasifika make up 32 per cent of students starting at the school, while 14 per cent have rural backgrounds, 4 per centlow socioeconomic, and 1per cent refugee.

Auckland medical school shows a similar pattern. For the 2020 year it had 185 places for first year health science or bio-medicine students. Mori and Pasifika took up 52 places, rural got25, disabled 2, low socioeconomic 5 and refugee1. That left 101 places (55 per cent) for general entry students.

Looking at percentages for the 2020 intake, Mori and Pasifika students took up nearly 40 per cent of the places at Otago for first year health science students and 28.1 per cent of the total places for first year students at Auckland.

At Otago that meant general entry students had to get, as one student put it, ludicrously high grades to be accepted. In fact candidates needed at least a 94 per cent average mark for their seven papers to get an offer.

The father of a European student who missed out on this years intake at Otago despite stellar marks says he can understand why district health boards and central government want the medical workforce to be representative.

Where I have difficultyis reconciling that with students who would make wonderful doctors and have extremely high marks being lost to the medical profession.

The average mark for the sub-category entrants is not held by the university and it was not able to provide it before deadline.

However, sub-category entrants must get a 70 per cent minimum for each paper. Those who achieve an average of at least 70 per cent can be admitted with individual subject marks under 70 per cent so long as the admissions committee is satisfied about their academic ability to complete the programme.

At Otago, a candidates overall UCAT score does not count in the assessment by the admissions committee but general candidates must score in the top 80 per cent of results for verbal reasoning and in the top 90 per cent for situational judgement.

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This could hurt:Medicine does not need society's brightest students, says a top medical educator.

Critics say the low thresholds are farcical because no-one with good enough grades to be a doctor will go below the thresholds. The university says it uses the scores when choosing between candidates who are otherwise very similar.

The thresholds do not apply to Mori and Pasifika candidates. They are assessed by reference to specific material provided by applicants about their engagement with their communities.

In Auckland, admission is based on an interview (25 per cent), first year marks (60 per cent), and the UCAT result (15 per cent).

Otago University cannot say how many Mori and Pasifika students would have met the grades required by successful general applicants in this years intake, but Professor Paul Brunton, Pro-Vice-Chancellor, Health Sciences says if affirmative action had not been undertaken both Mori and Pasifika students would have been significantly under-represented in this years class compared with the make-up of New Zealand society.

Does the medical school have a cap on sub-category students?

Brunton says the Education Act states affirmative action places can only be offered where a relevant category of applicant would otherwise be under-represented in the medical programme.

To date, the number of sub-category students we have been able to admit continues to be well below the needs of the health workforce.

The Government funds 55 rural places at each of the universities of Otago and Auckland, he says.

Medical school applicants at Otago need to meet a number of requirements to be successful under the various subcategories.

The Mori and Pasifika category requires students to verify their ancestry by, for instance, an iwi registration document or, for Pasifika, a community leaders endorsement.

Applicants under the rural category can hail from places such as Helensville and Pukekohe near Auckland, Lincoln and Rangiora on the outskirts of Christchurch and Featherston, Greytown and Martinborough near Wellington. They also include Queenstown Bay, Frankton, Cromwell and Wnaka.

Under the low socioeconomic category, candidates must have attended a decile one to three secondary school during Years 11, 12 and 13. Parental income is not considered.

JOHN KIRK-ANDERSON/STUFF

Some of Jordan Tewhaiti-Smith's relatives - including his dad - are Mongrel Mob members. They were also his biggest supporters while he studied to become a doctor. (Video first published in December 2019)

In order to apply under the refugee sub-category, candidates for admission must have either been granted refugee status in New Zealand, or have parents/primary guardian(s) who have been granted refugee status.

Affirmative action is always controversial. Critics say it breeds resentment, stigmatises those students who avail themselves of the special categories and lowers the standards and prestige of an institution.

One of the objections is that it can give an unfair advantage to privileged students who actually have little in common with the minorities with whom they claim to have some genetic link. In other words, a Mori student from a relatively privileged home could be admitted over a European or Filipino student from a poorer home despite their better marks.

During his first presidential campaign, Barack Obama, said his two daughters who have had a pretty good deal should not benefit from affirmative action, particularly when they were competing with poor white students.

Some claim the system is open to abuseby wealthy students with a distant relative who is Mori orPasifika..

"These kids are attending private schools and are being allowed into medical school without achieving like the others must. It is not achieving the aims of helping Mori, says one parent.

Another parent asked if patients were better served by doctors who were"empathetic and more academic" regardless of ethnicity.

Professor Peter Crampton, whose parents immigrated from England to New Zealand when he was 12, and who worked as a GP in Porirua, near Wellington, is one of the main architects of the Mirror on Society policy at Otago University.

A former dean of the Otago Medical School and now professor of public health in Khatu Centre for Hauora Mori, he doesnt regard the issues around special entry into medical school as highly sensitive.

He says the purpose of the university is to produce a health workforce that meets the needs of society.

The-Southland-Times

Peter Crampton, aprofessor of public health, says medical schoolsselect students "for things we can't teach".

Doctors who belong to a rural or ethnic minority are more likely to serve those communities and provide the care that is not like the care provided by others.

He draws parallels to the dearth of female doctors in the medical workforce in previous decades.

It was thought men do that job very well and although we think of that as quaint and old fashioned, its not that long ago.

Mori doctors treating Mori patients could lead to better outcomes for multiple reasons, both interpersonal and because of the way systems are set up, he says.

He agrees no guarantee exists that students admitted under the sub-categories will go on to work in those areas and says its too early to tell whether the special entry scheme is helping to improve outcomes for Mori and Pacific patients.

We dont put on any of our students, any of them, any sort of moral weight to do a particular thing.

No affirmative system will have perfect rules and perfect compliance, he says. Defining a student's rural credentialssounded simple but coming up with a transparent and fair system was tricky.

He doesnt acceptthat students being admitted under the Mori or Pasifika sub-categories, who look European and have suffered none of the deprivations of low socioeconomic Mori or Pasifika, should not be allowed to take advantage of the easier route into medical school.

Nor does he agree that if Mori or Pasifika patients are to benefit from an affinity with the doctor, the doctor should look a bit like them.

If you are saying it would help if you look Mori I reject your framing entirely. Would it help if you looked gay?

We want the health workforce to broadly reflect the communities being served so that when you come into contact with the health force, whatever that touch point might be, there is some chance that system has been influenced by health professionals who share your world view, your ethnic affiliation or your gender and you meet a health professional who you might identify with and makes you feel at home within that system.

He finds the allegation that European-lookingstudents from well-off homes with slight Mori or Pacific ancestry are rorting the system hard to get a handle on.

You're conjuring up a phenomenon that encapsulates a world view that I would like to deconstruct.

He says Mori and Pacific students have a different socio-economic profile to general entry students although it is true the research in 2016 showed little movement in admitting more students from lower decile schools.

Any system of exclusion or inclusion is going to run into its difficulties at the margins with definitions.Its not perfect or watertight. Does that discredit the system,do we throw out a system because some people might not be eligible? The health workforce needs more Mori-Pacific students. We have not specified if they be rich or poor.

Although Mori and Pasifika students coming through the intermediate year pathway into Otago medical school were exceeding their proportion of the general population, the proportion of those groups in the medical workforce realistically will not catch up not in our lifetimes.

The marks required by general entry students was very high but people needed to remember why are we are doing this.

The high marks phenomenon is an artefact of selection processes. If I ask people, what do you like to see in your doctor? they say good communicator, honesty, compassion, altruism, along those lines. They never say we want them to have had straight As at school and through university.

We can't easily measure what we need to measure. Medicine does not need society's brightest students, it benefits from them but doesn't need them. That is an artefact of career aspirations occurring over decades.

We select people to meet certain characteristics we select them for things we can't teach. It is a demanding and difficult course and it needs people who are bright, capable and highly motivated. That is not the same as saying we need the top academic students. We don't have to have them.

Medical schools were sick of using marks.

He believed the UCAT thresholds were meaningful and helped exclude candidates who could be brilliant lab scientists but no good at face-to-face medicine.

So what would he say to Harry with his tremendous marks and who had his heart set on medicine?

Iunderstand their bitter disappointment and in my counselling I strongly encourage them to explore other options. So many young people base their sense of their identity and ambition on a particular academic pathway and feel quite devastated when that is not achieved. The world is full of amazing career opportunities for the academically capable."

Does he understand their resentment?

Thats where I come back to the policy and its intention. The policies are clear. To me personally and many colleagues in the university it's completely unacceptable that we have a health workforce devoid of Mori. We are rectifying that situation. The problem is that high marks have become the passport and because I've got high marks I should be a doctor.

*Notreal names.

Link:
Medical School: Who gets in and why - Stuff.co.nz

Founder,Drug Salvation Foundation,WilsonIghodalo, who alsodoubles as theNational Coordinator, NDLEA Celebrity Drug Free Club Nigeria,is also a United Nations Office on Drugs and Crime Master Trainer on Sensitisation on Drug and Drug Prevention, Treatment and Care. Known for his passion in addressing substance abuse, Ighodalo in this interview withChiemelie Ezeobi,stronglycanvassed for public health approach to tackle substance abuse in Nigeria

What is your take on the state of the health sector now?

At present the COVID-19 pandemic and how it is being addressed, should be a wakeup call to Nigeria. Public health approachis the single most important goal. Public health promotes and protects the health of people and the communities where they live, learn, work and play.

What is your take on substance abuse as a public health challenge?

There is need to reducesubstance abuse to protect the health, safety, and quality of life for all, especially children. Millions of Nigerians struggle with a drug or alcohol problem. Almost 95 per cent of people with substance use problems are considered unaware of their problem. Few of those who recognise their problem, many have made an unsuccessful effort to obtain treatment. These estimates highlight the importance of increasing prevention efforts and improving access to treatment for substance abuse and co-occurring disorders.

What are its impact on lives?

Substance abuse has a major impact on individuals, families, and communities. The effects of substance abuse are cumulative, significantly contributing to costly social, physical, mental, and public health problems. These problems include: teenage pregnancy, Human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), other sexually transmitted diseases (STDs), domestic violence, child abuse, motor vehicle crashes, physical fights, crime, Homicide and suicide.

What was the impact of COVID-19 on children that are addicted to drugs?

Due to the lock down because of COVID-19, some children could no longer have access to drugs and the withdrawal syndromes are becoming more evident and some parents are just beginning to realise that their kids are using drugs. This has made a lot of them panic. I hope they seek for help to allay their fears.

So what is substance abuse?

Substance abuse refers to a set of related conditions associated with the consumption of mind- and behaviour-altering substances that have negative behavioral and health outcomes. Social attitudes and political and legal responses to the consumption of alcohol and illicit drugs make substance abuse one of the most complex public health issues. In addition to the considerable health implications, substance abuse has been a flash-point in the criminal justice system and a major focal point in discussions about social values: people argue over whether substance abuse is a disease with genetic and biological foundations or a matter of personal choice.

Advances in research have led to the development of evidence-based strategies to effectively address substance abuse. Improvements in brain-imaging technologies and the development of medications that assist in treatment have gradually shifted the research communitys perspective on substance abuse. There is now a deeper understanding of substance abuse as a disorder that develops in adolescence and, for some individuals, will develop into a chronic illness that will require lifelong monitoring and care.

Improved evaluation of community-level prevention has enhanced researchers understanding of environmental and social factors that contribute to the initiation and abuse of alcohol and illicit drugs, leading to a more sophisticated understanding of how to implement evidence-based strategies in specific social and cultural settings.

A stronger emphasis on evaluation has expanded evidence-based practices for drug and alcohol treatment. Improvements have focused on the development of better clinical interventions through research and increasing the skills and qualifications of treatment providers.

What are the emerging issues in substance abuse?

In recent years, the impact of substance and alcohol abuse has been notable across several areas, including the following: Adolescent abuse of prescription (Over The Counter OTC) drugs has continued to rise over the past five years. The recent survey found high rates of nonmedical use of the prescription pain relievers Tramadol and Codeine etc. It is believed that two factors have led to the increase in abuse. First, the availability of prescription drugs is increasing from many sources, including the family medicine cabinet, the Internet, and doctors. Second, many adolescents believe that prescription drugs are safer to take than street drugs.

In addition, as the federal governmentthrough Presidential Advisory Committee for the Elimination of Drug Abuse, (PACEDA) headed by Retired Brigadier-General Buba Marwa, should begin to implement health reform legislation, to focus attention on providing services for individuals with mental illness and substance use disorders, including new opportunities for access to and coverage of treatment and prevention services.

What is your foundation about?

The Drug Salvation Foundation is a non-government and Non-Profit

Organisation aimed at promoting the quality of public health in the society by leading efforts in the prevention, education, advocacy and care of

substance abuse disorders etc. The organisation is based in Lagos and have driven drug abuse interventions across the country, organising

trainings and prevention campaigns on substance abuse. It has organised various activities in a bid to raise awareness on drug abuse in the society. We have driven drug abuse interventions across the country, through quiz, debates, organising trainings, conferences, charity walk, courtesy visits, workshops, annual lectures and prevention campaigns on substance abuse.

We have reputable personality as board of trustees and founding fathers of this prestigious organisation in the person of Pastor ItuahIghodalo, who is the Chairman of The Drug Salvation Foundation. He is the Managing Partner at SIAO (a firm of CharteredAccountants and Management Consultants) and Senior Pastor Trinity House Church. We also have Otunba O.A. Lawal (Honorary Consul). He is at present the honorary Consul of Malta in Nigeria and the President of the Nigerian-Maltese Business Council.

Putting it in context, we are reaching out through advocacy campaign that seeks to address the current negative perception about people with drug related issues, by promoting evidence based approach which considers drug use as a public health, human rights and development agenda. It

rest on the fact that existing (criminalisation and discrimination) response has failed to effectively address the drug challenge in our society.

What we adopted in The Drug Salvation Foundation as best practice, we do in-house training for our personnel and clients. As part of the efforts to build capacities of staff and associates for optimum performance. All humans are born geniuses. The onus is on all of us to discover, nurture and develop it for the betterment of the society. The need therefore for training and retraining for an enhanced performance cannot be over emphasised.

What drives you in pushing issues against drug abuse in Nigeria?

Drug abuse in Nigeria is a major cause for concern, especially since children as young as eleven years old, are abusing drugs. That informed part of my passion to champion the cause and children are the future of tomorrow, focusing on prevention and promotion of healthy lifestyle against substance abuse now became my ways of touching lives. I found The Drug Salvation Foundation as a platform to share information and ideasabout the problem of substance abuse. This include sharing ideas on how to communicate the message of zero tolerance to drug use. It also highlights the fact that substance abuse interventions are aimed at saving lives, preserving familiesand building stronger communities.

A number of investigations show that Nigeria is experiencing a sharp increase in young people abusing substances like drugs and

alcohol. Many of the patients admitted to rehabilitation and treatment centres for substance abuse are children as young as 11 to 16 years old.

Drug and alcohol abuse at a young age is often the result of peer pressure, which starts at school. In addition, during the school holidays, children are often at home alone because their parents have to work. Children, especially teenagers, get bored and start hangingaround with the wrong group of people, bad influencers. They are then pressurised into trying new drugs, smoking or drinking alcohol, because they want to fit in.

Once children start using substances, they often become problematic drug users. To feed their addictions as they become involved in criminal activities as they try to get money to buy drugs. This can become a continuous cycle of conflict with the law. As part of our integrated approach towardspromoting a drug free society, our NGO also looks at ways to target schools and the inner city youths.

How many years have you championed this cause?

My sojourn started as a media consultant to National Drug Law Enforcement Agency NDLEA in 2004. I am a member of Advertising Practitioners Council of Nigeria(APCON), thus Iam an advertising practitioner.

What are the major challenges you have battled in the course of your journey in fighting drug abuse?

Funding and society approach to drug users. Funding from Corporate organisations and High-net-worth individuals (HNWI). We are still hoping corporate bodies and individuals should fund drug abuse awareness campaign and funds improving thecapacity of civil society organisations, so that we can properly take the awareness campaign to schools, inner cities youth, communities and parents, so that parents and communities leaders can properly educate their walls and youths who are more vulnerable to drug abuse. There are so many benefits for corporate sponsorship, but the major one is a Cause Related Marketing for their brand, society will see the organisation as worthy company that contribute positively to the society, sincerely, it will raise their profit. Also it is time now, organisations see drug abuse as public health issues. Substance abuse constitutes socioeconomic and cultural threat in our society today. The time has come for corporate organisations to fund drug abuse awareness campaign, as there corporate social responsibility to the society. We can not all fold our hands and allow the society to decay.

Why public health-based approach?

The society should start seeing drug abuse problems as public health issues and it need public health centred approach. Stressing that drug abuse is not a personalchoice rather a public health issue,substance abuse is a call for a public health-based approach to addressing and discussing the importance of building awareness of substance

abuse as a public health problem. Public health is the science of preventing disease and injury and promoting and protecting the health of populations and communities.

What about punitivedrug laws in Nigeria?

As part of ongoing advocacy against abuse and stigimatisation, as CSOs working on drugs, we are also championingdialogue with stakeholders that brings together key state institutions in charge of theenforcement of the drug legislation, civil society activist, public health workers, human rights

activist, media, lawyers and more importantly the most affected population to change the narrative about drug policy in Nigeria.

Continued here:
Wilson Ighodalo: Addressing Substance Abuse as a Public Health Problem - THISDAY Newspapers

The first installment of a documentary called Plandemic stormed through social media this week, promising viewers on its website that the film will expose the scientific and political elite who run the scam that is our global health system. The video appeared across platforms, with individual uploads each garnering hundreds of thousands of views.

But the viral video, running nearly 26 minutes, weaves a grand conspiracy theory by using a host of false and misleading claims about the novel coronavirus pandemic andits origins, vaccines, treatments for COVID-19, and more.

The video is largely an interview with Judy Mikovits, a former chronic fatigue researcher who has lobbed a number of accusations against National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci. Mikovits was an author on a controversial 2009 study linking a retrovirus to chronic fatigue syndrome that was published in the journal Science, and then retracted in late 2011 after labs were unable to replicate the results and other issues were brought to light.

That same year, in September 2011, Mikovits was fired from her position as research director at the Whittemore Peterson Institute in Nevada and arrested two months later after the institute alleged she stole a laptop, flash drives and other property with institute information. While Mikovits claims in the documentary that she was held in jail despite being charged with nothing, a criminal complaint from November 2011 shows she was charged with two felonies related to the stolen property. The charges were later dropped.

What followed was a years-long legal battle in which Whittemore won a civil judgment against Mikovits; Mikovits filed for bankruptcy; and Mikovits alleged that Whittemore defrauded the government by misusing federally funded research materials. The latter case was dismissed this year.

Mikovits recently co-authored a book with self-described anti-vaxxerKent Heckenlively, with a forward by vaccine skeptic Robert Kennedy Jr., and has spoken at events aimed at discrediting vaccines.

In the video, she claims, And they will kill millions as they already have with their vaccines. Its unclear what vaccines shes referring to, but vaccines have been credited with saving millions of lives. For instance, according to one estimate by researchers with the Centers for Disease Control and Prevention and the World Health Organization, the measles vaccine has saved more than 20 million lives across the globe from 2000 to 2016 alone.

In the sections below, we break down eight of the false, misleading and unfounded claims aired in Plandemic.

The first part of the video focuses largely on two sweeping, but unrelated, accusations against Fauci, who also has been a fixture at the White House briefings on COVID-19.

Without offering any evidence, the video claims that Fauci was part of a cover-up and that he worked with other doctors to take credit and make money on the AIDS epidemic.

Filmmaker Mikki Willis sets the tone for this section of the video, saying to Mikovits, So Anthony Fauci, the man who is heading the pandemic task force, was involved in a cover-up. Willis, a former model, has a large following on YouTube, where he has previously claimed the novel coronavirus was intentionally released.

He directed the cover-up, Mikovits says. And, in fact, everybody else was paid off, and paid off big time.

But at no point in the video does anyone explain what Fauci supposedly covered up.

We asked Mikovits in a phone interview to explain. She said it was a reference to her 2009research paperthat was laterretracted. Mikovits holds Fauci responsible and claims it was part of a cover-up on the part of the medical establishment to keep hidden her research linking a mouse retrovirus to chronic fatigue syndrome. In the years since the research was first published, Mikovits has expanded its reach, suggesting that it could apply also to prostate cancer, lymphoma, and autism.

The NIAID funded Mikovits initial research related to chronic fatigue syndrome, and, after she was fired, another researcher at Whittemore was awarded the remaining grant money. But there is no evidence that Fauci, personally, had anything to do with it. And the journal that published the paper made no mention of Fauci in its retraction. Rather, it explained it was fully retracting the paper because the results couldnt be replicated, even in the same lab, and there is evidence of poor quality control in a number of specific experiments in the Report.

As for the claim about the AIDS epidemic,that goes back much further. In the early 1980s, Mikovits was working as a technician at the National Cancer Institute. She claimsthat the lab she was in had identified the HIV virus from blood and saliva samples and prepared a paper detailing those findings that was slated for publication.

But, she says in the video, referencing one of the pioneers of AIDS research, Dr. Robert Gallo,Fauci holds up the paper for several months, while Robert Gallo writes his own paper and takes all the credit.

Mikovits could not provide the name of her labs paper or the journal that was going to publish it when we spoke to her, so we couldnt check on that. But heres what we do know about the timeline for AIDS research in the early 1980s:

1981 The Centers for Disease Control and Prevention published an article in its Morbidity and Mortality Weekly Report describing a rare lung infection in five young gay men in Los Angeles. Fauci would later recall seeing that article, saying in a 2011 interview, I remember putting the issue to the side of my desk, thinking, Wow, what a bizarre curiosity. One month later, in July, a second MMWR report came to my desk, and this time, an additional 26 men had it, again all gay, all seemingly healthy, and not only in LA, but now also in San Francisco and New York City. I remember reading it very clearly. It was the first time in my medical career I actually got goose pimples. I knew something was very wrong. It changed the direction of my career.

1982 The CDC used the term AIDS, Acquired Immune Deficiency Syndrome, for the first time.

1983 A group of French researchers identified the virus now known as HIV. Twenty-five years later, Franoise Barr-Sinoussi and Luc Montagnier were awarded the Nobel Prize for that discovery.

1984 A team led by Gallo at the National Cancer Institute published research showing that HIV causes AIDS.

Beyond the unsupported claim that Fauci who didnt become the director of NIAID until 1984 stymied early AIDS research at the National Cancer Institute, Mikovits also claims that he has profited from the epidemic.

Referring vaguely to patents, Mikovits says in the video that Fauci was working with other researchers to take credit and make money on the AIDS epidemic. Its true that Faucis name appears on at least six patents related to AIDS research. But its less clear how much he has profited from them. In 2005, the Health and Human Services Department was criticized for not disclosing how much government scientists were collecting from patent royalties. At the time, Fauci expressed concern over the potential for the appearance of a conflict of interest and said that he donated all of his royalty money to charity.

Mikovits makes a claim that numerous scientists have refuted: that the novel coronavirus was manipulated in a laboratory and is not naturally occurring.

So its very clear this virus was manipulated, these, this family of viruses was manipulated and studied in a laboratory where the animals were taken into the laboratory, she says in the video. And this is what was released, whether deliberate or not, that cannot be naturally occurring. Somebody didnt go to a market, get a bat. The virus didnt jump directly to humans. Thats not how it works. Thats accelerated viral evolution. If it was a natural occurrence, it would take it up to 800 years to occur. This occurred from SARS-1 within a decade. That is not naturally occurring.

The exact origin of the coronavirus is not known, but scientists have said the genetic features of SARS-CoV-2 indicate it was neither created in a lab nor manipulated.

Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus, said an article published in Nature Medicine in March. Instead, the authors said its plausible that the coronavirus originated in one of two ways: natural selection in an animal host before zoonotic transfer, which refers to the spread of disease from animals to humans, or natural selection in humans following zoonotic transfer.

The authors said the possibility of an inadvertent laboratory release of SARS-CoV-2 cannot be ruled out, but they do not believe that any type of laboratory-based scenario is plausible because they had observed all notable SARS-CoV-2 features in related coronaviruses in nature.

In a statement in April, University of Sydney professor Edward Holmes, who was involved in mapping the genome of the coronavirus that causes COVID-19, likewise said: Coronaviruses like SARS-CoV-2 are commonly found in wildlife species and frequently jump to new hosts. This is also the most likely explanation for the origin of SARS-CoV-2.

Holmes said there is unfounded speculation that a bat coronavirus named RaTG13, which was being kept at the Wuhan Institute of Virology, was the origin of the new coronavirus. But, he explained, that is not the case, for several reasons.

In summary, the abundance, diversity and evolution of coronaviruses in wildlife strongly suggests that this virus is of natural origin, Holmes said. He added that more sampling of other animals is needed to resolve the exact origins of SARS-CoV-2.

Mikovits also may give viewers a false impression when she says the novel coronavirus occurred from SARS-1, which is a different coronavirus that caused a global outbreak in 2003.

SARS-CoV, or severe acute respiratory syndrome, is similar but distinct from SARS-CoV-2. The viruses share about 79% of the same genetic make-up, but SARS-CoV-2 is even more closely related (96%) to the bat coronavirus from which Holmes has said SARS-CoV-2 wasnt derived.

Weve already written about a bogus analysis that suggested the new coronavirus could have leaked from a Chinese lab because a portion of its genome is similar to part of a viral vector that was used in previous research on SARS.

Kristian Andersen, the director of infectious disease genomics at the Scripps Research Translational Institute, told us in an email that analysis was completely wrong.

Also on the issue of the Wuhan lab, the video shows a clip claiming that $3.7 million flowed from the National Institutes of Health here in the U.S. to the Wuhan lab in China and that NIAID had already been conducting experiments with the Wuhan lab in the past in regard to coronavirus.

Thats misleading.

The project referenced, as other fact-checkers have previously reported, is actually funding from NIAID to EcoHealth Alliance, a U.S.-based nonprofit that researches emerging infectious diseases. The project was done to examine the risk of future coronavirus (CoV) emergence from wildlife using in-depth field investigations across the human-wildlife interface in China, in particular the risk posed by bats, according to a 2014 description.

NIH records show the project was awarded nearly $3.4 million altogether. Most of the funding was through a five-year grant awarded in 2014, Robert Kessler, an EcoHealth spokesman, said in an email to us. The group was renewed for a second five-year grant in 2019 and received $292,161 but NIH recently terminated the grant.

Of that money, only $600,000 (from the first grant) was given to the Wuhan Institute of Virology, Kessler said. The Wuhan lab was a collaborator that was pre-approved by NIH and the State Department, he added, and one that researchers used to conduct genetic analyses of the viruses.

In each of nearly 30 countries around the world where we work, we collaborate with local institutions, all of which are pre-approved by our federal funders, EcoHealth said in an April 28 statement about the terminated funding. Its been EcoHealth Alliances position for the past 15 years that coronaviruses present a clear and immediate threat to our safety. That seems clearer now than ever before.

The group said its research aimed to analyze the risk of coronavirus emergence and help in designing vaccines and drugs to protect us from COVID-19 and other coronavirus threats. In fact, genetic sequences of two bat coronaviruses that we discovered with this grant have been used as lab tools to test the breakthrough antiviral drug Remdesivir.

So its incorrect, and also lacks context, to claim NIAID gave $3.7 million to the Wuhan lab.

Mikovits falsely claims that if youve ever had a flu vaccine, you were injected with coronaviruses.

Shes wrong, Dr. Paul A. Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia, told us in a phone interview. Thats not true.

This person doesnt know what she is talking about, Dr. Lee Riley, professor and chair of the Division of Infectious Disease and Vaccinology at the University of California, Berkeley School of Public Health, told us in an email, adding, I think this person is just seeking publicity.

In an interview, we asked Mikovits what support she had for the claim, and she didnt provide any. She only said that flu vaccines are cultured in chicken eggs and dog kidney cells, and those animals have coronaviruses. Its an extreme leap to then claim animal strains of coronaviruses end up in vaccines tested and approved for people. Mikovits further said she attributes the spread of the novel coronavirus worldwide at least in part to the use of the flu vaccine.

As weve explained before, coronaviruses are a diverse family of viruses, and some, such as canine coronavirus, infect animals. Those arent the same as SARS-CoV-2, the coronavirus that causes COVID-19.

As for influenza vaccines, most are made using hens eggs, Offit explained, and about 10% of vaccines in the U.S. are cell-culture vaccines, which use mammalian cells instead of eggs. Specifically, the process uses Madin-Darby Canine Kidney, or MDCK, cells.

These lines have been around for a long time, Offit said. This is a well-tested cell line that does not contain coronavirus and would never be allowed to.

On its website, the Centers for Disease Control and Prevention has more information on how egg-based and cell-based influenza vaccines are manufactured. A cell-based method that also used eggs at the beginning of the process received Food and Drug Administration approval in 2012, and a fully cell-based process got FDA approval in 2016.

The CDC notes that once vaccines are manufactured, FDA tests and approves the vaccines prior to release and shipment.

This cell-based technology has been used in other U.S. vaccines, including vaccines for rotavirus, polio, smallpox, hepatitis, rubella and chickenpox, the CDC says.

Mikovits also repeats the unsubstantiated claim that the flu vaccines increase the odds by 36% of getting COVID-19, which weve previously covered.

Experts say that there has been no study linking the flu shot to elevated risk for the novel coronavirus. The military study cited by Mikovits involved four types of seasonal coronaviruses thatcausecommon colds, not SARS-CoV-2.

More than that, the results in the study that indicate a flu-vaccinated person had an increased likelihood of testing positive for a seasonal coronavirus do not appear to be adjusted for age groups or seasons. Those factors could affect someones chances of getting a specific virus, regardless of whether or not theyve been vaccinated for the flu.

Multiple scientists have pointed out the same issue in other fact-checks, too, and have debunked the erroneous suggestion that the study looked at SARS-CoV-2.

The Military Health System told us in a statement that the study does not show or suggest that influenza vaccination predisposes in any way, the potential for infection with the more severe forms of coronavirus, such as COVID-19. MHS further said it remains essential for people to obtain the seasonal flu shot each year as it becomes available.

The video makes the unsubstantiated claim that the antimalarial drug hydroxychloroquine is the most effective medication to treat COVID-19, citing a survey of doctors.

Shortly after that, Mikovits says hydroxychloroquine is effective against these families of viruses, referring to the family of coronaviruses, such as COVID-19, but they keep it from the people.

We have covered this ground before when President Donald Trump encouraged the off-label use of chloroquineand its derivativehydroxychloroquine for treatment of COVID-19 patients. Both drugs are used to treat malaria, lupus and rheumatoid arthritis.

But there is only limited evidence that hydroxychloroquine is effective for COVID-19, and it carries potential health risks.

The National Institutes of Health says there is insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19.

Despite insufficient clinical data, the Food and Drug Administration issued an emergency use authorization, or EUA, order on March 28 that allowed for the drugs to be used as a treatment for some hospitalized COVID-19 patients.

A little less than a month later, the FDA issueda warning against using hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. The warning came a few days after astudyfoundthat patients at Veterans Health Administration medical centers treated with hydroxychloroquine had an increased mortality risk compared with those that were not treated with the drug.

In the video, Mikovits says, The AMA was saying doctors will lose their license if they use hydroxychloroquine, the anti-malarial drug thats been on the list of essential medicine worldwide for 70 years. Dr. Fauci calls that anecdotal. Its not storytelling if we have thousands of pages of data saying its effective against these families of viruses. This is essential medicine and they keep it from the people.

Its not true that the American Medical Association told doctors they will lose their license if they use hydroxychloroquine for COVID-19. The AMA issued a statement saying it opposed purchasing excessive amounts of chloroquine or hydroxychloroquine for possible COVID-19 treatment. But it also said, Novel off-label use of FDA-approved medications is a matter for the physicians or other prescribers professional judgment.

As for hydroxychloroquines effectiveness against coronaviruses, we have written that at least two studies show that it has antiviral activity against the novel coronavirus in cells grown in the lab. But there is only anecdotal evidence that the drug works in people.

Trump cited in a tweet the results of a small clinical trial in France, but the International Society of Antimicrobial Chemotherapy, which publishes the journal in which the study appeared, later issued a statement that said the article does not meet the Societys expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.

We cover this more extensively in our story Trump Hypes Potential COVID-19 Drugs, But Evidence So Far Is Slim.

In attacking public health measures taken to address the pandemic in the U.S., Mikovits wrongly suggests that using masks could lead to people infecting themselves with their own breath. Wearing the mask literally activates your own virus, Mikovits said. Youre getting sick from your own reactivated coronavirus expressions and if it happens to be SARS-CoV-2, then youve got a big problem.

Experts were perplexed by what she meant and said the implication that simply breathing through a mask could lead to self-infection doesnt square with science.

Linsey Marr, a professor of civil and environmental engineering at Virginia Tech who studies airborne disease transmission, told us: If youre shedding (breathing out) virus, then youre already infected. Even without a mask, infected people who are shedding virus probably rebreathe some of their own viruses, but there are already billions times more viruses in your body. Hopefully, the mask is protecting other people from your exhalations.

And Lisa Brosseau, an expert on respiratory protection and infectious diseases and a certified industrial hygienist, said in an email that viruses are not activated by anything, as Mikovits suggests.

Viruses instead require living cells in order to replicate, but their viability or ability to replicate isnt affected whether someone is wearing a mask or not, said Brosseau, a former professor at the University of Illinois at Chicago. If anything, viruses in the environment can be rendered non-viable by exposure to certain temperature and relative humidity conditions.

There is nothing magical about our breath that activates or reactivates a virus, Brosseau said.

As weve previously written, while there is little research on cloth masks, the hope is that they can help prevent individuals, even those who do not feel sick, from unknowingly spreading COVID-19 to others. Brosseau said people should frequently wash cloth masks, though, and stressed that masks are not a substitute for social distancing. The CDC notesthe same.

Mikovits says in the video: In 1999, I was working in Fort Detrick and my job was to teach Ebola how to infect human cells without killing them. Ebola couldnt infect human cells until we took it in the laboratories and taught them.

Its not clear what she meant by that, and she didnt explain when we asked about her claim.

But the suggestion that Ebola, which includes six species of ebolaviruses, didnt infect people until 1999, or later, is false.

The first two species, Zaire ebolavirus and Sudan ebolavirus, were discovered after outbreaks in 1976 in Central Africa. Combined, those two viruses, which scientists believe may have come from bats or nonhuman primates (such as chimpanzees, apes, monkeys, etc.), killed about 430 people that year, according to the CDC.

Zaire ebolavirus which is also linked to the largest Ebola outbreak which began in West Africa in 2014 is said to have initially spread in 1976 through the use of contaminated needles and syringes at a hospital in the village where the first infected person was treated. And the Sudan ebolavirus is believed to have started with workers in a cotton factory.

In fact, the CDC says four of the six species of ebolavirus Zaire ebolavirus, Sudan ebolavirus, Ta Forest ebolavirus (formerly Cte dIvoire ebolavirus) and Bundibugyo ebolavirus are known to cause disease in people. And three of the four species were discovered prior to 1999.

A fifth species, Reston ebolavirus, was first discovered in 1989 in research monkeys imported into the U.S. from the Philippines. That species is known to cause disease in nonhuman primates and pigs, but not in people, the CDC says. There have been cases in which individuals developed Reston ebolavirus antibodies, but did not experience symptoms.

The sixth species, Bombali ebolavirus, was discovered in 2018 in a bat in Sierra Leone. It also is not known to infect humans.

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