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Fine-Tuning Treatments for COVID-19 – American Council on Science and Health

By Stem Cell Doctors

President Trumps COVID-19 recovery has thrust into the spotlight the possibilities of novel, experimental therapies for this potentially deadly disease. During his stay at Walter Reed National Military Medical Center, he was treated with at least three drugs that have since received substantial attention in the media: the anti-viral remdesivir, the glucocorticoid steroid dexamethasone, and the monoclonal antibody cocktail REGN-COV2.

While evidence suggests these drugs may be effective (and remdesivir just received full marketing approval from the FDA), there are other potential game-changers that have not yet attracted much attention; in fact, almost 2,000 clinical trials of drugs and vaccines (mostly the former) have been registered on the federal governments database. Many of these focus on individuals immune system, either by eliciting an immune response (vaccines) or modulating it, in order that a response is not deleterious.

We Need Vaccines and Therapeutics

While much attention has been paid to the roughlyfive dozen potential vaccine candidatesfor COVID-19 currently in development, even the approval of one or more will not be the end of the COVID-19 pandemic saga. First of all, no vaccine is 100% effective, able to prevent infection, or even symptoms, in all recipients. (The overall average for flu vaccines is 40-60%, while for the first shingles vaccine, it was about 70%).

But as I discussed in a recent article, even an excellent vaccine is no good if no one takes it, and surveys have found significant resistance. A Kaiser Family Foundationpollpublished last month found that only about 42% of Americans would opt for a free COVID-19 vaccination before the presidential election.A similar result emerged from a more recentsurveyby Morning Consult, which found that only 38% would get a coronavirus vaccine if one became available. Those data are in line with the poor uptake of other vaccines intended for adults.

If the poll numbers hold up, even after vaccines are available, we could see continuing high levels of COVID-19 infections, with sporadic surges above baseline. It has been estimated that we will need immunity in roughly70% of the population, through either natural infection or vaccine administration, in order to achieve herd immunity, or community immunity, which occurs when a sufficiently large portion of a community (the herd) becomes immune to a disease that the spread of disease from person to person becomes unlikely.That protects the whole community not just those who are immune.Clearly, we will never even approach that, if a significant fraction of the population rejects the vaccine. Thus, there will be an ongoing need to wear masks, for social distancing, avoidance of crowds indoors, and also for better drug treatments for people who do become infected.

The Immune Response: Too Little or Too Much?

The immune system wanes as people age, resulting in a diminished ability to fight off infections or to mount a vigorous immune response to vaccines hence, the high mortality rate in patients with COVID-19 and the special, higher-dose versions of flu vaccine for seniors. However, in many patients with severe COVID-19, the bodys own exaggerated immune response can be just as damaging if not more so than the virus itself. It can take several forms, including injury to the endothelium (i.e., the cells lining the inside of blood vessels), cytokine storm (the uncontrolled release of proinflammatory proteins, as part of the immune response), or excessive coagulation. These can lead to life-threatening acute respiratory distress syndrome (ARDS) and multi-organ damage. Studies conducted earlier this year showed that the nucleocapsid, or N-protein, of SARS-CoV-2 is involved in activating the lectin pathway, an essential part of the complement system, which provides an organisms effective defense against invading pathogens. The lectin pathway itself is also a proteolytic cascade of molecular events that gives rise to, among other things, the adaptive immune response.

More specifically, a group of Chinese researchers found in studies in mice that the N-proteins of SARS-CoV-2 and other highly pathogenic coronaviruses bind to MASP-2, the key serine protease in the lectin pathway of complement activation, which results in aberrant complement activation and severe inflammatory lung injury. This N-protein-induced complement hyper-activation was also observed in COVID-19 human patients, and a promising suppressive effect was observed when the deteriorating patients were treated with anti-C5a monoclonal antibody. Therefore, they concluded that, Complement suppression may represent a common therapeutic approach for pneumonia induced by these highly pathogenic coronaviruses.

A promising drug candidate that targets this pathway is a monoclonal antibody called narsoplimab that blocks the MASP-2 enzyme and inhibits activation of the lectin pathway. By blocking the activation of this part of the bodys immune system, narsoplimab should dampen the impact of the overactive immune response and prevent a dangerous cascade of complications including coagulation and blood clots, while leaving the anti-infection activity of the adaptive immune response intact.

Narsoplimab is currently being evaluated by the FDA to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and is in Phase 3 clinical trials in IgA nephropathy and atypical hemolytic uremic syndrome. FDA has granted the drug breakthrough therapy designation for both HSCT-TMA and IgA nephropathy. Since injury to endothelial cells (the cells that line blood vessels) is central to the pathophysiology of both COVID-19 infection and HSCT-TMA, the drugs potential to help treat COVID-19 patients is promising. A peer-reviewed studyconducted by Italian and American doctors in Bergamo, Italy an early COVID-19 hotspot suggests that narsoplimab could be an effective treatment for critically ill COVID-19 patients with ARDS and multi-organ disease in patients requiring mechanical ventilation. After two to four weeks of treatment, all six patients in the study recovered and were discharged from the hospital after showing a sustained reduction in all assessed markers of endothelial damage, inflammation, and coagulation. Further, researchers reported no drug-related adverse reactions from any patients in the study and also suggested that two of the patients who had massive bilateral pulmonary thromboses may have benefited from narsoplimabs anticoagulant effects.

Due to the emergent nature of narsoplimabs use in Bergamo, the administration of the drug was not performed as part of a formal, prospective, controlled clinical trial, and the physicians were only able to compare the patients to a control group retrospectively, with the controls showing mortality in excess of 50%. The growing body of literature on the need to stop the cascade of complement activation, coagulation, and inflammation suggests the need for further research on this promising approach to COVID-19, especially in sicker patients in jeopardy of, or experiencing, cytokine storm.

We might, indeed, have to live with COVID-19 infections at some level in the community for the foreseeable future, but it should be with as few hospitalizations and deaths as possible. Therefore, moving forward, the research community should pursue every promising drug and vaccine candidate.

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Fine-Tuning Treatments for COVID-19 - American Council on Science and Health

Aborted girl fetus kidneys made Trumps CoV meds. As SARS2 is unfettered in America, this needs thought – Feminine-Perspective Magazine (FPMag)

By Stem Cell Doctors

In order to produce the medication that maybe saved Donald Trumps life, an unborn baby girl died in an abortion. This fetus had to be one that had kidneys.

Not much is said about Trumps unapproved monoclonal antibody cocktail perhaps because in mid-August of this year, more than a month before Trump took sick with COVID-19, Trump kyboshed fetal tissue research.

The Trump Administration-appointed (Feb. 2020) Human Fetal Tissue Research Ethics Advisory Board of 15 persons, mostly anti-abortionists, banned just about everything that used fetal cells, in any quantum, from being used in research projects. Some fourteen proposals out of fifteen were quashed.

Editorial science comment, by Micheal John

Click to enlarge. Immunofluorescent Human Embryonic Kidney 293 cells. Phospho-Histone H3 (yellow), phalloidin (green), nuclei (red). Photo Credit: Iznewton, CC BY-SA 4.0,

The medical research community was nearly apoplectic claiming the Human Fetal Tissue Research Ethics Advisory Board is bogus with absolutely no proper scientific credentials to make such edicts.

US Health Secretary Alex Azar must take the final call, however none of the sources FPMag spoke with had any doubt of the Human Fetal Tissue Research Ethics Advisory Board getting its decisions approved.

Anti-abortion is a fundamental tenet of the Republican Party. But Trump is alive perhaps because of research that initially used fetal tissue.

Trump is a con artist, a grifter, a liar. People who dont realize that are vulnerable to falling into the category of mark, sucker, or in Trumps own words, one of the losers who falls for his cons. Consumer advocates call this type of person Trump calls losers as the credulous citizen. They are vulnerable to things like false advertising and bogus products. Its a challenge keeping the Pied Pipers following from marching into a deadly cliff fall and today there are laws against being a Pied Piper of ill will.

Hence it doesnt really matter about the politics or personal moraliity of Trumps monoclonal antibody cocktail derived from fetal tissue research. It doesnt matter to him, and whatever spin Trump puts on it is how his top will twirl. How do normal people deal with this morality issue?

If a baby died during an abortion on demand, and the babys cells were used to save dozens of lives, there is still no equity in that. Thou shall not kill. But if the procedure (induced abortion) was not elective, dont waste a single cell if the parents are willing to donate tissue for scientific research just like an organ donor would do on their drivers license. That was the consensus of a half dozen doctors and nurses of The RINJ Foundation.

Read if you wish: Report of the Human Fetal Tissue Research Ethics Advisory Board FY2020.

The incipient cells in a laboratory growth Donald Trumps COVID-19 momoclonal antibody cocktail was derived from, were human embryonic kidney cells grown in a tissue culture from an aborted female fetus.

These cells have many names but the most precise name of the origin is HEK293.

HEK 293 come from aborted female fetus kidneys originally but can reliably reproduce and produce variations in a laboratory in a worthwhile quantity and many generations away from origin. Dozens of genetic sequences exist for research purposes.

The question of importance, is how many dead baby girl fetuses does it take to manufacture Regenerons REGN-COV2 monoclonal drugs, or any such drugs for COVID-19 in enough quantity to give an unknown percentage of 8 billion people the doses they would need. The answers to any of these questions are only wild guesswork until research has concluded with due approvals.

Remember that Remdesivir (Veklury), is an antiviral medication developed by Gilead Sciences, to be initially used as an Ebola remedy. Now Remdesivir has been cited in many good outcomes when used as a COVID-19 treatment. Anti-viral pharmacological research has a long way to go.

Stay out of the way of progress, is good advice.

If induced abortion is not seen for what it is, a medical procedure; and abortion as a form of birth control is not perceived as murder; the potential of HEK293 could be lost in foolish arguments by credulous people led by charlatans.

Stem cell research and fetal tissue research need to come out of the shadows.

Natural abortions happen; legitimate case-indicated induced abortions also happen.

Human kind is beyond tissue and organ donations, we need to get past this one. Either we select and train doctors so that they are trusted, or we agree that has been achieved and trust our medical practitioners to make the right calls. Making abortion laws is a fools game. It is a sometimes needed medical procedure, and a doctor/patient callsometimes only the doctor. Law or no law, it is that way. Doctors save the lives they can save.

In the meantime, Regenerons REGN-COV2 monoclonal drugs for COVID-19 are for the bigwigs, like Trumpvery expensive too.

Even after a SARS2 viable vaccine is approved and vaccinations begin, millions of people will still get sick from SARS-CoV-2 infection and too many will die. Hence a reliably effective treatment is needed. Hold nothing back if it has promise. This pathogen could with a little help from its hosts, wipe out much of the human race.

I suppose a cynical future historian might look at Trump rallies and suggest that COVID-19 killed all the credulous people, the stupid ones who ignored the warnings. They were told: socially distance themselves from others, stay home, wear a mask to go shopping, and keep clean. The evidence of quasi-suicidal behaviour at these superspreader events is in reams of video footage and still photographs. Dr. Sanjay Gupta of CNN did a study of many events and found that 82% had a surge in COVID-19 cases within a few weeks. The warnings were correct.

Some drugs are proving very useful from the common acetylsalicylic acid, to the also common famotidine heartburn medication. Clonidine seems to block cytokine storms in patients who already take this antihypertensive medication and some steroids have proven useful also for blocking the runaway immune systems in very sick patients. These are the direct experiences of the writer in running various medical clinics around the world. Still no one therapy is perfect for every patient. Compared to what we need to know, medical science knows relatively nothing about the SARS-CoV-2, but the learning process is ongoing and driven.

As the most vulnerable people in society are killed off by the virus, and as better treatments are derived learning from experience, SARS2 is killing a smaller percentage of the infected population. (Vulnerable persons must never be in circulation without an N95 mask. Absolutely never.)

Read back over this article. Think to yourself about the level of intelligence that it will take to solve some of these problems. Consider that COVID-19 may be a mere molecule on the tip of the spear that is coming at the human race.

The level of gray matter needed to solve these complex social, political and scientific issues is not possessed by the middle to lower echelons of the intelligence scale that men like Bolsonaro, Modi and Trump appeal to as populists. Better government is needed than these utter fools. Look for yourself. This pie chart is not just revealing, it is disgusting evidence of at least sociopathy and likely even greater ails at the top. Nearly two billion good people suffer the psychopathy of three you-know-whats.

The following graph shows daily excess deaths, likely directly or indirectly caused by COIVD-19. In any case they are deaths above normal and about 1.29x (in the current period) of the reported deaths from COVID-19. These are the real numbers of Americans who died in excess of the normal number of deaths from other causes.

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Aborted girl fetus kidneys made Trumps CoV meds. As SARS2 is unfettered in America, this needs thought - Feminine-Perspective Magazine (FPMag)

What to Know in Washington: Provisional Ballots May Play Role – Bloomberg Government

By Stem Cell Doctors

If the U.S. is still waiting to learn who the president will be days or even weeks after Tuesdays election, provisional ballots are likely to be at the center of any disputes.

They are the ballots cast by voters whose eligibility is questioned for some reason. Those ballots are set aside and held for a period of days after the election while workers determine whether they should be counted.

Experts say the number of provisional ballots this year may set a record, exceeding the 2.7 million cast in 2012 and almost 2.5 million cast in 2016, in part because some voters who requested ballots by mail are showing up at polls to vote in person. That could lead to late results in key battleground states such as Pennsylvania where President Donald Trump won by only 44,292 votes in 2016 if the race is close and the source of challenges and litigation.

Its just another one of those things that plays into the unusual nature of this election, G. Terry Madonna, director of the Center for Politics and Public Affairs at Franklin and Marshall College in Pennsylvania, said of provisional ballots.

Provisional ballots have come into play in the past. Democrat John Kerry held off conceding the 2004 presidential race to Republican George W. Bush until the morning after the election because he waited until it was clear the 157,714 provisional ballots cast in Ohio couldnt change the outcome.

In 2016, Trump carried Arizona by 91,234 votes, and there were 102,510 provisional ballots, according to the U.S. Election Assistance Commission. Pennsylvania had 26,451 provisionals, and that was before the commonwealth expanded voting by mail last year.

Greater use of mailed ballots, coupled with disruptions in mail service, may contribute to the bumper crop of provisional ballots. After initially urging voters to request mail-in ballots in response to the pandemic, Democratic leaders have been telling people to vote in person or deliver the ballot to an elections office or an approved drop box to avoid the risk of it being disqualified on technical grounds or having its delivery delayed by the U.S. Postal Service. Read more from Mark Niquette.

Photographer: David Paul Morris/Bloomberg

Voters who requested mail-in ballots but opt to vote in person could lead to more provisional ballots.

USPS Cites Covid, Holiday for Record Delays: The U.S. Postal Service delivered 80.85% of first-class mail on time for the week ending Oct. 23, compared with previous weeks figure of 85.58%, according to a news release. The agency listed factors including high mail volume, Covid-19 impacts, the Oct. 12 federal holiday and ongoing efforts to prioritize ballots for the Nov. 3 election. The on-time rate is the lowest of the year, according to the Save the Post Office website that tracks the agency. Read more from Todd Shields.

BGOVs Downballot Races to WatchReddit AMA: Join Bloomberg Governments elections guru Greg Giroux this afternoon on Reddit for an AMA on the congressional elections, where hell take questions on the races to watch. Follow his AMA here at 2 p.m. today.

Biden Win Would Offer Path to Kill Pipeline: Days after taking office, Trump cleared the way for construction of an oil pipeline in the Midwest that had been the focus of months of opposition by climate activists, celebrities and Native Americans. Now opponents of the Dakota Access Pipeline are pressuring Joe Biden to take the extraordinary step of returning the favor should he win the White House. Analysts said they couldnt recall a president shutting down an operating pipeline before, which is why its being viewed as a litmus test of how far hed go to appease environmentalists who have supported him. Read more from Ari Natter.

Biden Pledges Not to Extort South Korea: Biden pledged not to use the threat of cutting U.S. troop levels in South Korea as a bargaining chip, after the Trump administration demanded Seoul pay far more for American protection. Biden said if he wins the U.S. election next week, he wont be extorting Seoul with reckless threats to remove our troops, according to a special contribution he made to South Koreas Yonhap News Agency published today. Read more from Jon Herskovitz.

Trumps China Scorecard Shows Many Defeats: Trump ran for office pledging to rewrite the U.S.s economic ties with Beijing, which he blamed for hollowing out Americas manufacturing base and impoverishing its workers. But his four years in the White House have shown limited impact on the metrics he laid out. U.S. companies cite much the same concernsand the same growth objectiveswith regard to China today as they did when Trump took office. The unprecedented trade war that Trump launched, breaking GOP free-trade orthodoxy along the way, has ended up costing American factory jobs, not creating them, economists claim. The state support for Chinese enterprises that Trump pledged to confront remains intact.

Trumps term has, however, had a notable impact on American attitudes toward China. In time, that could prove the dynamic that affects economic ties in ways the current president has struggled to achieve. And it underscores that Washingtons policy on China is forever changed, regardless of who wins next Tuesdays election. Read more from Jenny Leonard.

Health-Care on the Ballot in Several States: Big money is betting on health-care initiatives in California, Oregon, and Colorado where voters are being asked Nov. 3 to add taxes on vaping, mandate that doctors always be on site when dialysis centers are open, and approve $5.5 billion in bonds for the sole stem cell research funding agency in the country. Tens of millions of dollars are fueling arguments over what to fund and why because, essentially, people are more interested in health-care initiatives, said Arturo Vargas Bustamante, associate professor in the Department of Health Policy and Management at the University of California, Los Angeles. Read more from Joyce E. Cutler.

Gerrymander Power on the Line: A shift toward independent redistricting commissions helped spur national political parties to spend record cash in the hope of controlling the next congressional redistricting. The outcomes in just a few races in a few states will determine the Republican Partys chances of winning congressional majorities for the next decade. And were fighting like hell to win, Republican State Leadership Committee President Austin Chambers said in an email. His group raised $23 million in the third quarter and is targeting 115 districts that could hold the keys to a 136-seat swing in the U.S. House.

Democrats are fighting money with money. The Democratic Legislative Campaign Committee has pledged to spend $50 million in state races this cyclemore than six times what it spent in 2010. Read more from Alex Ebert.

Biden Courts Latino Voters as Tie-Breakers: Biden appealed to Hispanic voters in Florida, a closely divided battleground state where a win next week would give him the presidency. The heart and soul of the country is at stake right here in Florida. Its up to you. You hold the key. If Florida goes blue, its over, Biden said in a neighborhood in Broward County, which stretches south from Fort Lauderdale toward Miami and is a key source of Democratic votes in the state. Read more from Jennifer Epstein.

Facebook Says Technical Hiccups Improperly Blocked Campaign Ads: Facebook revealed yesterday how internal technical glitches disrupted the delivery of some ads from the Biden and Trump campaigns, but said it made changes to resolve those hiccups in the run-up to the November election. The social media giants admission followed complaints from the Biden camp about how thousands of its ads were blocked. Facebook said in a blog post it spotted unanticipated issues affecting both campaigns, including technical flaws that caused a number of ads to be paused improperly. Read more from Sarah Frier.

Trumps Social Media Order Defeats Legal Challenge: The Trump administration defeated a challenge by Rock the Vote and Voto Latino to a recent executive order targeting social media companies that fact-check the presidents posts about the election, when a federal judge said yesterday that the get-out-the-vote groups lacked standing to bring the case. Judge William H. Orrick said the groups couldnt show the order regulated Facebook, Twitter, or another social media website in any way or credibly threatened them with prosecution. Read more from Mike Leonard.

BGOV OnPoint: Section 230 Internet Shield Faces Bipartisan Attacks.

Zeta Disrupts Early Voting in Georgia: Hurricane Zeta caused disruptions to early voting across the South yesterday, including in the key battleground states of Georgia and North Carolina. Zeta, now a tropical storm, knocked out power to more than 1 million homes and businesses as early in-person voting enters a final stretch with five days to go until Election Day. Friday is Georgias last day to vote while voters in North Carolina have until Saturday. Read more from Misyrlena Egkolfopoulou and Joe Ryan.

More Hawaiians Voted Early Than All of 2016: Early voting in Hawaii has already surpassed the total number of ballots cast in the state in the 2016 election. Data from the U.S. Elections Project, which tracks early voting, found Hawaii has seen turnout hit 104.5% of its total from the last election. More than half of all registered voters in Hawaii have already sent in their ballots, topping the record for the total number of votes cast in the state for a general election. Read more from Emma Kinery.

U.S. Sets Daily Virus Case Record: New U.S. cases topped 86,000, setting a new daily record, as the outbreak intensifies ahead of next weeks presidential election. Read more from Bloomberg News.

U.S. Buying Gowns from Untested Makers: Several U.S. companies that won almost half a billion dollars in government contracts to make hospital gowns appear to have too few workers and not enough factory space to complete the job when the awards were made, according to a Bloomberg Law analysis. At least 11 contractors and subcontractors began making protective gear only after the pandemic began, according to press releases and news reports. Of the 15 primary contractors, eight had never received a federal contract prior to 2020, according to federal government contracting records. The Defense Department says contractors went through a rigorous process and met stringent criteria.

Still, members of Congress are raising questions. Some of those contracts have been to companies that have very little experience with producing that kind of equipment, that the standards have not always been up to par, and its created some real challenges, Sen. Jeanne Shaheen (D-N.H.) said during a Senate Armed Services committee hearing Oct 1. Read more from Shira Stein.

Covid Relief Laws May Bolster ACA Legal Case: Republicans may have hurt their own legal case against Obamacare by repeatedly expanding on and amending the signature health law since 2017, most recently in their response to the coronavirus pandemic. You cant build on the ACAs protections for the Covid bills if the act doesnt exist, said Abbe Gluck, a professor of law and the founding faculty director of the Solomon Center for Health Law and Policy at Yale Law School.

The U.S. Supreme Court will assess legal arguments on the constitutionality of the Affordable Care Act on Nov. 10. What Congress intended to do with the ACA is a central line of dispute in the high stakes case, and the pandemic has given supporters of the law a new opportunity to prove it was meant to stay. Read more from Lydia Wheeler.

New Projection Shows Higher Death Toll: The Institute for Health Metrics and Evaluation, an influential modeling group, is projecting a higher death toll in the U.S. amid the surge in Covid cases and hospitalizations. The group is now projecting about 405,000 deaths due to the virus by Feb. 1, representing a nearly 20,000 increase from a prior projection of 386,000. Europe is seeing a surge right now and Europe is ahead about a month from the United States, said Ali Mokdad, a professor of health metrics sciences with IHME. So basically we are watching what would unfold here in the United States. Read more.

CDC Evictions Moratorium Upheld by Judge: A federal judge ruled against landlord groups trying to block the U.S. Centers for Disease Control and Preventions national moratorium on evictions amid the coronavirus crisis. U.S. District Judge J.P. Boulee in Atlanta yesterday rejected a motion for a preliminary injunction brought by the New Civil Liberties Alliance and National Apartment Association, which represents some 85,000 landlords responsible for 10 million rental units. The judge said the public interest in curtailing the spread of Covid outweighed the landlords economic interest. Read more from Chris Dolmetsch.

Trump Rule Leads Contractors to Cut Training: Trumps recent attempt to curb corporate diversity training will linger even if he loses Tuesdays election to Biden. Already, federal contractors are unsure of what they can say about race. More than 300 events, training programs, research projects and other diversity-related activities have been delayed or canceled because of concern about a Sept. 22 executive order aimed at banning federal contractors and agencies from using terms in diversity training that the administration considers divisive and illegal, according to the African American Policy Forum, a social justice think tank. A Labor Department official said last week that the agencys already received more than 100 complaints via a government hotline to report possible violations. Read more from Paige Smith and Jeff Green.

Hackers Plan More Attacks on U.S. Hospitals: A Russia-based ransomware group responsible for a new wave of attacks against U.S. hospitals is laying the groundwork to cripple at least ten more, according to the cybersecurity firm Prevailion. Prevailions analysis comes a day after the FBI and two other federal agencies issued a warning about an imminent and credible threat to hospitals and health-care providers from cyberattacks, including ransomware capable of locking entire computer networks. The hacking group responsible has already hit at least nine hospitals in three weeks, crippling critical computer systems and demanding multimillion-dollar ransoms. Read more from Alyza Sebenius, William Turton and Michael Riley.

Insurers Must Post Out-of-Pocket Medical Costs: Health insurers will have to post on the internet personalized out-of-pocket costs to patients under a new rule finalized yesterday. Insurance plans will also be required to make their in-network negotiated rates with doctors and allowable out-of-network rates available to the public, according to the multiagency rule. They will be required to post their negotiated pharmaceutical prices and the historical net prices for all their covered drugs. Read more from Shira Stein, Lydia Wheeler and John Tozzi.

How the Google Case Could Play Out: Google and the Justice Department are set to face each other in court today for the first time since the government sued the company for illegally monopolizing internet search. The hearing marks the first time attorneys for Google and the government will come together to start mapping out the the litigation process. It will set the stage for whats shaping up to be a drawn-out court battle that could ultimately weaken Googles gatekeeper position over the web if the government is successful. Vicky Graham lays out how to follow the case as it winds its way through federal court.

737 Jet Crash Victims Demand U.S. Records: The relatives of the 157 people who died in the crash of a Boeing 737 Max in Ethiopia are demanding more records from U.S. safety agencies, according to a pair of letters sent on the second anniversary of another accident involving the plane. A letter to the National Transportation Safety Board, which assisted in the investigation of both crashes, accused it of an unreasonable pro-secrecy stance. Alan Levin has more.

Gray Wolf Protections Stripped, Stirring Lawsuit Threats: The Interior Department announced yesterday it will strip endangered species protections from the gray wolf. Environmental groups vowed to challenge the decision in court, saying it violates the Endangered Species Act by ignoring the best available science. If Democrat Joe Biden wins the presidency, his administration could seek to overturn the move. Todays action reflects the Trump administrations continued commitment to species conservation based on the parameters of the law and the best scientific and commercial data available, said Interior Secretary David Bernhardt. Stephen Lee and Kellie Lunney have more.

Administration Appeals Court Order on Visa Ban: The Trump administration is appealing a California federal courts Oct. 1 ruling that blocked the departments of State and Homeland Security from barring entry to the U.S. for certain temporary work visa holders. In their filing, U.S. Justice Department lawyers signaled theyll ask the San Francisco-based U.S. Court of Appeals for the Ninth Circuit to reinstate Trumps proclamation in full, Genevieve Douglas reports.

To contact the reporters on this story: Zachary Sherwood in Washington at zsherwood@bgov.com; Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Loren Duggan at lduggan@bgov.com; Michaela Ross at mross@bgov.com

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What to Know in Washington: Provisional Ballots May Play Role - Bloomberg Government

Wrist Pain: Causes and Available Treatment Options – Lifesly.com

By Platelet Rich Plasma Injections

Hands are an essential part of the body as they perform numerous tasks daily. You may assume that your hands will always be fine. While going about your daily activities, you may experience wrist pain, which can be traumatizing. Wrist pain can deter you from performing your daily tasks. Your Jersey City hand and wrist pain specialists at Garden State Pain Control offer specialized treatment procedures for hand and wrist pain.

You can experience pain in the hand and wrist due to:

Inappropriate use

Overworking

Severe injury

System-wide disorders

You may sprain or fracture your hands if you misuse them or carry massive weights that your hands cannot handle. You may also accidentally hurt your hands during sporting activities or an accidental slip to the ground. When you hurt your hands, you are likely to experience a strain due to stretching or tearing of tendons. On the other hand, sprains come about when ligaments receive aggressive stretches or bends to the extent of causing pain. Fractures occur when the pressure acting on your bones is irresistible, resulting in breaks and excruciating pain. Systemic disorders like osteoarthritis and rheumatoid arthritis can also lead to pain in the wrist. Further, prolonged use of the hands leads to wrist and hand pains.

Carpal tunnel syndrome arises due to a nerve compression resulting in a tingling sensation and is usually experienced when you use your hand often. Signs of carpal tunnel syndrome include a tingling sensation, loss of sensation, or pain in your fingers, usually the thumb, index, and middle fingers. You are likely to feel uneasiness in your wrist or the whole arm. Additional symptoms are:

Persistent pain after doing a task

Inability to firmly hold on to tiny items

Severe hand and wrist pain at night

The professional team at Garden State Pain Control uses ultrasound to examine your ligaments, structural bones, joints, and other parts. This procedure involves using a handheld probe that disperses sound waves in high frequency, bouncing off your bones, ligaments, and tendons. The computer collects these sound waves and employs them to produce a clear image of the pain points.

The doctors at Garden State Pain Control have specialized in pain medicine, making them able to examine your wrist problems and administer the correct treatment. Holding on to chronic hand and wrist pain can lead to long-term damage. The treatment procedure for persistent hand and wrist pain include:

Taking pain relievers

Alternating hands when handling a task

Relaxing your hand

Your physicians also provide platelet-rich plasma injections that help in soothing the pain. Injecting PRP promotes the production of soft tissue and bones, which enhances faster healing.

It is essential to take care of your hands as they handle many tasks daily. It would help if you did not ignore hand and wrist pain. Reach out to your Garden State Pain Control doctor to learn how to keep your hands free from pain.

The post Wrist Pain: Causes and Available Treatment Options appeared first on Living Gossip.

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Wrist Pain: Causes and Available Treatment Options - Lifesly.com

Panelists debate the implications and ethics of stem cell research – Johns Hopkins News-Letter

By Embryonic Stem Cells

Panelists agreed that as advancements in genetic techniques evolve, researchers should be cognizant of social and health inequities.

The Alexander Grass Humanities Institute (AGHI), in conjunction with Great Talk, Inc., hosted a panel of scientists to speak about the ethical considerations and implications of stem cell research on Oct. 21.

The event was moderated by Director of AGHI William Egginton. The four panelists included two experts in genomics research, a journalist who specializes in the role of technology in biomedical research and an expert in medical law.

Dr. Anthony Wynshaw-Boris, chair of the Department of Genetics and Genome Sciences at Case Western Reserve University School of Medicine, discussed how cell lines were cultivated as tools in the past for scientists to use to grow cell cultures to study diseases or develop vaccines. However, there wasnt as much debate about the development of these tools in the past as there is now.

These are scientific tools that we use. The political and social aspects... are arising today because of our polarization, Wynshaw-Boris said.

The panel had an in-depth conversation regarding the ethics of the use of scientific tools such as stem cell lines derived from fetal tissue, embryonic cells, abortion-derived cell lines and cells acquired without consent.

Dr. Eric Green, director of the National Human Genome Research Institute at the National Institutes of Health, argued that the investment that has been made in these cell lines to calibrate them for use in biomedical research cannot be ignored.

Should there be a halt on the use of that mature tool because of its origins that were created in a time when there was a different view? Green asked.

Antonio Regalado, senior editor for biomedicine at MIT Technology Review who writes about the impact of technology on medicine and biomedical research, responded to Greens query.

Regalado brought up the fact that makeup companies have been facing a lot of backlash recently for testing their products on animals. Regalado pointed out that makeup companies could then use a similar argument by saying that since they have already invested money in animal testing procedures, they should not have to find new, less harmful methods of testing.

I don't know that we should rule out the possibility of alternatives if the scientific community decides to put their minds to it. Perhaps an equivalent cell line could be developed, Regalado said.

Diane Hoffman, director of the Law and Health Care Program at the University of Maryland Francis King Carey School of Law, described various perspectives in debate over the ethical concerns of stem cell research.

The challenge, according to Hoffman, is striking a balance between implementing a blanket policy through the government and informing consumers to allow them to make ethical decisions.

Industry wanting innovation, and government wanting safety and efficacy, and consumers wanting access. Those three things are... how we consider these ethical issues, Hoffmann said.

The conversation then shifted to eugenics, the practice of editing human DNA to achieve specific, desirable characteristics, such as eliminating diseases, changing eye color or editing IQ.

Green described an initiative funded by the Human Genome Project, the Ethical, Legal and Social Implications Research Program (ELSI), which focuses on the ethical, legal and social implications of biomedical research.

We can meld together what is scientifically possible to what is the body of evidence of what has come out when we have looked at these ELSI issues and then have conversations... and try to come to consensus on what the guardrails should look like, Green said.

Hoffmann echoed Green, describing the need of the scientific community to also consider allocation of these resources.

Weve got a ways to go in terms of thinking about... how we can be more just in our allocation of medical resources and the benefits of the research were doing, Hoffmann said.

She brought up the idea of giving priority in receiving benefits to vulnerable populations that have been previously harmed by the health-care system.

Wynshaw-Boris added that each study that is conducted needs to address the ELSI considerations mentioned by Green.

Studies have to be done... in partnership with diverse populations, and we have to be committed to that, Wynshaw-Boris said. We have to make progress on it all the time, and that's what we have to be committed to.

The discussion concluded with a consensus among the panelists that the scientific community needs to address social and health inequities as advancements in genetics and genomic techniques continue to occur.

We have to bring more trust to science than exists now, Green said.

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Panelists debate the implications and ethics of stem cell research - Johns Hopkins News-Letter

Stem Cell and Regenerative Therapy Market to Remain Balanced During the the COVID-19 Period – re:Jerusalem

By Embryonic Stem Cells

The global stem cell and regenerative medicines market should grow from $21.8 billion in 2019 to reach $55.0 billion by 2024 at a compound annual growth rate (CAGR) of 20.4% for the period of 2019-2024.

Report Scope:

The scope of this report is broad and covers various type of product available in the stem cell and regenerative medicines market and potential application sectors across various industries. The current report offers a detailed analysis of the stem cell and regenerative medicines market.

The report highlights the current and future market potential of stem cell and regenerative medicines and provides a detailed analysis of the competitive environment, recent development, merger and acquisition, drivers, restraints, and technology background in the market. The report also covers market projections through 2024.

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The report details market shares of stem cell and regenerative medicines based on products, application, and geography. Based on product the market is segmented into therapeutic products, cell banking, tools and reagents. The therapeutics products segments include cell therapy, tissue engineering and gene therapy. By application, the market is segmented into oncology, cardiovascular disorders, dermatology, orthopedic applications, central nervous system disorders, diabetes, others

The market is segmented by geography into the following regions: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The report presents detailed analyses of major countries such as the U.S., Canada, Mexico, Germany, the U.K. France, Japan, China and India. For market estimates, data is provided for 2018 as the base year, with forecasts for 2019 through 2024. Estimated values are based on product manufacturers total revenues. Projected and forecasted revenue values are in constant U.S. dollars, unadjusted for inflation.

Report Includes:

28 data tables An overview of global markets for stem cell and regenerative medicines Analyses of global market trends, with data from 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Details of historic background and description of embryonic and adult stem cells Information on stem cell banking and stem cell research A look at the growing research & development activities in regenerative medicine Coverage of ethical issues in stem cell research & regulatory constraints on biopharmaceuticals Comprehensive company profiles of key players in the market, including Aldagen Inc., Caladrius Biosciences Inc., Daiichi Sankyo Co. Ltd., Gamida Cell Ltd. and Novartis AG

Summary

The global market for stem cell and regenerative medicines was valued at REDACTED billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of REDACTED to reach approximately REDACTED billion by 2024. Growth of the global market is attributed to the factors such as growingprevalence of cancer, technological advancement in product, growing adoption of novel therapeuticssuch as cell therapy, gene therapy in treatment of chronic diseases and increasing investment fromprivate players in cell-based therapies.

In the global market, North America held the highest market share in 2018. The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period. The growing government funding for regenerative medicines in research institutes along with the growing number of clinical trials based on cell-based therapy and investment in R&D activities is expected to supplement the growth of the stem cell and regenerative market in Asia-Pacific region during the forecast period.

Reasons for Doing This Study

Global stem cell and regenerative medicines market comprises of various products for novel therapeutics that are adopted across various applications. New advancement and product launches have influenced the stem cell and regenerative medicines market and it is expected to grow in the near future. The biopharmaceutical companies are investing significantly in cell-based therapeutics. The government organizations are funding research and development activities related to stem cell research. These factors are impacting the stem cell and regenerative medicines market positively and augmenting the demand of stem cell and regenerative therapy among different application segments. The market is impacted through adoption of stem cell therapy. The key players in the market are investing in development of innovative products. The stem cell therapy market is likely to grow during the forecast period owing to growing investment from private companies, increasing in regulatory approval of stem cell-based therapeutics for treatment of chronic diseases and growth in commercial applications of regenerative medicine.

Products based on stem cells do not yet form an established market, but unlike some other potential applications of bioscience, stem cell technology has already produced many significant products in important therapeutic areas. The potential scope of the stem cell market is now becoming clear, and it is appropriate to review the technology, see its current practical applications, evaluate the participating companies and look to its future.

The report provides the reader with a background on stem cell and regenerative therapy, analyzes the current factors influencing the market, provides decision-makers the tools that inform decisions about expansion and penetration in this market.

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Stem Cell and Regenerative Therapy Market to Remain Balanced During the the COVID-19 Period - re:Jerusalem

Study Identifies Pitfall for Correcting Mutations in Human Embryos with CRISPR – Columbia University Irving Medical Center

By Embryonic Stem Cells

In a paper published today in the journal Cell, scientists describe unexpected, undesirable outcomes after editing genes in human embryos with CRISPR, a genomic editing system.

The study, the most detailed analysis to date of CRISPR in human embryos, shows that applying gene editing technologyto repair a blindness-causing gene early in the development of a human embryo often eliminates an entire chromosome or a large section of it.

"Our study shows that CRISPR/Cas9 is not yet ready for clinical use to correct mutations at this stage of human development, says the studys senior author Dieter Egli, assistant professor of developmental cell biology in the Department of Pediatrics at Columbia University Vagelos College of Physicians and Surgeons.

The genome editing system called CRISPR/Cas9 has revolutionized molecular biology in recent years, and its discoverers were honored with this year's Nobel Prize in chemistry. The system allows scientists to make precise changes in the genomes of cultured cells, living tissues, and animal embryos.

The first use of CRISPR in human embryos was reported in 2015. Then in 2018, He Jiankui claimed to have performed the procedure in a pair of twin embryos, eliciting a firestorm of condemnation from scientists and government officials worldwide.

In the new paper, Egli and his colleagues tested CRISPR/Cas9 genome editing's effects on early-stage human embryos carrying a mutation in a gene called EYS (eyes shut homolog), which causes hereditary blindness.

We know from previous studies in differentiated human cells and in mice that a break in the DNA results in mostly two outcomes: precise repair or small local changes. At the EYS gene, these changes can yield a functional gene, though it is not a perfect repair, says Michael Zuccaro, a research scientist at Columbia University Vagelos College of Physicians and Surgeons and co-lead author of the paper.

When Zuccaro, Egli, and their colleagues looked at the entire genomes of the modified embryos in this study, they identified another outcome. We learned that in human embryonic cells, a single break in the DNA can result in a third outcomethe loss of an entire chromosome or sometimes a large segment of that chromosome, and this loss of the chromosome is very frequent, says Zuccaro.

In 2017, a study reported the successful correction of a heart disease-causing mutation in normal human embryos using CRISPR. Comprehensive data from the new study offer a different interpretation of these results: Instead of being corrected, the chromosome carrying the mutation may have been lost altogether.

"If our results had been known two years ago, I doubt that anyone would have gone ahead with an attempt to use CRISPR to edit a gene in a human embryo in the clinic," Egli says.Our hope is that these cautionary findings should discourage premature clinical application of this important technologybut can also guide responsible research to achieve its ultimate safe and effective use.

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Study Identifies Pitfall for Correcting Mutations in Human Embryos with CRISPR - Columbia University Irving Medical Center

Yale New Haven Health Docs: Interpreting the Uptick in Covid-19 Cases – Greenwich Free Press

By Embryonic Stem Cells

At a press conference this week, doctors from Yale New Haven Health System gave a snapshot of the Covid-19 uptick in Connecticut.

On Tuesday the System had 90 inpatients, more than 3-1/2 times the number at the end of September.

In the past two weeks the System had seen a 50% increase from 64 on Oct 13th to 92 cases on Monday.

A month ago there were only two Covid patients in the Systems ICUs. On Tuesday there were 22 with eight on ventilators. That was after many days with no ventilated Covid-positive patients.

While the numbers represent an uptick, they are still well below the peak of 800 cases last spring.

But it doesnt feel very good, said CEO Marna Borgstron. People are tired. Tired of the pandemic. Tired of social distancing. Tired of wearing masks.

As of Tuesday, the 90 Covid-19 cases across the System were as follows:

51 at Yale New Haven Hospital 16 at Bridgeport Hospital 11 at Lawrence and Memorial Hospital in New London 5 at Greenwich Hospital 6 at Westerly Hospital.

Dr. Tom Balcezak, Chief Medical Officer for the System, and Yale New Haven Hospital Infectious Disease Specialist Dr. Onyema Ogbuagu, who is working on the Pfizer trial for a vaccination and is deeply involved in care for Covid-19 patients, talked about the recent uptick.

We didnt know that (mask wearing) worked in the first part of this pandemic, Balcezak said. There is now scientific certainty that mask wearing and social distancing does work.

How Bad Will It Get?

Balcezak said it was impossible to forecast numbers or predict when a peak might come.

He said a wastewater sampling model showed the Greenwich area was seeing some slow growth, and the hot spot area to watch was eastern Connecticut.

As for Thanksgiving and Halloween, Balcezak said, We all have families and desire to reconnect with out families and friends, but this is not the time to be doing that.

Implications for Flu Season

Balcezak said with the arrival of fall, there was the potential for a flu pandemic in addition to Covid-19. He urged residents to get flu shots to avoid a twindemic of flu and Covid-19.

Dr. Ogbuagu said there was concern about how the flu would mimic Covid-19.

Balcezak agreed, adding the challenge wold be to sort out flu patients from Covid patients, who need different therapies and cohorting.

Balcezak said the southern hemisphere foreshadows what might be in store for Connecticut.

It appears the southern hemisphere had a very light flu season this year, he said. But we need to do everything we can to lock that in. That means getting your flu shot this year. We dont need our emergency departments and doctors offices clogged with folks that have respiratory illness.

Vaccine Trial at Yale New Haven Hospital with Pfizer

Dr. Ogbuagu said there are 300 people in the trial in New Haven. The target number is 44,000, which they are approaching, as the trial is multinational.

Enrollment is going well. Up to 70% of participants have already received the second of two vaccines. (The second vaccine comes three weeks after the first.)

I think the earliest a vaccine would receive approval would be end of December or January 2021, at best, Dr. Ogbuagu said.

Its been incredible to watch the speed with which our science has moved with this pandemic, Balcezak said. Were already talking about novel therapeutics and hopefully will have a vaccine approved in the next couple of months.

Balcezak added that when the first vaccine becomes available, it might not be the best vaccine, and wont prevent the virus.

He explained when the Covid-19 virus enters the body through the respiratory system, the immunity will stop it replicating, but the vaccine will not prevent infection. It will prevent symptoms but vaccinated people could still be contagious.

We may have to wait for a vaccine that prevents infection, he said. Even if you have got the vaccine, you will still be infectious. Therefore, mask wearing will still be the standard.

Dr. Ogbuagu said the Pfizer trial has already gone through phases 1 and 2, and the phase 3 trials are advanced. The trials are randomized. Half the people receive the vaccine and the others receive a placebo.

Dr. Ogbuagu said the study has a diverse enrollment, and not only enrolls adults and elderly individuals, but also enrolls pediatric age participants from age 12 +, and immune-compromised patients including HIV patients. Over half the people enrolled in the trial identify as racial minorities.

Asked about the use of embryonic stem cells in some vaccine trials, Dr. Ogbuagu said that scenario was not unique to Covid vaccines.

There were vaccines long before Covid, like Rubella, which is German measles, and shingles vaccines, which have utilized human embryonic cells to advance development, he said.

Dr. Balcezak said it was important to note that these are tissues have been grown over many years.

They are involved in early development, he said. But for large scale mass production of these vaccines, theyre going to use traditional manufacturing methodologies that dont involve stem cells.

Why are Covid-19 Illnesses Less Severe than in the Spring?

Dr. Balcezak said much had been learned about treating Covid-19 patients.

Were more liberal with the use of steroids than we were early on, he said. And we have figured out what medications do not work.

Theres been a lot of negative studies whether it be Hydroxychloroquine, or Azithromycin weve stopped the utilization of those drugs, Balcezak said.

We continue to use Rendesivir, which seems to have a small benefit, at least in terms of length of hospitalization.

He said theyd also learned more about non therapeutic therapies.

Its putting patients on their bellies, or proning them. Its how you manage the ventilator and how you use oxygen and high flow oxygen, he said. Weve seen mortality rates fall substantially.

Balcezak cautioned, Doing better was far from perfect, and while the System is seeing a small number of deaths compared to the spring, theyd like to see the number fall to zero.

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Yale New Haven Health Docs: Interpreting the Uptick in Covid-19 Cases - Greenwich Free Press

Outlook for stem cell therapy – its role in tendon regeneration – different treatments for horse tendon injuries – Trainer Magazine

By Embryonic Stem Cells

After a tendon injury occurs, horses need time off work with a period of box rest. Controlled exercise is then introduced, which is built up slowly to allow a very gradual return to work. This controlled exercise is an important element of the rehabilitation process, as evidence suggests that exposing the tendon to small amounts of strain has positive effects on the remodelling phase of tendon healing. However, depending on the severity of the initial injury, it can take up to a year before a horse can return to racing. Furthermore, when tendon injuries heal, they repair by forming scar tissue instead of regenerating the normal tendon tissue. Scar tissue does not have the same strength and elasticity as the original tendon tissue, and this makes the tendon susceptible to re-injury when the horse returns to work. The rate of re-injury depends on the extent of the initial injury and the competition level that the horse returns to, but re-injury rates of up to 67% have been reported in racing thoroughbreds. The long periods of rest and the high chance of re-injury therefore combine to make tendon injuries the most common veterinary reason for retirement in racehorses. New treatments for tendon injuries aim to reduce scar tissue formation and increase healthy tissue regeneration, thereby lowering the risk of horses having a re-injury and improving their chance of successfully returning to racing.

Over the past 15 years, the use of stem cells to improve tendon regeneration has been investigated. Stem cells are cells which have the remarkable ability to replicate themselves and turn into other cell types. Stem cells exist from the early stages of development all the way through to adulthood. In some tissues (e.g., skin), where cells are lost during regular turnover, stem cells have crucial roles in normal tissue maintenance. However, in most adult tissues, including the tendon, adult stem cells and the tendon cells themselves are not able to fully regenerate the tissue in response to an injury. In contrast, experimental studies have shown that injuries to fetal tissues including the tendon, are capable of undergoing total regeneration in the absence of any scarring. At the Animal Health Trust in Newmarket, we have an ongoing research project to identify the differences between adult and fetal tendon cells and this is beginning to shed light on why adult cells lead to tendon repair through scarring, but fetal cells can produce tendon regeneration. Understanding the processes involved in fetal tendon regeneration and adult tendon repair might enable new cell based and/or therapeutic treatments to be developed to improve tendon regeneration in adult horses.

In many tissues, including fat and bone marrow, there is a population of stem cells known as mesenchymal stem cells (MSCs). These cells can turn into cells such as bone, cartilage and tendon in the laboratory, suggesting that they might improve tendon tissue regeneration after an injury. MSC-based therapies are now widely available for the treatment of horse tendon injuries. However, research has demonstrated that after injection into the injured tendon, MSCs do not turn into tendon cells. Instead, MSCs produce factors to reduce inflammation and encourage better repair by the tissues own cells. So rather than being the builders of new tendon tissue, MSCs act as the foreman to direct tissue repair by other cell types. Although there is some positive data to support the clinical application of MSCs to treat tendon injuries in horses, placebo controlled clinical trial data is lacking. Currently, every horse is treated with its own MSCs. This involves taking a tissue biopsy (most often bone marrow or adipose tissue), growing the cells for 2-4 weeks in the laboratory and then injecting them into the site of injury. This means the horse must undergo an extra clinical procedure. There is inherent variation in the product, and the cells cannot be injected immediately after an injury when they may be the most beneficial.

To allow the prompt treatment of a tendon injury and to improve the ability to standardise the product, allogeneic cells must be used. This means isolating the cells from donor horses and using them to treat unrelated horses. Experimental and clinical studies in horses, mice and humans suggest that this is safe to do with MSCs, and recently an allogeneic MSC product was approved for use in the EU for the treatment of joint inflammation in horses. These cells are isolated from the circulating blood of disease-screened donor horses and are partially turned into cartilage cells in the laboratory. They are then available off the shelf to treat unrelated animals. Allogeneic MSC products for tendon injuries are not yet available, but this would provide a significant step forward as it would allow horses to be treated immediately following an injury. However, MSCs exhibit poor survival and retention in the injured tendon and improvements to their persistence in the injury site, and with a better understanding of how they aid tissue regeneration, they are required to enable better optimised therapies in the future.

Our research has previously derived stem cells from very early horse embryos (termed embryonic stem cells, ESCs. Figure 2). ESCs can grow in the laboratory indefinitely and turn into any cell type of the body. These properties make them exciting candidates to provide unlimited numbers of cells to treat a wide range of tissue injuries and diseases. Our experimental work in horses has shown that, in contrast to MSCs, ESCs demonstrate high survival rates in the injured tendon and successfully turn into tendon cells. This suggests that ESCs can directly contribute to tissue regeneration.

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Outlook for stem cell therapy - its role in tendon regeneration - different treatments for horse tendon injuries - Trainer Magazine

Is the Pro-Life Movement on a Collision Course with the Coronavirus? – The Dispatch

By Embryonic Stem Cells

Amid the news explosion that followed President Trumps COVID-19 diagnosis and brief convalescence earlier this month, there was a nugget you might have missed: The antibody treatment from biotech company Regeneron the president tookseemingly to great effecthad been developed in part by means of cells derived from fetal tissue.

Most of the discussion around this revelation concerned whether it showed the president to be a hypocriteeither personally because of his stated pro-life beliefs, or as a matter of policy because his administration has suspended federal funding for scientific research involving fetal tissue. (Both claims were dubious: There was no reason to believe the president knew the provenance of the Regeneron cocktail when he was treated with it, and the kind of fetal-derived cells used to develop the drug were not included in the administrations funding freeze.)

But the news portended a larger problem that may prove important in months to come: the ethical objections other pro-life people may have to new COVID treatmentsincluding vaccineswith similar issues in their development history.

I think its going to test our convictions about these things, said Dr. C. Ben Mitchell, a professor of moral philosophy at evangelical Union University and senior fellow at the Center for Bioethics & Human Dignity. Whether or not we are going to be consistent with our convictions.

Beyond the central aim of ending legal abortion, no issue has so united the pro-life movement over the last few decades as the push to prevent fetal and embryonic remains from being used in medical research. In the 2000s, the battle involved embryonic stem cell research: President Bush prohibited federal funding for research involving new embryonic stem cell lines in 2001, a policy President Obama reversed in 2009. More recently, the issue has been researchers use of fresh tissue from recent abortions, following activist David Daleidens 2015 expos on Planned Parenthoods practice of selling organs from aborted fetuses to medical research companies.

But while pushing for public policy changes and supply chain reforms to make researchers less reliant on ongoing abortions, pro-lifers have also struggled with a parallel issue on a more personal level: whether its permissible to make use of treatments developed via the use of fetal tissue that already exist. If abortion is evil, they ask themselves, then can I in good conscience allow myself to benefit from medicines that rely on the practice?

Such questions are complicated by the fact that, unlike the tissue research that has dominated pro-life policy space in recent years, many medical products in current use, including a number of childhood vaccines, have a connection to abortion that is distant and tenuous. The cell cultures used in developing such medicines are most accurately described not as fetal cells themselves, but as cells that are fetal-derived: Cells originally taken from an aborted fetus that have been cultivated to multiply freely ever since.

The most widely used of these cell lines date back to just a handful of abortions in Europe in the 1960s. The WI-38 cell line, which has been used to develop vaccines for rubella, rabies, measles, mumps, and various other diseases, is derived from the lung tissue of a fetus aborted in Sweden in 1962; The MRC-5 line, used to produce vaccines for Hepatitis A and polio, dates back to 1966. Other lines are used for other purposes: HEK293 cells, which are derived from fetal kidney cells isolated in the Netherlands in the early 1970s, can be used to create virus-like cells that arent able to infect humans. Researchers use these pseudoviruses to test new therapeutics without having to handle live virus themselves, reducing the need for extreme biosafety precautions in laboratory settings. (The aforementioned Regeneron made use of HEK293 cells in this way.)

These cell cultures wont reproduce infinitely, but saying so almost feels like a technicality: Descendants of the WI-38 and MRC-5 lines have been used to create hundreds of millions of doses of vaccines over the past half-century.

Going by any sort of costbenefit analysis, the use of these cell lines has been a force for good in the world. By making use of the remains of a bare handful of elective abortionsabortions that would have taken place whether or not researchers decided to use thema staggering number of people around the world have been spared the miseries of a whole host of wretched and deadly diseases.

But for those who advocate for decoupling from such practices, simply to use the language of cost and benefit in the first place is to give away the game. If thats the measure, they argue, its hard to see how you could oppose any promising medical research, even the most depraved: How can you weigh the suffering of a few unfortunates against the ongoing benefits to all humanity of curing a deadly disease?

These sorts of ethical questions arent the exclusive domain of the pro-life movement. What posture we ought to take toward ill-gotten medical research is a question that has long occupied bioethicists, given how much of the science underpinning our current understanding and practice of medicine was conducted in unethical waysoften even by the standards of their own time, and even more so by the more exacting standards of the present.

The classic example, of course, is the gruesome human experimentation carried out by Nazi doctors in concentration camps, but there are examples closer to home, too: black men in Alabama whose untreated syphilis was allowed to fester for decades so government researchers could observe the progress of the disease, all the while assuring the subjects they were being treated; developmentally disabled children in New York given chocolate milk laced with feces to deliberately infect them with hepatitis as part of an effort to develop a vaccine.

Other ethical issues involve the origin of immortalized cell cultures in particular. The longevity of these cell lines is such that many of them predate modern medical standards on ethical human research, which werent truly codified until the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research, established by Congress for the purpose in 1974, published its Belmont Report in 1979. The oldest such cell line in existence is a culture of cervical cancer cells taken from a woman named Henrietta Lacks in 1951, who died of the disease that same year. Lacks never consented to having her cells cultured; nor did the women who obtained the abortions that resulted in the WI-38 or MRC-5 cells.

These fraught ethical issues are not a thing of the past. After decades of lobbying, the Lacks family finally won a partial concession from the National Institutes of Health in 2013 to place some restrictions on medical access to information about their relatives cells. Pro-life organizations continually push for researchers to divest from and seek alternatives to fetal cell cultures as well.

For some pro-life bioethicists, the vast distance between the harm of the original abortion and the use of the modern treatment in which it resulted means that, while policymakers and biotech firms still have a moral obligation to work toward developing ethically unproblematic alternatives, individuals dont necessarily have a moral duty to abstain from such treatments themselves. Medical ethics are complicated and a matter of conscience, said Tiffany Manor, who directs the Life Ministry of the conservative Lutheran ChurchMissouri Synod. Some modern medical procedures result from past research that was conducted unethically. That doesnt mean that we ought to throw out all of the beneficial procedures.

But others argue that individuals retain a moral duty to keep pressure on the medical research industry by declining the use of such treatments when possible without creating grave risks to public health. The Catholic Churchs Pontifical Academy for Life tried to strike such a balance when it considered the question in 2005:

On a cultural level, the use of such vaccines contributes in the creation of a generalized social consensus to the operation of the pharmaceutical industries which produce them in an immoral way. Therefore, doctors and fathers of families have a duty to take recourse to alternative vaccines (if they exist), putting pressure on the political authorities and health systems so that other vaccines without moral problems become available. They should take recourse, if necessary, to the use of conscientious objection with regard to the use of vaccines produced by means of cell lines of aborted human foetal origin.

The document goes on:

As regards the diseases against which there are no alternative vaccines which are available and ethically acceptable, it is right to abstain from using these vaccines if it can be done without causing children, and indirectly the population as a whole, to undergo significant risks to their health.

You can see the precarious moral tightrope here: It is good, in the mind of pro-life ethicists, to attempt as much as possible not to participate, however indirectly, in the evil act of a long-ago abortion. But one ought not strain so hard to avoid that participation that one thoughtlessly commits another evil act: allowing oneself or ones children to become vectors of otherwise preventable disease, spreading suffering and even death to those around them.

All this, remember, is just the moral calculus that surrounds such vaccine under normal medical circumstances. Throw in a global pandemic and an unprecedented race to treat and cure it, and you begin to get a sense of the scale of the ethical headaches involved.

Take the issue of Regeneron. Since his own positive experience with the companys antibody cocktail, REGN-COV2, President Trump has become its biggest cheerleader; pushing for it to play a major role in COVID treatment going forward. We have hundreds of thousands of doses that are just about ready. I have emergency use authorization all set, he said on October 7. Youre gonna get better, and youre gonna get better really fast.

But both Regenerons drug and a similar antibody treatment currently being developed by Eli Lilly made use of fetal tissue in their developmentnot in the actual manufacture of the drug, as mentioned above, but in creating neutered pseudoviruses to test its effectiveness.

Imagine a person whose doctor has recommended such a drug trying to make a decision in the light of the moral principles suggested by the Pontifical Academy for Life. On the one hand, the drug is a product of fetal tissue research in only the most remote possible way. But the possibility of endangering others by abstaining does not bear considering here, as the cocktail is a treatment, not a vaccine. Further, it is unclear how a person recommended such a treatment by a doctor ought to think about the question of whether there are ethically acceptable alternatives. Other drugs can help manage COVID, of course, but generally speaking their effect is cumulative: Dexamethasone and remdesivir are not replacements for antibody therapy.

To cap the dilemma off, it isnt as though a pro-life person could start off with unproblematic treatments and work up to REGN-COV2 as a matter of last resort: Patients arent prescribed antivirals or steroids for COVID unless theyre already seriously sick, while antibody treatments like Regenerons have been shown to be helpful only if theyre given very early in the course of the disease, before the bodys own immune response has had a chance to kick in.

COVID vaccines in development present further difficulties. First, we dont actually know which of the many vaccines currently being developed will end up the first to pass muster as a safe, effective, and mass-producible weapon against the pandemic. Many of the candidates do not make use of fetal-derived cells in any capacity. Others use such cells only in confirmatory tests, as with Regeneron. Still others use them in the production of the vaccines themselves.

Of the four vaccines seemingly closest to release in America, twothose being developed by Pfizer and Modernawere merely tested on fetal-derived cells. Two others, from Johnson & Johnson and AstraZeneca, are made with them. The latter vaccines Phase III clinical trials were placed on hold earlier this month, but were resumed last week.

Under ordinary circumstances, this would be a no-brainer: Many pro-life people would simply wait for one of the less objectionable vaccines to become available. But during the coronavirus pandemic, where every day that goes by without a vaccine is critical, what happens if Johnson & Johnson or AstraZenecas product is first past the post, and the federal government invests heavily in its development and distribution?

Its unclear whether such a situation would provoke a legal clash. The federal government doesnt have the constitutional authority to mandate vaccines, but states and cities can; all 50 states require children to receive a battery of vaccines before attending public school, although all offer various exemptions for religious, philosophical, and/or other reasons. Whether citizens have a right to such exemptions, however, is less clear: the Supreme Court has upheld mandatory vaccination programs in the past and has separately ruled that the right to practice religion freely does not include liberty to expose the community or the child to communicable disease.

Theres no reason to believe yet that states will choose to go that route. New York Gov. Andrew Cuomo, whose state was racked by the coronavirus this spring and who last year signed a state law ending religious exemptions for childhood vaccines, is thus far messaging that an eventual COVID vaccine will be available to all New York residents who want one.

The likelier scenario may be that such a clash will instead simply play out in the court of public opinion.

One of the nightmare scenarios Ive been thinking about is, say we get a safe and effective vaccine, and it comes from what many would regard as tainted sources, said Mitchell. And so pro-lifers decide not to use the vaccinethey wont be vaccinated. My guess is that there would be a huge uprising in the society saying, Well, youre posing now a public health risk. We now have a vaccine, but youre choosing not to use it. Youre exposing others to it by not taking the vaccine, or youre going to cost our health care system huge amounts of money in treating you when we have a vaccine that could prevent getting COVID-19, but you choose not to. So I think those are going to be an important test of our convictions.

Photograph by Paul Hennessy/NurPhoto/Getty Images.

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Is the Pro-Life Movement on a Collision Course with the Coronavirus? - The Dispatch

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