West Virginia midterm elections: What to know about voting in Mon County – The Daily Athenaeum – thedaonline

Posted on by

Election season is here, and West Virginians will soon cast their ballots for a number of county, state and federal offices, as well as four proposed amendments to the state constitution.

Tuesday, Oct. 18, is the voter registration deadline in West Virginia to participate in the 2022 midterm elections. Early voting will take place from Oct. 26 to Nov. 5.

Heres what you need to know about voting in Monongalia County.

You can verify your voter registration status on the Secretary of States website by entering your full name and birthdate. From there, you can see your voter status, party affiliation, political district and polling location.

The deadline to register to vote in West Virginia is Tuesday, Oct. 18.

You can register online, by mail or in person by providing a valid ID and the last four digits of your Social Security number. Your county clerk should notify you once your application has been processed.

If you dont have a driver's license or access to your Social Security number, you can create a voter application online and deliver a signed copy to your county clerk by mail or in person.

If this is your first time registering to vote in the state, youll be required to show valid identification when registering and voting for this election. Heres a full list of acceptable IDs.

To qualify for voter registration in West Virginia, you must be a U.S. citizen and 18 years or older. You must also have a physical address in the state.

You cannot register to vote in the state if youve been convicted of a felony and are still serving a sentence, including probation or parole, or if youve been deemed mentally incapacitated by the court of law.

Heres more information on voter eligibility.

Yes, anyone in West Virginia can update their voter registration on the Secretary of State's website.

In-state students can change their voting district by providing a physical address, including college dorms and apartments.

Out-of-state students can register to vote in the state as well by providing a physical address and a valid ID. However, these students are strongly encouraged to cancel their out-of-state registration while voting in West Virginia, according to Donald Kersey, deputy legal counsel for the Secretary of State.

Although its not illegal to be registered to vote in two states, voting on two different ballots is a felony in West Virginia, according to the State Code.

In West Virginia, you can vote in person or by mail, though you must meet certain eligibility requirements.

If youre voting in person, you can confirm your polling location with the Secretary of State.

For absentee voting, you must fill out a ballot application and submit it to the county clerk at least six days before the election (Nov. 2, 2022).

Track your absentee ballot here.

A number of county, state and federal offices will be on the ballot in the November general election.

All West Virginians will vote for members of the U.S. House of Representatives, state delegates and state senators.

Offices in both the states House of Delegates and Senate are also up for grabs, with all previous position-holders running for re-election. Ballots will vary for voters based on districts and precincts.

Additionally, local elections for the Monongalia County Commission, Clerk and Circuit Clerk will also take place on Nov. 8. Both the candidate for the County Clerk and the County Circuit Clerk will run unopposed, whereas the race for the County Commission has two candidates, Democrat Bob Beach and Republican Sean Sikora.

You can look up a sample ballot on the Secretary of States website.

Voters will also be asked to weigh in on four different amendments to the states constitution, regarding tax, religion, education and impeachment.

Amendment 1: Judiciary Role in Impeachment

The first proposed amendment is aimed to clarify the Judiciarys role in impeachment proceedings and thereafter.

Currently, any state official, in either the House of Delegates or the Senate, may be impeached for a number of reasons, including but not limited to the neglect of duty, corruption or a high crime or misdemeanor. The House holds the power to impeach while the Senate is responsible for trying.

This amendment would assert that the Judiciary and its courts have no power to interfere or intervene with any impeachment proceeding of the House or Senate. The Judiciary is also prohibited from reviewing a judgment in the House or Senate regarding an impeachment.

Amendment 2: Property Tax

The proposed amendment on how much power the state should maintain over taxation may be the most controversial.

The second and most controversial amendment would permit the state to give tax cuts and exemptions for personal property taxes on tangible machinery, equipment and inventory used for business practices. It would also exempt the personal motor vehicle tax from ad valorem property taxes, which means that the tax is proportional to the value of the transaction or the property being taxed.

According to the West Virginia Center for Budget & Policy, the proposed amendment would give the legislature control over 27% of personal property taxes in the state.

Amendment 3: Incorporation of Churches

The third amendment discusses the incorporation of churches or religious denominations. This would allow for provisions to be made through general laws for securing, selling or transferring the title of a church property for purposes of the church or religious denominations.

Currently, West Virginia is the only state that prohibits any charter of incorporation to be granted to any church or religious denomination, as the provision was inherited from Virginias constitution when the state seceded. Allowing churches and religious denominations to incorporate would make it easier for them to borrow and manage money.

Amendment 4: Board Education

Lastly, the fourth amendment would clarify that any rule or policy enacted by the State Board of Education is subject to legislative review, approval, amendment or rejection. After the BOE creates a rule or policy, it must be submitted for review.

This means the state Legislature would give the final ruling over any proposed BOE rule or policy change.

View post:

West Virginia midterm elections: What to know about voting in Mon County - The Daily Athenaeum - thedaonline

HIGHPEAK ENERGY, INC. : Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance…

Posted on by

Item 1.01 Entry into a Material Definitive Agreement.

On October 14, 2022 (the "Fifth Amendment Effective Date"), HighPeak Energy,Inc. (the "Company"), as borrower, Fifth Third Bank, National Association, asthe existing administrative agent (the "Existing Agent"), Wells Fargo Bank,National Association, as the new administrative agent (the "New Agent"), theguarantors party thereto and the lenders party thereto entered into that certainFifth Amendment to Credit Agreement (the "Credit Agreement Amendment"), which,upon effectiveness, amended that certain Credit Agreement, dated as of December17, 2020 (as amended, restated, amended and restated, supplemented or otherwisemodified by (i) that certain First Amendment to Credit Agreement, dated as ofJune 23, 2021, (ii) that certain Second Amendment to Credit Agreement, dated asof October 1, 2021, (iii) that certain Third Amendment to Credit Agreement,dated as of February 9, 2022, (iv) that certain Fourth Amendment to CreditAgreement, dated as of June 27, 2022 and (v) the Credit Agreement Amendment,(the "Credit Agreement")), among the Company, Fifth Third Bank, NationalAssociation, as administrative agent, the guarantors party thereto and thelenders party thereto to, among other things, (i) increase the electedcommitments to $525 million and the borrowing base to $550 million, (ii) requirean additional borrowing base redetermination on or about December 1, 2022, (iii)modify the permitted dividends and distributions conditions such that minimumavailability under the credit facility must be 25% percent (as opposed to 30%before giving effect to the Credit Agreement Amendment) and (iv) appoint the NewAgent as the replacement administrative agent to replace the Existing Agent.

In addition, in connection with the Credit Agreement Amendment, to the extentthe Company incurs any additional specified unsecured senior, seniorsubordinated or subordinated future indebtedness between the Fifth AmendmentEffective Date and June 30, 2023, the Company's obligation to reduce theborrowing base by an amount equal to 25% of the principal amount of suchadditional future indebtedness shall be waived. In connection with the CreditAgreement Amendment, the lenders waived two technical events of default existingwith the Credit Agreement, as it existed prior to giving effect to the CreditAgreement Amendment, related to entering into and maintaining certain minimumhedges as of the fiscal quarters ending June 30, 2022 and September 30, 2022 andcomplying with the required current ratio as of the fiscal quarter endingSeptember 30, 2022.

The foregoing description of the Credit Agreement Amendment is qualified in itsentirety by reference to the Credit Agreement Amendment, a copy of which isattached hereto as Exhibit 10.1 and is incorporated by reference.

Item 2.03 Creation of a Direct Financial

The information set forth under Item 1.01 above is hereby incorporated into thisItem 2.03 by reference.

Item 7.01 Regulation FD Disclosure.

The Company issued a press release on October 18, 2022 announcing that onOctober 18, 2022 it had entered into the Credit Agreement Amendment. A copy ofthe press release is included as Exhibit 99.4 hereto and incorporated byreference.

The information furnished pursuant to this Item 7.01 shall not be deemed to be"filed" for purposes of Section 18 of the Securities Act and will not beincorporated by reference into any filing under the Securities Act, unlessspecifically identified therein as being incorporated therein by reference.

Item 9.01 Financial Statements and Exhibits.

--------------------------------------------------------------------------------

Edgar Online, source Glimpses

Here is the original post:

HIGHPEAK ENERGY, INC. : Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance...

Eugenics: Its Origin and Development (1883 – Present)

Posted on by

Timeline select a year for more details

Francis Galton (pictured), Charles Darwins cousin, derived the term eugenics from the Greek word eugenes, meaning good in birth or good in stock. Galton first used the term in an 1883 book, Inquiries into Human Fertility and Its Development. Francis Galton (pictured), Charles Darwins cousin, derived the term eugenics from the Greek word eugenes, meaning good in birth or good in stock. Galton first used the term in an 1883 book, Inquiries into Human Fertility and Its Development.

We greatly want a brief word to express the science of improving stock, which is by no means confined to questions of judicious mating, but which, especially in the case of man, takes cognizance of all influences that tend in however remote a degree to give to the more suitable races or strains of blood a better chance of prevailing speedily over the less suitable than they otherwise would have had. The word eugenics would sufficiently express the idea.

Galton believed that eugenics could control human evolution and development. In his writings, he argued that abstract social traits, such as intelligence, were a result of heredity. In his book, he claimed that only higher races could be successful. Galtons writings reflected prejudiced notions about race, class, gender and the overwhelming power of heredity.

Link:

Eugenics: Its Origin and Development (1883 - Present)

Eugenics – HISTORY

Posted on by

Contents

Eugenics is the practice or advocacyof improving the human species by selectively mating people with specific desirable hereditary traits. It aims to reduce human suffering by breeding out disease, disabilities and so-called undesirable characteristics from the human population. Early supporters of eugenics believed people inherited mental illness, criminal tendencies and even poverty, and that these conditions could be bred out of the gene pool.

Historically, eugenics encouraged people of so-called healthy, superior stock to reproduce and discouraged reproduction of the mentally challenged or anyone who fell outside the social norm. Eugenics was popular in America during much of the first half of the twentieth century, yet it earned its negative association mainly from Adolf Hitlers obsessive attempts to create a superior Aryan race.

Modern eugenics, more often called human genetic engineering, has come a long wayscientifically and ethicallyand offers hope for treating many devastating genetic illnesses. Even so, it remains controversial.

Eugenics literally means good creation. The ancient Greek philosopher Plato may have been the first person to promote the idea, although the term eugenics didnt come on the scene until British scholar Sir Francis Galton coined it in 1883 in his book, Inquiries into Human Faculty and Its Development.

In one of Platos best-known literary works, The Republic, he wrote about creating a superior society by procreating high-class people together and discouraging coupling between the lower classes. He also suggested a variety of mating rules to help create an optimal society.

For instance, men should only have relations with a woman when arranged by their ruler, and incestuous relationships between parents and children were forbidden but not between brother and sister. While Platos ideas may be considered a form of ancient eugenics, he received little credit from Galton.

In the late 19th century, Galtonwhose cousin was Charles Darwinhoped to better humankind through the propagation of the British elite. His plan never really took hold in his own country, but in America it was more widely embraced.

Eugenics made its first official appearance in American history through marriage laws. In 1896, Connecticut made it illegal for people with epilepsy or who were feeble-minded to marry. In 1903, the American Breeders Association was created to study eugenics.

John Harvey Kellogg, of Kellogg cereal fame, organized the Race Betterment Foundation in 1911 and established a pedigree registry. The foundation hosted national conferences on eugenics in 1914, 1915 and 1928.

As the concept of eugenics took hold, prominent citizens, scientists and socialists championed the cause and established the Eugenics Record Office. The office tracked families and their genetic traits, claiming most people considered unfit were immigrants, minorities or poor.

The Eugenics Record Office also maintained there was clear evidence that supposed negative family traits were caused by bad genes, not racism, economics or the social views of the time.

Eugenics in America took a dark turn in the early 20th century, led by California. From 1909 to 1979, around 20,000 sterilizations occurred in California state mental institutions under the guise of protecting society from the offspring of people with mental illness.

Many sterilizations were forced and performed on minorities. Thirty-three states would eventually allow involuntary sterilization in whomever lawmakers deemed unworthy to procreate.

In 1927, the U.S. Supreme Court ruled that forced sterilization of the handicapped does not violate the U.S. Constitution. In the words of Supreme Court Justice Oliver Wendall Holmes, three generations of imbeciles are enough. In 1942, the ruling was overturned, but not before thousands of people underwent the procedure.

Scroll to Continue

In the 1930s, the governor of Puerto Rico, Menendez Ramos, implemented sterilization programs for Puerto Rican women. Ramos claimed the action was needed to battle rampant poverty and economic strife; however, it may have also been a way to prevent the so-called superior Aryan gene pool from becoming tainted with Latino blood.

According to a 1976 Government Accountability Office investigation, between 25 and 50 percent of Native Americans were sterilized between 1970 and 1976. Its thought some sterilizations happened without consent during other surgical procedures such as an appendectomy.

In some cases, health care for living children was denied unless their mothers agreed to sterilization.

As horrific as forced sterilization in America was, nothing compared to Adolf Hitlers eugenic experiments leading up to and during World War II. And Hitler didnt come up with the concept of a superior Aryan race all on his own. In fact, he referred to American eugenics in his 1934 book, Mein Kampf.

In Mein Kampf, Hitler declares non-Aryan races such as Jews and gypsies as inferior. He believed Germans should do everything possible, including genocide, to make sure their gene pool stayed pure. And in 1933, the Nazis created the Law for the Prevention of Hereditarily Diseased Offspring which resulted in thousands of forced sterilizations.

By 1940, Hitlers master-race mania took a terrible turn as hundreds of thousands of Germans with mental or physical disabilities were euthanized by gas or lethal injection.

During World War II, concentration camp prisoners endured horrific medical tests under the guise of helping Hitler create the perfect race. Josef Mengele, an SS doctor at Auschwitz, oversaw many experiments on both adult and child twins.

He used chemical eyedrops to try and create blue eyes, injected prisoners with devastating diseases and performed surgery without anesthesia. Many of his patients died or suffered permanent disability, and his gruesome experiments earned him the nickname, Angel of Death.

In all, its estimated eleven million people died during the Holocaust, most of them because they didnt fit Hitlers definition of a superior race.

Thanks to the unspeakable atrocities of Hitler and the Nazis, eugenics lost momentum in after World War II, although forced sterilizations still happened. But as medical technology advanced, a new form of eugenics came on the scene.

Modern eugenics, better known as human genetic engineering, changes or removes genes to prevent disease, cure disease or improve your body in some significant way. The potential health benefits of human gene therapy are staggering since many devastating or life-threatening illnesses could be cured.

But modern genetic engineering also comes with a potential cost. As technology advances, people could routinely weed-out what they consider undesirable traits in their offspring. Genetic testing already allows parents to identify some diseases in their child in utero which may cause them to terminate the pregnancy.

This is controversial since what exactly constitutes negative traits is open to interpretation, and many people feel that all humans have the right to be born regardless of disease, or that the laws of nature shouldnt be tampered with.

Much of Americas historical eugenics efforts such as forced sterilizations have gone unpunished, although some states offered reparations to victims or their survivors. For the most part, though, its a largely unknown stain on Americas history. And no amount of money can ever repair the devastation of Hitlers eugenics programs.

As scientists embark on a new eugenics frontier, past failings can serve as a warning to approach modern genetic research with care and compassion.

American Breeders Association. University of Missouri.Charles Davenport and the Eugenics Record Office. University of Missouri.Forced Sterilization of Native Americans: Late Twentieth Century Physician Cooperation with National Eugenic Policies. The Center for Bioethics & Human Dignity.Greek Theories on Eugenics. Journal of Medical Ethics.Josef Mengele. Holocaust Encyclopedia.Latina Women: Forced Sterilization. University of Michigan.Modern Eugenics: Building a Better Person? Helix.Nazi Medical Experiments. Holocaust Encyclopedia.Plato. Stanford Encyclopedia of Philosophy.Unwanted Sterilization and Eugenics Programs in the United States. PBS.

Follow this link:

Eugenics - HISTORY

150000 Black Women Were Forced Into the Eugenics Program – History of Yesterday

Posted on by

ince the start of eugenics in the 19th century, it has been one of the most debated ideologies within modern history, at least from an ethical perspective. The idea of human sterilization was invented by British explorerFrancis Galton who was inspired by Charles Darwins theory of natural selection. Due to the rise of hereditary diseases, natural selection in his eyes seemed like the best medical practice in combating these diseases and a way to remove these diseases for future generations.

During the same period of time, people around the world started to combat racism and fight for human equality as one racial prejudice seen among minorities was the higher chance of diseases or hereditary diseases being spread although medicine within the 19th century didnt permit an accurate check of hereditary diseases within ones organism.

The world of medicine (especially western) has its own section of racial prejudice where it seems to treat patients of different color differently, as if they are a totally different species, presenting (in the eyes of the western doctors at the time) more vulnerability towards hereditary diseases whilst having a higher resilience to pain, as presented in some of my works: The Myth of Black People Not Feeling Pain Is Still Believed to This Day

The biggest efforts for the eugenics program took place in America and mostly pointed toward African American and Hispanic citizens as well as mainly towards the female population. In my eyes, taking away a womans ability to give birth is pretty much like taking away her femininity and the most beautiful gift that God has given to women.

The 20th century was a long-lasting fight for the African American citizens of the United States as well as other minority groups that were seen as different due to their physical appearance. Racial prejudice and the fight for equality had become the tensest during the 1960s, especially with Martin Luther Kings movement within the United States.

Sterilization within the United States publicity began around the 1910s, and aimed to be applied by all the States of America. Although it was very much supported by the government, this program was very much influenced by racial groups such as theNeo-Malthusianswho believed that the world is overpopulated and that is what will lead to its ecological collapse.

By 1913 many norther states were already allowed by law to perform eugenics sterilization purely based on eugenic motives (avoidance of hereditary diseases).By 1913, many states had or were on their way to having eugenic sterilization laws. (Source: Boston Medical Library)

Within the eugenics program, their idea was that poverty is created due to overpopulation, and since most African Americans at the time were part of the lower class, it should be them to be sterilized above everyone else. The focus was not just on poverty, but on the finest genes and having the finest baby be born. The white population within America really made a big thing out of it by even having contests such as the Fitter Family contest or Better Baby contests.

The idea was not so much focused on creating or having the perfect race, but more like developing and reproducing the perfect white human.

At first, the group focused more on educating people below the poverty line aboutcontraceptives and sexual education. Seeing that it wasnt working, the people within the group being quite powerful, influenced the government towards a eugenics program (amongst many other external influencers).

The population was really easy to influence and indoctrinate with the idea behind the eugenics program, especially with the rise of all diseases and epidemics within the US during the 20th century. Another issue was that the population didnt really understand with exactitude in what conditions hereditary disease can be transmitted. This gave them another reason to become more racially inclined in the late 1940s and approve on an ethical level of the eugenics program when it came to people of a different color.Hereditary Genius 1869 by Francis Galton (Source: The British Library)

People did not care about the history of eugenics, such as the use of eugenics by the Nazis to remove the Jewish population within Germany in the late 1930s, early 1940s, something which also focused on the correlation between eugenics and racism. The idea of human sterilization started by Francis Galton has racism at its pillars, as with the idea of eugenics,he wanted to create the perfect race, this argument is presented by him in his bookHereditary Geniuspublished in 1869.

Since 1933 and up to 1974, between 100,000 and 150,000 black women have taken part within the eugenics program, most of them being forced and threatened by doctors and other racist groups. A small number were actually persuaded to deliberately take part in the program with small incentives or via other persuasive means. This is very much an argued number as many of the women that took part were forced and done off the record.

What is even more interesting is that the eugenics program continued even after forcing people into the eugenics program became illegal within the United States in 1974. This just adds up to the long list of human rights that have been taken from women of color within America, but the main focus should be on how the world was ok with eugenics in the first place.

Forceful sterilizationstill endures today within America, mainly in female prisons. A survey taken in 2011 by the state of California showed thatbetween 1997 and 2010 approximately 1,400 women within California prisons were forcedinto the eugenics program.

Having the ability to give life is the most human ability in my opinion, just like everything in this world has the right to reproduce and retain its legacy, so we should all. Sadly, knowing that forceful eugenics still takes place in some parts of the world and seeing the world wanting to take away a womans ability to give birth just makes me want to lose hope in humanity.

More here:

150000 Black Women Were Forced Into the Eugenics Program - History of Yesterday

SURPLUS The New Inquiry – The New Inquiry

Posted on by

Theproduction of death under capitalism is well understood. Innumerable terms and theoretical formulations exist to define the endpoint of capitals immiseration, the one constant to human life that our political economy is particularly adept at expediting. Social murder is the term used by Engels and his contemporaries. Its deed is murder just as surely as the deed of the single individual; disguised, malicious murder, murder against which none can defend himself, which does not seem what it is, because no man sees the murderer, because the death of the victim seems a natural one, since the offence is more one of omission than of commission. Likewise statistical genocide, or democide. Lauren Berlant called this slow deathmass physical attenuation under global/national regimes of capitalist structural subordination.

The finality of death in the social imaginary as the ultimate conclusion of capitals violence can produce fantasies of a moral or ethical capitalism. This is arguably the dream chased by capitals true believers: with modifications to its systems, we can slow slow death to a crawl, render statistical genocide statistically insignificant. With premature death the imagined enemy of capitals internal narrative of its own beneficence, minor reforms become enshrined as a legible mirage. But the primary sites of violence under capitalism are not those that lead directly to death. They are instead the quotidian forms that situate capitalist belonging; the reproduction of norms socially as well as legally and administratively, abetted by a cynical din of knowledge production that institutionalizes logics of eugenics and austerity.

For this reason, we focus not on how capitalism reproduces death but on how and why capital keeps you alive. We consider what is elsewhere called administrative violence; in the words of Dean Spade, how law structures and reproduces vulnerability. We follow how those marked as vulnerable by administrative violence are not only immiserated, but also become the object of capital accumulation.

Central to this is the figure of the surplus population(s), the necessarily amorphous and indefinable category that is the focus of our project. How the political economy has evolved in the last century to maximize its exploitation of the surplus populationspathologizing with one hand while generating capital with the otheris a process that must be understood by those mobilizing for health justice or health communism, and to begin to imagine a world free of the eugenic philosophy of capitalism. It is toward this understanding that Health Communism begins.

The surplus population was initially defined in economic terms in separate writings by Engels and Marx in response to the moralizing, demographic panics of industrial capitalisms early philosophers, among them Adam Smith and Robert Malthus. (Smith: The demand for men, like that for any other commodity, necessarily regulates the production of men; Malthus: A distinction will in this case occur, between the number of hands which the stock of society could employ, and the number which its territory can maintain.) Both Engels and Marx, in referring to the surplus populations as capitals general reserve army, make clear that their formulation has to do in large part with the population of unemployed people who could otherwise be a part of the labor force. Engels refers to the surplus populations as keep[ing] body and soul together by begging, stealing, streetsweeping. . . It is astonishing in what devices this surplus population takes refuge.

Health, disability, and debility are largely absent from early discourses around the surplus populations that Marx and Engels responded to, except in cases of characteristic pathologizing of the poor. (Malthus again: The labouring poor . . .seem always to live from hand to mouth. Their present wants employ their whole attention, and they seldom think of the future.) Engels and Marx do, however, share concerns for the public health of the surplus population and the disablement wrought by industrial production. Engels The Condition of the Working Class in England can be regarded as an early work of social epidemiology, locating capitals impact on the social determinants of health just as the idea of public health was at its formation. Marx notes of the relationship between health, private sector industrialization, and the state, that

health officers, the industrial inquiry commissioners, the factory inspectors, all repeat, over and over again, that it is both necessary for [factory] workers to have these 500 cubic feet [of space per person], and impossible to impose this rule on capital. They are, in reality, declaring that consumption and the other pulmonary diseases of the workers are conditions necessary to the existence of capital.

A contemporary understanding of what it is to be surplus is necessarily more expansive. Major societal shifts in the late modern period, discussed at length in our chapter LABOR, solidified the worker/surplus binary in public consciousness in part by incorporating a conception of workers health or disability as a central facet in their certification as surplus.

The surplus, or surplus populations, can therefore be defined as a collective of those who fall outside of the normative principles for which state policies are designed, as well as those who are excluded from the attendant entitlements of capital. It is a fluid and uncertifiable population who in fact should not be rigidly defined, for reasons we discuss below. Crucially, this definition also elides traditional left conceptions of the working class or the worker. As we will describe at length throughout Health Communism, the idea that the worker is not a part of the surplus populations, yet faces constant threat of becoming certified as surplus, is one of the central social constructions wielded in support of capitalist hegemony. Similarly, the methods the state employs to certify delineations between surplus populations constitute effective tactics in maintaining this hegemony. An understanding of the intersectional demands of those subjected or excluded by capital constitutes the potential for building solidarity, which is definitionally a threat to capital. An understanding that the marking and biocertification of bodies as non-normative or surplus constitutes a false, socially constructed imposition of negative value is also a threat to capital. An understanding that illness, disability, and debility are driven by the social determinants of health, with capital as the central social determinant, itself constitutes such a threat. We argue therefore that in order to truly mount a challenge to capitalism it is necessary that our political projects have and maintain the surplus at their center.

While the surplus population does contain those who are disabled, impaired, sick, mad, or chronically ill, the characteristic vulnerability of the surplus is not inherent to their existencethat is, it is not any illness, disability, or pathologized characteristic that itself makes the surplus vulnerable. Their vulnerability is instead constructed by the operations of the capitalist state. The precarity of the surplus population is made through what Ruth Wilson Gilmore calls organized abandonment, the deliberate manipulation and disproportionate dispossession of resources from Black, Brown, Indigenous, disabled, and poor communities, rendering them more vulnerable to adverse health.

Understanding the shifting social constructions of surplus under capitalism, and the organization of this organized abandonment, is uniquely illustrative of the imbrication of health and capital. At the time of its initial formulation, surplus populations are largely discussed in the sense of surplus constituting superfluous (another term wielded synonymously for this population at the time) or otherwise irrelevance, waste. We can see this literalized in early American labor benefits: the few national unions that offered a permanent disability benefit paid a sum equal to the meager benefit a workers family would receive on the workers death. A worker becoming disabled thus not only constitutively passed the boundary from worker to surplustheir social value following disablement was, effectively, as good as dead.

This categorization and certification of surplus has become a focal struggle in the history of capitalism, socially reproducing a collective imaginary of who is a worker, who is property, and who is surplusand to what degree of personhood each category is entitled under the scope of law. Those who are deemed to be surplus are rendered excess by the systems of capitalist production and have been consequently framed as a drain or a burden on society. But the surplus population has become an essential component of capitalist society, with many industries built on the maintenance, supervision, surveillance, policing, data extraction, confinement, study, cure, measurement, treatment, extermination, housing, transportation, and care of the surplus. In this way, those discarded as non-valuable life are maintained as a source of extraction and profit for capital.

This rather hypocritical stancethe surplus are at once nothing and everything to capitalismis an essential contradiction Liat Ben-Moshe identifies this characteristic through the intersection of disability and incarceration: Surplus populations are spun into gold. Disability is commodified through [a] matrix of incarceration (prisons, hospitals, nursing homes). Jasbir Puar, in The Right to Maim: Debilitation and the production of disability are in fact biopolitical ends unto themselves . . . Maiming is a source of value extraction from populations that would otherwise be disposable.

Inmuch of the following, we situate our analysis of the social construction of surplus through the lens of disability, as one of the many contingent embodiments of surplus identities. Disability not only operates as one perceived extreme of the worker/surplus binary but is also understood within the capitalist political economy as constituting, or at least including, a state of being irremediably ill or unwell. In this sense, it is a total ideological reduction of the subject into a valuation of what role they are certified as capable to adopt under capitalism. Far from being left as an abstract category, the state, including the constituent social-reproductive apparatuses upholding it, has developed over time an array of tools to certify the exact boundaries of what qualifies an individual as surplus. For the surplus, this regime of biocertification shapes both how the state interacts with them and the boundaries of their participation in social life. In Fantasies of Identification, Ellen Samuels analyzes how certain forms of state assistance, resource allocation, or support are often understood within the popular imaginary as a kind of currency. These benefits are gatekept by abstract bureaucratic systems of eligibility predicated on the verifiability of someones biological state and identity. As such, Samuels argues, the role of biocertification, namely the process of assuring that only legitimate claimants receive this currency-in-kind, is reinscribed with a simulated social banking function, reinforcing the idea that the process of biocertification itself is an efficient means of allocating economic resources. Biocertification is assumed to be a necessary gatekeeping mechanism or checkpoint to prevent the wasting of resources on fakers, cheats, imposters, and malingerers: invoking both a model of scarcity, in which resources must be reserved for those who truly deserve them, and a distrust of self-identification, in which statements of identity are automatically suspect unless and until validated by an outside authority.

The generosity of these currencies-in-kind is often extraordinarily overstated in the social-reproductive imaginary. Cultural perceptions dictate a picture of disability, illness, and marginalization which is not reflective of the material gains that come as a result of being biocertified for social welfare supports like the United States Social Security Disability Insurance (SSDI) or Medicare/Medicaid. This is what Samuels describes as a tendency to commonly perceive these [eligible] identities as lucrative commodities. The boundaries and borders of qualification are guarded by a combined medical-legal authority and rest on the understanding that identities are readily measurable, verifiable, and fixed, ascribing meaning to biological observation and institutions of authority which seek to standardize the line between social citizenship and exclusion.

This constructed preference for standardization and biocertification arises out of the imbrication of health and capital. If the economy of health is to be bled for excess profit, then the fundamentally inefficient process of facilitating our mutual survival must be made to be efficient. The modern welfare state measures and quantifies metrics of individual health against a picture of the individuals economic resources and labor power in order to restrict the administration of aid. To determine eligibility for SSDI in the United States, for example, the Social Security Administration (SSA) uses formulas and charts to transform bodily conditions into percentages of ability. Physical conditions of the body and its organs are clinically evaluated to determine their relative distance or deviance from an abstract ideal normal body (worker). To the SSA, all impairments, symptoms, circumstances, and conditions are of equal value and attention; all health is equally neutral. This is because the severity of illness, impairment, or disability is not actually the metric the SSA uses to determine eligibility. The crucial axis is instead the individuals relationship to work. What emerges from these phenomena is a shadow biocertification regime that hides in plain sight as a means test to ward off would-be waste, fraud, and abuse. Labor power is equated to bodily state, and health is measured through this contradictory lens.

To the SSA, illness is only relevant in relation to whether and to what degree it impacts a persons capacity to work. As Rosemarie Garland Thompson argues, this presumes that ill-health, disability, and impairment are located only in the body and not also in the broader social, political, and geographical context that comprises the individuals social determinants of health. Impairments and disabilities are reduced to numbers on a page: On one scale, for example, limb amputation translates as a 70% reduction in ability to work, while amputation of the little finger at the distal joint reduces the capacity for labor by a single percentage point. Garland Thompsons critique of the disability eligibility schema in the US questions the ability of the state to meaningfully measure such complex and dynamic situations as a persons health and worth using a precise mathematical relation. Labor power, social and material conditions, and bodily states are collapsed into a single metric, measuring all health along a continuum of relative currency.

The ideological framing of wage work as a mitigating factor in an individuals eligibility for health and welfare benefits attempts to map economic valuations of life onto regimes of biocertification, as is readily evident in SSDI determinations. Social Security disability eligibility is a legal process of decertifying a body for work, not the certification of a body for any type of qualifying disability or impairment demonstrating need for care and additional social supports. These notions have become replicated in social security and social insurance programs internationally. Countless states limit or adjust their benefits dependent on the amount of productive labor the individual has already participated in during their life. This has become particularly prevalent alongside the spread of social insurance privatization schemes by international financial firms, as discussed at length in BORDER.

The authority of medical opinion is widely used as a means to measure the truth of a bodys impairment and certify to the states satisfaction that the benefit applicant is truly biologically incapable for work, through no fault of their own. This arguably subjective perspective of medical authority is treated as if it is a visible and clearly quantifiable fact. The state relies upon the signifier of medical authority as a means of depersonalizing and depoliticizing the biocertifi cation process writ large. Relying on claimed scientific or medical frameworks, biocertification schemes seek to identify and sort bodies, placing each within the context of their correct category, which is reflective of the intersections of their race, gender, citizenship, wealth, or ability, as a means of validating the social truth of a persons identity. This framework assumes that a persons biological identity can in fact be scientifically measured, rendering their ultimate categorization or eligibility as if depoliticizeda procedural, objective, binary decision. An individuals material conditions or identity cannot be understood as in any way fluid or abstract under this biocertification preference. Existing outside of certification means categoric exclusion.

Biocertification regimes assume that validating characteristics are readily obvious or apparent, falling squarely in the category of common sense generalizations, meaningful or not, about various observed metrics. Despite little scientific basis, strategies of biocertification are treated as fact and reinscribed through law and policy, leveraging medical authority to consolidate the power of the state to determine life chanceswho lives and who dies. Importantly, none of this is to say that states of being, conditions, ailments, and so on do not exist. Far from it. Instead, it is to say that the intersection of those conditions of healthor simply of being, of states of existencehave become of signifi cant use to capital in its demarcation of ontological boundaries within society and the resulting distribution of resources. Resisting biocertification does not mean resisting diagnosis or identification. It means resisting the leveraging of these certifications by capital and the state.

***

Health Communism by Beatrice Adler-Bolton and Artie Vierkant is now available from Verso.

More here:

SURPLUS The New Inquiry - The New Inquiry

A Desire to Cure, Not to Punish: Women Physicians and Eugenics in the American West, 19001930 by Jacqueline D. Antonovich – Smith College Grcourt Gate

Posted on by

Thursday, October 13, 5p.m., Graham Hall, Brown Fine Arts Center

Jacqueline D. Antonovich is Assistant Professor of History at Muhlenberg College. Professor Antonovich is a historian of health and medicine in the United States, with particular interests in how race, genderand politics shape the medical field and access to health care. Professor Antonovich also founded Nursing Clio, a public-facing academic blog that explores intersections of medicines history (and present) and identity, especially race and gender.

Between 1900 and 1930, efforts to curb abortion, restrict contraceptionand promote eugenics dominated public and legal discourse on marriage, pregnancyand childbirth in the United States. This talk examines the role of women physicians in driving discourse, circulating ideasand setting policy agendas on reproductive surveillance and restrictions during this period. Through two case studies, we will explore how women physicians became an effective force for bringing eugenics to the massesbecoming the middleman between scientist and mother, researcher and reformer.

Antonovichs lecture is in conjunction with the Kahn Institute yearlong project Health and Medicine, Culture and Society: Crossroads in a Liberal Arts Education.

Go here to see the original:

A Desire to Cure, Not to Punish: Women Physicians and Eugenics in the American West, 19001930 by Jacqueline D. Antonovich - Smith College Grcourt Gate

Silence will not protect our democracy – The Oxford Eagle – Oxford Eagle

Posted on by

Published 8:00 am Sunday, October 16, 2022

By Jeff Justice

January 1933, the month and year of my birth, witnessed the inauguration of Franklin Delano Roosevelt, a man of privilege who brought us out of a depression through social programs and an understanding of the needs of the American people. At the same time, in Europe, Adolf Hitler was appointed Chancellor of Germany. There were many good people who remained silent during his rise to power as their neighbors were taken in by Hitlers rhetoric and lies. Responding to a fire of questionable origin in the Reichstag, within four weeks he had instituted the Reich Fire Policies and later an Enabling Act, assuring that he would have the power to make and enforce laws without the involvement of the Reichstag, thus bypassing the system of checks and balances. This ultimately led to the loss of individual rights and since the German people were constantly bombarded with lies about the Jewish people, the superiority of Aryans and because too many remained silent, there was tacit acceptance of immoral policies: Kristallnacht, Eugenics and the Holocaust.

There are disturbing parallels in our current political environment. I think the persistent racial and religious rumors surrounding our first black president and echoed by Donald Trump (Obama is a Muslim and was born in Africa) have been accepted by a surprisingly large number of Americans whose judgment has been clouded and confused by politicians more interested in their personal agendas than in the well-being of our democracy.

Why have so many Americans accepted Trumps lie that his election was stolen despite physical evidence that proves otherwise? Through his rhetoric and actions, he has condoned and encouraged, violence to the end of saving the country from an illegal presidency and from an invasion of aliens and the scourge of replacement of the white race.

Just as German citizens remained silent in the 1930s, many Americans, nearly 100 years later, remain silent when neighbors, friends, and family seem to accept lies concerning the 2020 election and the insurrection of January 6. Unfortunately, silence will not protect our constitutional democracy and should no longer be an option in our Reichstag moment. There should be no shame assigned to the many people who voted for Trump in the 2016 or 2020 election and, as with Bush v Gore, no one should be blamed for demanding a recount, but once that had been accomplished and the result was in, the candidate and his supporters should have accepted the result and participated in the constitutionally mandated peaceful transfer of power. Otherwise, our democracy will be lost.

Jeff Justice

Oxford

Read the rest here:

Silence will not protect our democracy - The Oxford Eagle - Oxford Eagle

Hope Dies Last: A tte–tte with Alan Weisman – The Business Standard

Posted on by

"The imaginative power of 'The World Without Us' is compulsive and nearly hypnotic - make sure you have time to be kidnapped into Alan Weisman's alternative world before you sit down with the book because you will not soon return. This is a text that has a chance to change people, and so make a real difference for the planet," wrote award-winning author Charles Wohlforth in a review of the New York Times bestseller 'The World Without Us' by Alan Weisman.

Alan Weisman, the journalist, author of six books, and a professor of journalism, recently visited Bangladesh.

Although not 'kidnapped,' we were indeed captivated by the writer's lifetime of experience and wisdom when Weisman sat down in an interview with The Business Standard.

We managed 'to return' to produce an abridged version of the interview with Weisman.

What brought you to Bangladesh?

I am working on a book with kind of a vast topic, which is what are humanity's best and most realistic hopes for getting through this very difficult century that we have.

I am looking at energy issues, food production, and how to preserve nature in the teeth of a major extinction event.

I am particularly looking at individuals who, despite the long odds and despite what they know about the change in climate, or other problems - problems with their governments or political problems - are still determined to find us a way to the future.

I have been doing this in several different countries. I started my research in Colombia and I was in Honduras, in Mexico along the Mesoamerican reef which is the longest coral reef in the world outside of the Great Barrier Reef in Australia.

I was looking at the reef system; I was with scientists and local coastal managers looking at how to protect the coast from climate change by using reefs and dunes and mangroves - things like that.

I have also been to Spain, I have been to the Netherlands. I went to the latter because New York City was talking to Dutch consultants on how to protect the city from rising sea levels using barriers. The same thing is happening in Miami, in New Orleans, in Jakarta and Manila, [and] places all over the world including Bangladesh.

And that was interesting to me because like Bangladesh, the Netherlands is kind of the drain of Europe- the two major rivers the Meuse and the Rhine enter the sea there. The Netherlands, for 800 years, have devised water policies to keep from drowning but how would that translate to a country four times bigger with much more powerful rivers - the Brahmaputra and the Padma and the Meghna? Could Bangladesh afford it? How would it work?

But other things had also occurred to me about Bangladesh that were very important for my book. One was biodiversity in the Sundarbans -the most important mangrove forest in the world and one of the most important tiger reserves in the world.

I had also done some research for my book on jaguars in the Americas so looking at tigers was like a very nice compliment. And then the decision to build a coal-fired plant in Rampal, right at the edge of the Sundarbans!

So those were the three reasons that I wanted to come to Bangladesh: the Bangladesh Delta Plan 2100, the Sundarbans, and to see why coal is still being burnt here while the rest of the world is turning away from it or at least was before Russia invaded Ukraine.

Is this new book a sequel to your last book, 'Countdown: Our last, best hope for a future on earth?'

Some people have said that. 'Countdown' was about how our species would suddenly quadruple in a single century, which never happened before for any large species, and what position that would leave us in.

Many people have asked me if I think that overpopulation is the biggest environmental problem and my reply is, well, if there were not so many people would we even have environmental problems?

Then in my previous book 'The world without us', which was kind of a backward way of looking at the environment, I tricked people into reading an environmental book because people are always scared that oh these books are so grim and scary and they say well we are all gonna die anyway, so I just killed everybody right off in the beginning and they (readers) did not have to worry about that anymore and everybody loves to look at the future, so that is what the book was about- a future without us.

My hope was, and I think it worked, that people were just fascinated by how quickly nature would recover things and how quickly it would break down our infrastructure.

What I really hoped was that readers would say oh, that is such a beautiful world now! Is there some way we could still have that world and also keep human beings as part of it so we could live in harmony with nature instead of in what I call Mortal Kombat with nature?

Someone I had an interview with thought that we should just stop having babies and let the human race die off in 100 years because now we are making such a mess of things that if we just let ourselves gradually vanish over a century then at least we would not be bringing all these other species down with us.

So, knowing that I wrote the book because I do want a world with us and not without us, I had to find out how many babies we are producing now; and then I found out that the numbers are astonishing - we add about one million people every four days and that is clearly not sustainable.

But that caused me to write 'Countdown'. And so many people have said that the current book I am working on - which is going to be called 'Hope dies last' - is kind of the last one of a trilogy.

When anyone talks about family planning in the context of population control, the first thing that may come to their mind is eugenics. This kind of discourses have been used to oppress working class and low caste women all around the world. So is there a way to do population control without it being used to justify eugenics and oppression of women?

First of all, the phrase population control has turned out to be a very uncomfortable phrase because this sounds like controlling women and women do not want it. The very first big applied eugenics was not an experiment, it was a programme done by the United States on the island of Puerto Rico.

It was in the 1930s when the population was starting to explode. The United States has shamefully treated Puerto Rico like a colony. There, women would go into the clinic sometimes because they were sick, they had the flu, [and] they would come out with a tubal ligation. They had no idea this was gonna happen. It was a shameful process.

The next big one was in India during the 1970s.About seven to eight million women were forcibly sterilised there. About the same number of men were also forcibly vasectomised.

It was terrible and it happened at the same time that the feminist movement was growing in the world so anything having to do with population control became a way of men controlling women's bodies and they were violently opposed to it.

Then in 1980, China's one child policy came in and there was more forced sterilisation and forced abortion there. And I wrote about this in 'Countdown' and it was a very surprising chapter to particularly readers in my country: the solution, to answer to your question, came from a Muslim country.

During the Iraq-Iran war, NATO was supplying armaments and even the raw materials for nerve gas to the Iraqis. All Iran had were (dead) bodies, so Ayatollah Khomeini issued a fatwa asking every fertile woman in Iran to do her patriotic duty and get pregnant to produce a 20 million person army to fight the invaders. And so the fertility rate in Iran was at one point probably the highest in human history.

But at the end of the war, the economist who was the head of the budget went to the Ayatollah and said all these children who were born during the war, they are gonna grow up in the next 10 to 15 years and they were not going to be able to employ all of them.

(The new) Ayatollah issued a fatwa saying there is nothing in the Quran that prohibits having a tubal ligation or a vasectomy if you have the number of children you believe you can responsibly care for.

They left the decision to everybody but the only thing that was obligatory was premarital classes where if you are getting married, you have to go to either the mosque or a clinic and learn, among other things, how much it costs to raise, feed, and clothe a child.

A lot of people got the message that way. They also made contraception - everything from condoms to operations - free and accessible throughout the country. And they did not call it population control, they called it family planning.

Leaving the decision to women is empowering, that is not eugenics. Giving women reproductive rights, that is the way to go.

Is the solution you envision for climate change compatible with capitalism, that is, with the relentless pursuit for profit that animates multinational corporations and monopolies?

Two things got us into the trouble that we are at. One is overpopulation, which happened for two main reasons: 1. modern medicine reduced infant mortality and 2. the average lifespan of human beings is almost double of what it was before the smallpox vaccine started all these medical improvements.

But much more important than that was we learned how to produce much more food than nature ever could by force feeding cultivation with chemical and nitrate synthetic nitrogen fertiliser.

This fertiliser also produces a lot of problems: greenhouse gases when it is made because it is very energy intensive, and then when it breaks down it produces nitrous oxide, which, after methane, is the third most powerful greenhouse gas.

Secondly, big population has been a boon to capitalism because it meant more consumers, and companies got richer. The other reason that capitalism thrives on big populations is that the more people there are the cheaper labour is.

This is why we hear economists say that it is dangerous to have family planning programmes. One of the excesses of capitalism is now the very top one-tenth of 1% has most of the money in the world and that is wrong.

Businesses got us into this trouble, partly, along with the population, and now we need businesses' help to get us out of this trouble. It is really important that businesses become convinced that they can make money doing things to help the climate.

Reading your book, 'Countdown' feels like having a world tour. You surely travelled dozens of countries before writing that one. How long does it take for you to write a book?

Yes, I visited 21 countries. I started the research for 'Countdown' in 2009 and the book came out in 2013. I was so exhausted after that. This one was supposed to come out in 2022, but because of the pandemic it will come out in 2024. I am probably seeing nine countries and several places in the US for this book. I wish I could see the whole world.

I started working intensely on 'The World Without Us' at the end of 2004, and it came out in 2007. I brought into it some reporting I had done before. So, sometimes I think that the research for these books has taken all my career because everything that I have learned I bring into them.

What have you seen in Bangladesh apart from the Sundarbans?

I went to Kutubdia Island, which was damaged terribly during the 1991 cyclone. Then I went to a climate refugee camp on the mainland where thousands of people were taken. It is arguably the first climate refugee camp on earth and it is here in Bangladesh.

I went to one of the Rohingya refugee camps. There I spoke to a solar energy company, which is an interest of mine coupled with the coal fired power plants.

Bangladesh at one point was the fastest growing solar development in the world, but things have shifted. There are solar panels everywhere, you see them in Dhaka but they are not connected to the grid in most cases. They are there because there is some building code that requires solar panels (on the roof).

My country does really stupid things all the time so I am not singling Bangladesh out as being stupid.You have got the infrastructure in place; please connect up those panels to the grid right now. It will ease a lot of this load sharing, if not all of it, and the smell and noise from diesel will cease.

You surely have been reading Bangladeshi newspapers. As a journalist, do you have any observations on the country's media industry?

Yes, I have been reading the English language newspapers. I think you guys have been very careful to report well without *[upsetting] the government. Every country that self-sensors, for instance the Israelis, are famous for this: they find ways to insert the truth.

When you are reading, it has got double meaning: you know you are reading this but an astute reader will really know that oh, so this is what is going on.

I am sorry that you have to be careful with your government. But now that journalism is under stress, we need journalists more than ever.

So what is our 'last best hope for a future on earth'?

As I said, the future is uncertain. The climate- it is already warmer, there is already more carbon dioxide than there has been in the atmosphere since over three million years ago.

But there are great minds everywhere in the world. Use those minds and if we do our best and our smartest then maybe humanity can find a way to coexist with the warmer world that we are certain to have.

The most important thing we can do now is to stop accelerating that warming. Turn this around before this really gets out of control.

View original post here:

Hope Dies Last: A tte--tte with Alan Weisman - The Business Standard

20 million black babies have been aborted since Roe v. Wade. Where is the equity in that? – Washington Examiner

Posted on by

Democrats love to talk about abortion and systemic racism, just not in the same conversation.

The National Right to Life Center estimates that by the end of 2021, 63.5 million abortions had been performed in the United States since the Supreme Courts 1973 Roe v. Wade decision. Nearly 40% of women who seek abortions are African American, which is astounding, considering this demographic made up just 13.6% of the population at the time of the 2020 census. This likely means that over 20 million black babies have been aborted during the past 50 years.

20 million equates to 6% of the total U.S. population. Its also approximately 45% of the current black American population of 45 million. And, had these children been born, blacks would represent about 20% of the total population. Clearly, abortion has had an enormous effect on blacks in America.

THE FIVE STATES THAT WILL HAVE ABORTION MEASURES ON THE BALLOT IN NOVEMBER

In August 2019, then-New York Times Executive Editor Dean Baquet assembled his troops to introduce the controversial 1619 Project, their deliberate attempt to "reframe Americas history, understanding 1619 as our true founding, and placing the consequences of slavery and the contributions of black Americans at the very center of the story we tell ourselves about who we are."

The editors of the "paper of record" had decided that systemic racism should become the central issue in the upcoming presidential campaign. Baquet told his staff, "Race in the next year and I think, to be frank, what I hope you come away from this discussion with race in the next year is going to be a huge part of the American story."

Following George Floyds death in May 2020, systemic racism exploded into the national debate. Suddenly, every institution, the U.S. justice system, our history, our Founding Fathers, and of course, every Republican, was declared racist. Woke corporations forced employees to attend diversity training sessions to learn how to be "less white." And demands for equity became ubiquitous.

Planned Parenthood was also forced to recognize its own racist roots. The group admitted that Margaret Sanger, the organizations founder, was a racist with "harmful connections to the eugenics movement." Sanger established a predecessor organization, "The Negro Project," in 1939. In turn, Planned Parenthood removed Sangers name from its Manhattan health clinic and renamed nearby "Margaret Sanger Square." In a later, more formal declaration that it called "a reckoning," Planned Parenthood acknowledged that Sanger was a white supremacist. The group also confirmed that Sanger delivered a speech to "a womens auxiliary branch of the Ku Klux Klan in Silver Lake, New Jersey, in 1926."

The statement said Sanger "believed in eugenics an inherently racist and ableist ideology that labeled certain people unfit to have children." It added that Sangers actions had "undermined reproductive freedom and caused irreparable damage to the health and lives of generations of Black people, Latino people, Indigenous people, immigrants, people with disabilities, people with low incomes, and many others."

The racial disparities between abortion rates for black and white women in America cannot be denied. In his concurrence in the 2019 abortion case Box v. Planned Parenthood of Indiana and Kentucky, Justice Clarence Thomas wrote: "There are areas of New York City in which black children are more likely to be aborted than they are to be born alive and are up to eight times more likely to be aborted than white children in the same area." Unfortunately, renaming a clinic in New York City and disavowing the organizations founder are woefully insufficient to compensate for the evils put in motion by this repellent woman and perpetuated by her successors.

So, yes, lets talk about abortion and systemic racism in the same conversation.

CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER

Elizabeth Stauffer is a contributor tothe Washington Examiner andthe Western Journal.Her articles have appeared atMSN,RedState,Newsmax, theFederalist, andRealClearPolitics. Follow her onTwitterorLinkedIn.

See the original post here:

20 million black babies have been aborted since Roe v. Wade. Where is the equity in that? - Washington Examiner

An overdue renaming of the Vassal Lane school wins approval, with process to end by summer – Cambridge Day

Posted on by

The Vassal Lane Upper School, temporarily in East Cambridge, should have a new name by the time it reopens in West Cambridge. (Photo: Marc Levy)

A second Cambridge public school is on track for a name change to avoid honoring a racist.

The School Committee agreed unanimously Tuesday to find a new name for the Vassal Lane Upper School before the end of this academic year, asking the district to propose how by Dec. 31.

The citys four upper schools are all identified by the names of their street addresses, but that means the Vassal Lane Upper School by extension honors John Vassal, whose family enslaved hundreds in the Jamaican sugar industry. The family were Loyalists during the American Revolution who fled Cambridge for Boston in 1774, then moved to Canada.

Theres an early front-runner for replacing the name of John Vassal, and one in which some committee members found some satisfaction: Darby Vassal.

Darby Vassal was once enslaved by John Vassal but by the time of his death in 1782, had become an activist with religious, political and economic societies of the time, according to the History Cambridge organization. An art installation up through Nov. 6 at Christ Church, Cambridge, in Harvard Square, tells his story and reveals his tomb under the church, with the Vassal family.

We very easily could name the school tonight. We have lots of ideas of who we want to honor, said vice chair Rachel Weinstein, who wrote the motion for the renaming. But we want this to be an inclusive process.

Precedent from 2002

This will not be the first time a Cambridge school is renamed to avoid the stain of racism. The Maria L. Baldwin School was known as the Agassiz School from 1874 until 2002, but that name was associated with Louis Agassiz, a Harvard scholar who promoted eugenics. (The school is in the Baldwin neighborhood, which was renamed from the Agassiz neighborhood in August 2021.)

The call to change the name of the Vassal Lane Upper School came from students and it was students who led the work for the Baldwin name changes, noted Carolyn Turk, the districts deputy superintendent. In each process, there were students who did a tremendous amount of research, yet in each case they knew this was something the community needed to be a part of, Turk said.

Still, superintendent Victoria Greer said those who attend the school or did attend it which includes children of Weinstein and fellow committee member David Weinstein (no relation) should have a strong voice in deciding the change. Greer said her process would turn first to Vassall students, staff and faculty; principal Daniel Coplon-Newfield has begun work, she said.

Black, indigenous and other

Rachel Weinsteins motion asks that the name change honors a Black Cantabrigian or multiple local Black leaders who contributed to the advancement of equitable education, civil rights and the community, leading member JosLuis Rojas Villarreal to ask if the order couldnt be broadened to include consideration of indigenous peoples such as those of local interest highlighted by the work of History Cambridge.

There was resistance from Weinstein and others. For this particular school, it seems most appropriate to face the history of enslavement right here in Cambridge and speak to it and do some healing. It would feel like a slight not not to acknowledge the black history tied to the Vassal name, she said. You make a good point about in general about recognizing the diversity of our student population and ensuring that all students see themselves reflected we have three other upper schools that are also named after the streets theyre located on.

There should at least be a stated intent to consider indigenous peoples and other minorities in the renamings, Rojas said drawing a suggestion from Mayor Sumbul Siddiqui to submit a motion calling for that instead of amending the Tuesday order.

Siddiqui agreed it made sense to overwrite the Vassal Lane name with a name that honored black residents, and student committee member Adelina Escamilla-Salomon agreed there was extreme value in renaming the school to honor a black person where young people would be going and learning its history. I do see the value in what member Rojas was saying.

A change for the street named after John Vassal is likely to be proposed as well. A City Council policy order adopted in June 2019 called for review of monuments, memorials and markers throughout the city to see which honored people linked to the slave trade or engaged in other similarly shameful acts and due for a rethinking.

There are a lot of things that need be renamed, Siddiqui said, promising recommendations in the next one to three years.

Long overdue

The Vassal Lane Upper Schools in fact, all of the upper schools are long overdue for it. They were created as part of an Innovation Agenda approved by the committee in March 2011, and then-superintendent Jeff Young told city councillors at a June 2012 budget hearing that the renaming process for each would begin that fall, possibly through contests.

The street names were meant to be placeholders, Young said. We looked at it as the one element of the Innovation Agenda that would not be controversial.

Two of the four schools have even been through elaborate and expensive campus reconstructions without getting new names. Vassal Lanes campus in West Cambridge, shared with the Tobin Montessori School, is undergoing a $299 million renovation now, during which the upper school has relocated to 158 Spring St., East Cambridge. The schools expected reopening is in the fall of 2025.

More here:

An overdue renaming of the Vassal Lane school wins approval, with process to end by summer - Cambridge Day

Charles River and Nanoscope Therapeutics Announce Multifaceted Gene Therapy Manufacturing Partnership – PR Newswire

Posted on by

Charles River will manufacture both plasmid DNA and viral vectors for late phase clinical trials targeting degenerative ocular diseases with no known cure

WILMINGTON, Mass. and DALLAS, Oct. 18, 2022 /PRNewswire/ -- Charles River Laboratories International, Inc. and Nanoscope Therapeutics, Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced a comprehensive manufacturing collaboration utilizing Charles River's extensive contract development and manufacturing (CDMO) services in both plasmid DNA and viral vectors.

"We are excited to continue to support Nanoscope Therapeutics' efforts in the production of gene therapies that are focused on restoring vision for people suffering from retinal degenerative diseases with no known cure. Their work is incredibly important to patients, and we look forward to continuing to serve as a partner," said Kerstin Dolph, Corporate Senior Vice President of Biologics Solutions at Charles River.

"Nanoscope looks forward to working with Charles River to support our accelerated development program. We have high expectations for our program and are counting on Charles River leadership, resources and scale to deliver in this partnership," said Anil Lalwani, Vice President of CMC at Nanoscope Therapeutics, Inc.

A Robust Manufacturing Collaboration

Through this partnership, Nanoscope will have access to established manufacturing platforms and multiple Charles River CDMO centers of excellence, leveraging a comprehensive range of services including but not limited to GMP cell banking, High Quality (HQ) and GMP-grade plasmid DNA manufacture, and GMP adeno-associated virus (AAV) production.

This gene therapy manufacturing partnership builds on Charles River's acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021 that expanded its comprehensive cell and gene therapy (C>) portfolio to span each of the major CDMO platforms cell therapy, viral vector, and plasmid DNA production.

Treating Degenerative Retinal Diseases

Nanoscope Therapeutics is developing gene-agnostic, sight restoring Multi-Characteristic Opsin (MCO) optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. Nanoscope's optogenetic therapy uses a proprietary AAV2 vector to deliver MCO genes into retinal cells to enable vision in different color environments. The therapy is administered as a single intravitreal injection for in-office delivery without the need for any other devices or interventions.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visitwww.criver.com.

About Nanoscope Therapeutics Inc.

Nanoscope Therapeutics is developing gene-agnostic, sight restoring optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. The company's lead asset, MCO-010, is presently in Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trials in the U.S. for retinitis pigmentosa (NCT04945772) with top line data expected H1 2023. The company has also fully enrolled a Phase 2 trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA Fast Track designation for RP and FDA orphan drug designations for RP and Stargardt. Preclinical assets include non-viral laser delivered MCO-020 gene therapy for geographic atrophy.

Nanoscope Investor Contact:Argot Partners212-600-1902[emailprotected]

Charles River Investor Contact:Todd SpencerCorporate Vice President,Investor Relations781.222.6455[emailprotected]

Charles River Media Contact:Amy CianciarusoCorporate Vice President,Chief Communications Officer781.222.6168[emailprotected]

SOURCE Nanoscope Therapeutics

See the original post here:

Charles River and Nanoscope Therapeutics Announce Multifaceted Gene Therapy Manufacturing Partnership - PR Newswire

Gene therapy can make a real impact on global health but we need equitable access, say experts – World Economic Forum

Posted on by

Low- and middle-income countries (LMICs) can and should play a leading role in dictating the future of the worlds most advanced healthcare technologies, according to the World Economic Forums Accelerating Global Access to Gene Therapies: Case Studies from Low- and Middle-Income Countries white paper.

Gene therapy is at the forefront of modern medicine. By making precise changes to the human genome, these sophisticated technologies can potentially lead to one-time lifelong cures for infectious and non-communicable diseases (e.g. HIV, sickle cell disease) that affect tens of millions of people around the globe, most of whom live in LMICs. However, too often the benefits of advanced healthcare technologies remain restricted to high-income countries (HICs), a reality that could happen to gene therapies.

The narrative that new healthcare technologies are unsuitable for LMICs is a long-standing rationale for excluding a majority of the world from the benefits of modern medicine. Without concerted efforts to build gene therapy capacity in LMICs, the global health divide will continue to widen.

The gene therapy industry is in its infancy, but early clinical successes and substantial funding have generated enormous momentum. This is an ideal moment for LMICs to enter the global market, prioritizing the needs of communities carrying the highest disease burdens.

We asked five clinical researchers from LMICs, who are all co-authors on the recent white paper, what innovations on the ground and changes at policy-level need to happen for gene therapy to make a real impact on global health.

Dr. Cissy Kityo Mutuluza, Executive Director, Joint Clinical Research Centre, Uganda

Although gene therapy has the potential to treat or even cure life-limiting diseases and infections, the full impact will only be realized if we deliver it for the benefit of all people, instead of fueling more health inequity between and within countries.

An essential first step towards maximizing the global impact of gene therapies is to build research and development (R&D) capacity in LMICs. Current gene therapy R&D has mainly excluded LMICs, instead centering pre-clinical and clinical work in HICs. Gene therapy R&D needs to be performed in regions where target diseases are prevalent to ensure that these therapies are safe and effective for those populations. Manufacturing technologies and healthcare infrastructure, which are the cost drivers for gene therapy products in HICs, need to be replaced with innovative and simplified platforms and workflows that bring down costs and are functional and cost-effective within LMIC health systems.

As for policy and regulation, individual countries must establish gene therapy frameworks that enable R&D. The construction of such frameworks should be guided by recommendations from the World Health Organization, emphasizing safety, effectiveness and ethics.

A critical component in effective global health interventions is community outreach. Treatment acceptability is essential for future clinical trials, thus it is important for scientists and clinicians to be clear about the risks and benefits of gene therapies. Communication and education activities should be made accessible to a broad range of stakeholders. Gene therapy and gene editing technologies are complex and it can be difficult for the public to understand their possible benefits or side effects. However, patient and public support is critical for the successful adoption of any new technology.

Professor Johnny Mahlangu, University of the Witwatersrand, South Africa

The ongoing COVID-19 pandemic is accelerating innovation, implementation and acceptance of molecular therapeutics (e.g. mRNA vaccines) globally. As a result, there is escalating interest in developing molecular interventions for many other conditions, such as gene therapies for genetic diseases. Strategically leveraging infrastructure that is being developed for molecular therapeutics will be critical in manufacturing, testing, and delivering gene therapies across diverse settings. Three critical areas of consideration include:

The application of precision medicine to save and improve lives relies on good-quality, easily-accessible data on everything from our DNA to lifestyle and environmental factors. The opposite to a one-size-fits-all healthcare system, it has vast, untapped potential to transform the treatment and prediction of rare diseasesand disease in general.

But there is no global governance framework for such data and no common data portal. This is a problem that contributes to the premature deaths of hundreds of millions of rare-disease patients worldwide.

The World Economic Forums Breaking Barriers to Health Data Governance initiative is focused on creating, testing and growing a framework to support effective and responsible access across borders to sensitive health data for the treatment and diagnosis of rare diseases.

The data will be shared via a federated data system: a decentralized approach that allows different institutions to access each others data without that data ever leaving the organization it originated from. This is done via an application programming interface and strikes a balance between simply pooling data (posing security concerns) and limiting access completely.

The project is a collaboration between entities in the UK (Genomics England), Australia (Australian Genomics Health Alliance), Canada (Genomics4RD), and the US (Intermountain Healthcare).

Professor Vikram Mathews, Christian Medical College, Vellore, India

Gene therapy is on course to revolutionize medical care for several conditions. The hope is that gene therapy will be a one-time curative therapeutic intervention for diseases ranging from inherited hemoglobinopathies, such as sickle cell disease and thalassemia, to acquired diseases such as HIV.

A primary challenge limiting access to these life-saving therapies is their astronomical costs, making them inaccessible even in developed countries where most gene therapies have originated. Due to economic challenges, there is often a mismatch between regions in the world where development and clinical research happens versus regions in the world where the incidence of the disease target is the highest. Classic examples of these are sickle cell disease and HIV with the highest incidence rates in Africa.

Moving the manufacturing of gene therapy products to local regions and point of care settings (within hospitals) are strategies that can both significantly reduce the cost of these products and improve accessibility. Additionally, current gene therapy approaches use expensive ex vivo procedures that require removal of a patients cells from their body. Instead, researchers must develop novel in vivo methods that simplify the procedure to a single injection directly into the patient, saving time and money.

Professor Julie Makani, Muhimbili University of Health and Allied Sciences, Tanzania

In order for gene therapy to have an impact on global health, changes in innovation and policy must occur at several levels: individual, institutional, national, continental and global.

At the individual level, patients and personnel are the primary focal points. Taking a patient-centered approach will ensure that the community is involved in research and will have a say in receiving a particular health intervention when it is available. For personnel working in areas pertinent to gene therapy including healthcare, research and education, there is a need to increase knowledge and to change perspectives regarding the advancements and achievements made within the field of gene therapy.

At the national, continental and global levels, genomic research is catalyzed by strategic partnerships and often occur in Centers of Excellence (CoE). Many countries in Africa have established CoEs in academic settings, which integrate health and science programmes. These innovative environments help maximize resources (physical and human) and provide settings that facilitate research and translation of research findings to health interventions to be done contemporaneously, in the appropriate population and geographical region.

At the policy-level, investments in global health and research in gene therapy must change. This can be done in three ways: direct investment to institutions in Africa; increase in the level of investment through funding partnerships; and recognition that the duration of investment needs to be longer than the normal funding cycles of three to five years.

Professor Suradej Hongeng, Mahidol University, Thailand

Gene therapy has received global attention over the last few years, recognition that continues to grow with each new clinical success. The field is constantly evolving, with disruptive innovation across public and private sectors. However, access to these life-saving treatments remain restricted due to a number of technical and policy challenges.

First, researchers must continue to develop cost-effective ways to administer gene therapies into patients, an area of R&D where the private sector can play an important role. Yet many LMICs have weak ecosystems to support the emergence of new companies or entice collaborations with multinational companies. Stronger private sector involvement will be critical for penetration into emerging markets.

Second, the unique nature of these personalized treatments makes them difficult to regulate within traditional frameworks, meaning that agencies must update current policies and regulations. As regulation evolves, it must also converge with the frameworks of other countries. This will make it easier for companies to navigate regulations and interact with agencies when performing clinical trials or bringing a therapy to multiple markets.

Link:

Gene therapy can make a real impact on global health but we need equitable access, say experts - World Economic Forum

Carmine Gets Series A Funding to Develop Non-viral Gene Therapy |… – Cystic Fibrosis News Today

Posted on by

Carmine Therapeutics has completed series A financing to support the development of its innovative, non-viral gene therapy for cystic fibrosis (CF) and other diseases.

The company is working to advance a novel type of disease-modifying gene therapy, which is accomplished using its proprietary Red Cell EV Gene Therapy or REGENT platform. This technology allows the delivery of therapeutic payloads of pieces of genetic information both DNA and RNA to several tissues, including in the central nervous system (involving the brain and spinal cord).

It also enables the transport of shorter and larger segments of genetic information, as well as multiple payloads simultaneously, without inducing an immune or inflammatory response that often render gene therapies less effective, according to Carmine.

REGENTs ability to deliver very large genetic medicines to a broad variety of tissues, without triggering an immune response or excessive inflammation has the potential to extend the promise of gene therapy to numerous human diseases that have been inaccessible to viral based approaches, Don Haut, PhD, Carmines CEO, said in a press release.

CF is causedby mutations in the geneCFTR, which result in an abnormally thick mucus in the bodys organs, particularly in the lungs, pancreas, liver, and intestine.

Gene therapy involves correcting a genetic defect by introducing a normal copy of the affected gene into the patients cells or by silencing a faulty gene. Current gene therapies commonly involve the use of adeno-associated viruses, which are modified in the lab not to cause disease, as delivery vehicles. However, existing approaches pose manufacturing challenges, limit the size of the therapeutic gene, and may induce an immune response.

The REGENT platform uses red-blood-cell-derived extracellular vesicles (RBCEVs), tiny sacs surrounded by a fat layer that can be used to carry genetic material. Since red blood cells naturally lack genetic material, RBCEVs do not represent a risk of triggering an immune response and therefore enable re-dosing, according to Carmine.

Also, large amounts of RBCEVs can be obtained from a single unit of blood and are highly amenable for manipulation. The REGENT platform was based on research led by the companys co-foundersMinh Le, PhD, and Jiahai Shi, PhD, at theNational University of Singapore, andHarvey Lodish, PhD, at the Massachusetts Institute of Technology.

The Cystic Fibrosis Foundation and Huagai Capital are two new investors in this financing round. They join existing investors EVX Ventures and Simcere Pharmaceutical.

We are delighted to bring a terrific group of new investors who share our vision of the next generation of gene therapies into Carmine, said Haut.

The funding will first be used to advance the clinical development of the gene therapy for retinal (eye) and pulmonary diseases.

We are thrilled to join [the] Carmine family, said Deng Liang, of Huagai Capital. As an early-stage investor in biotech industry, we value Carmines RBCEV platform as a novel and advantageous delivery system in gene therapies, especially considering its payload capacity, costs, and safety. Combined with Carmines patented payload engineering methods, we believe Carmine would bring patients with promising curative therapies.

Added XQ Lin, Carmines chairman and founder: We are pleased to welcome Huagai Capital and the Cystic Fibrosis Foundation as new investors into Carmine and thank our existing shareholders for their continued support.

Non-viral gene therapy is a promising new modality with the potential to address many unmet medical needs, he said.

See the article here:

Carmine Gets Series A Funding to Develop Non-viral Gene Therapy |... - Cystic Fibrosis News Today

Gene Therapy Has Arrived. But So Will the $$$$$ Bills. | AMCP Nexus 2022 – Managed Healthcare Executive

Posted on by

Evernorth's Aimee Tharaldson discussed the growing number of gene therapies in her keynote talk today on specialty drug at AMCP Nexus 2022. She listed 12 approved gene therapies, eight in the near-term pipeline for hemophilia and another seven for other diseases that may be approved next year.

Gene therapy, once the stuff of scientific aspiration, is fast becoming a clinical reality in U.S. healthcare but with staggering tags. In her keynote talk today on specialty drugs at AMCP Nexus 2022, Aimee Tharaldson, Pharm.D., listed 12 approved gene therapies and another seven that could be approved next year.

Tharaldson, senior clinical pharmacist, emerging therapeutics, at Evernorth, told the large audience for her morning talk that 500 gene therapies are in clinical trials and that as many 1 million American will be treated with a gene therapy by 2034.

But Tharaldson also noted the cost, with the one-time gene replacement therapies priced at more in the millions of dollars. Citing a paper from the National Bureau of Economic Research, Tharaldson said the cumulative annual cost of gene therapies could reach $25 billion by 2034.

It is going to be interesting to see what happens because they are very expensive, Tharaldson said in a brief interview after her talk, which drew a large audience on the third day of the AMCP Nexus meeting in National Harbor, Maryland. Some of them are coming to market with pretty good data and some will likely come to market with not the best data. They are just going to need to be evaluated carefully to make sure they are effective and safe and have a durable effect.

Some of the gene therapies have been promoted as curative but Tharaldson sounded a note of caution :I dont think we have enough information at this point to say there are curative.

Tharaldson listed 12 approved gene therapies in her talk and another seven that could be approved by the FDA in 2023, including a gene therapy for Duchenne muscular dystrophy that could be priced at $3 million.

Three of the gene therapies that might be approved next year are for dystrophic epidermolysis bullosa, a rare skin disease.

Tharaldson also listed eight hemophilia gene therapies that are in late-stage development and could be approved over the next several years. One, etranacogene dezaparvovec, may be approved next month.

Value-based contracts have been discussed as one way to possibly hedge some of the cost impacts of the gene therapies. Tharaldson mentioned that Bluebird Bio has proposed a value-based contract for Zynteglo (betibeglogene autotemcel), its gene therapy for beta thalassemia, a blood disorder that results in hemoglobin levels. Bluebird priced the one-time gene replacement therapy, which was approved by the FDA in August 2022, at $2.8 million, but the company has also said that it would reimburse payers for perhaps as much 80% of that cost if patients do not stay "transfusion independent" for two years.

The FDA approved another Bluebird gene replacement therapy, Skysona (elivaldogene autotemcel), a treatment for cerebral adrenoleukodystrophy, a rare neurological condition, in September 2022. The price of $3 million is similar to price Zynteglo but Tharaldson said Bluebird hasn't offered any value-based terms for Skysona.

Here are some of the other highlights from Tharaldsons information-dense talk

Read more:

Gene Therapy Has Arrived. But So Will the $$$$$ Bills. | AMCP Nexus 2022 - Managed Healthcare Executive

FDA Expands Oversight of Cell and Gene Therapies – Pharmaceutical Technology Magazine

Posted on by

CBER maps modernization plan to handle surge in research and applications.

FDAs Center for Biologics Evaluation and Research (CBER) is updating how it manages a growing volume of cellular and gene therapy development programs, seeking added resources and revisions in its oversight of these cutting-edge therapies. Most visible in the elevation of CBERs Office of Tissues and Advanced Therapies (OTAT) into a new super Office of Therapeutic Products (OTP). The change aims to improve functional alignment, increase review capabilities, and add expertise on new cell and gene therapies by establishing multiple branches and divisions in the expanded regulatory unit, as announced in the Federal Register on Sept. 28, 2002.

Stated goals are to help CBER address the substantial growth in innovative, novel products that present new scientific, medical and regulatory challenges that require changes to its structure, including strategies to advance the Regenerative Medicine Advanced Therapy (RMAT) program. The added resources are needed to oversee more than 2000 development programs involving cellular and gene therapies, many involving innovative testing and manufacturing processes. This soaring workload has over-taxed CBER staffers, resulting in serious difficulties in retaining and hiring capable scientists.

The structural changes at CBER reflect agreed-on plans to hire new staffers with funding from recently reauthorized user fee programs. The PDUFA VII commitment letter calls for an additional 132 new hires for CBER in this coming year and another 48 employees the following year, most to support cell and gene therapy reviews at OTP. The reorganization plan calls for OTP to have seven officesfor therapeutic products, clinical evaluation, review management, pharmacology/toxicology, and two for CMCfor gene therapy and for cellular therapy and human tissues. There will be 14 divisions and 32 branches within those offices, providing attractive supervisory opportunities for both new and experienced staffers.

These changes come in the wake of FDA approval of two new gene therapies that have drawn wide attention for both their therapeutic potential and for million-dollar price tags. Bluebird bios Zynteglo was approved by FDA in August for patients with beta thalassemia, an inherited blood disorder causing serious anemia. That was followed a few weeks later with approval of Bluebirds Skysona to treat a rare neurological disorder afflicting young boys. Zynteglo carries a $2.8 million price tag, Skysonas list price is $4 million, but both therapies are expected to target fewer than 1500 patients, limiting the overall cost impact for the US healthcare system. A greater spending effect would come from FDA approval of a new treatment for sickle cell disease from Vertex Pharmaceuticals and CRISPR Therapeutics, which plan to begin a rolling review by FDA in the coming months. The important potential benefits of these treatments, along with concerns about their impact on healthcare spending and access, speaks to the need for a highly capable and sufficiently resourced FDA oversight program.

These developments also highlight the importance of sound testing and production methods for therapies made from living organisms, which are inherently variable and difficult to control and measure to assure product safety, identify, quality, purity, and strength. The surge in applications from a broad range of firms, moreover, has made it difficult for CBER staffers to schedule formal meetings with each sponsor seeking advice on how best to perform manufacturing and testing processes. And publishing new guidance on these changing and emerging issues also takes time and resources.

In response, FDA looks to engage a broad range of sponsors on topics related to product development through a series of virtual town hall meetings. The first was held Sept. 29, 2022 and addressed how manufacturers should describe and inform FDA about chemistry, manufacturing, and controls (CMC) in applications for gene therapies. Wilson Bryan, OTAT (now OTP) director, opened the session by describing plans for establishing OTP as a super office to increase review capabilities and enhance expertise on gene and cellular therapies and set the stage for OTP branch chiefs to field a broad range of queries, ranging from basic CMC policies for various stages of development, to the scope of potency assays and impact of delivery devices on dose potency and quality [a recording of the town hall meeting is available at the FDA events link].

Main topics were comparability testing, assays for product characterization, and process controls. OTP staffers emphasized the importance of determining process requirements early in development to avoid late changes and analytical method variability that could raise uncertainties likely to delay clinical trials. Products with complex mechanisms of action, they advised, stand to benefit from early product characterization and potency assay development. And developers of gene therapies should use multiple production lots during a clinical study to ensure product consistency and quality, even for treatments for very small patient populations.

Manufacturers raised questions about differing CMC issues between early Phase I and late-stage clinical trials and voiced concerns about product characterization related to autologous cell-based gene therapies. A main theme from FDA was the importance of sponsors establishing a well-controlled manufacturing process and qualified analytical testing well before administering any new gene product. While CBER plans to issue guidance on manufacturing changes and comparability for cellular and gene therapy products, the information provided at this session provides unofficial guidance for implementing changes in product manufacturing and the scope of comparability assessments and development studies expected to support such changes.

Jill Wechsler is Washington editor for Pharmaceutical Technology.

Go here to read the rest:

FDA Expands Oversight of Cell and Gene Therapies - Pharmaceutical Technology Magazine

Decibel Therapeutics Receives FDA Clearance of IND Application for DB-OTO, a Gene Therapy Product Candidate Designed to Provide Hearing to Individuals…

Posted on by

The IND for DB-OTO provides clearance for the Company to initiate a pediatric Phase 1/2 clinical trial in the U.S. in children and infants, and is part of an international regulatory strategy for clinical development

One-time administration of DB-OTO has resulted in production of otoferlin protein and durable auditory brainstem responses to sound in a congenitally deaf rodent disease model

DB-OTO is Decibels second hearing therapeutic candidate to enter clinical investigation

BOSTON, Oct. 17, 2022 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate. DB-OTO is designed to provide durable hearing in individuals born with profound congenital hearing loss due to an otoferlin deficiency.

We are thrilled to work with families, advocacy groups and clinicians in the deaf and hard of hearing community to advance DB-OTO into the clinic, said Laurence Reid, Ph.D., Chief Executive Officer at Decibel. Decibel has assembled a compelling preclinical data package showing that DB-OTO demonstrated a favorable tolerability profile and an ability to stably generate full-length otoferlin transcript, express otoferlin protein and provide hearing in animal models. We are at an exciting time in the development of a new wave of precision gene therapies for children who are deaf and hard of hearing.

DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based, dual-vector, gene therapy product candidate. Otoferlin is a protein expressed in cochlear inner hair cells that enables communication between the sensory hair cells of the inner ear and the auditory nerve. Newborns born with mutations in the otoferlin gene have fully developed structures within the inner ear. However, these newborns have profound hearing loss because signaling between the ear and the brain is disrupted. DB-OTO uses a proprietary, cell-selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing. DB-OTO received Orphan Drug and Rare Pediatric Disease designations from the FDA in 2021. Currently, there are no approved pharmacologic treatment options for individuals with otoferlin-related hearing loss.

In preclinical studies, Decibel observed that delivery of DB-OTO to the inner ear resulted in production of otoferlin protein and durable auditory brainstem responses to sound in a congenitally deaf, rodent otoferlin disease model. Preclinical studies in non-human primates demonstrated that the local delivery procedure for DB-OTO, an intra-cochlear injection using the surgical approach employed by neurotologists and pediatric otolaryngologists during a standard cochlear implantation procedure, resulted in successful distribution and expression of otoferlin protein across the cochlear length.

The Phase 1/2 dose escalation clinical trial is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency. In addition to safety and tolerability endpoints, established, clinically relevant, objective and behavioral measurements of hearing will be used as efficacy endpoints in the clinical trial. The auditory brainstem response, which was used to characterize dose-response of DB-OTO after intra-cochlear delivery in translational studies, will serve as an early, objective, clinically accepted readout of hearing thresholds in the clinical trial.

Otolaryngologists, audiologists and auditory scientists have long awaited the clinical realization of the promise of biological therapies for hearing loss. Gene therapy for congenital deafness represents one such intervention and it would be an understatement to say that clinicians in the field of hearing loss are quite excited to see its advancement into clinical trials, said Jay Rubinstein, M.D., Ph.D., Professor and Virginia Merrill Bloedel Chair in Otolaryngology, Head and Neck Surgery at the University of Washington School of Medicine.

Based on discussions with the FDA during the IND review period, Decibel expects the first two participants in the U.S. portion of the Phase 1/2 trial will be as young as seven years of age and that subsequent participants will include children as young as two years of age and infants younger than two years of age. The Company intends to provide an update on the design of the clinical trial in the future. The DB-OTO IND is part of an international regulatory strategy for development of DB-OTO, which also includes plans to submit one or more Clinical Trial Applications (CTAs) in Europe.

DB-OTO is the second product candidate in Decibels pipeline to advance into clinical testing. In June 2022, Decibel reported positive data from the interim analysis of the Companys Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate (STS) designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. In the data from the interim analysis, 88% of patients experienced ototoxicity in their placebo-treated ear, and of these patients, 87% were partially or completely protected from ototoxicity in their DB-020-treated ears.

About Decibel TherapeuticsDecibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibels pipeline, including its lead gene therapy product candidate, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of creating a world of connection for people with hearing and balance disorders. For more information about Decibel Therapeutics, please visit http://www.decibeltx.com or follow us on Twitter.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Decibels strategy, future operations, prospects, plans, objectives of management, the therapeutic potential for Decibels product candidates and preclinical programs, the potential benefits of cell-selective expression, plans to submit one or more CTAs in Europe and the expected timeline for initiating a Phase 1/2 clinical trial of DB-OTO constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words anticipate, believe, continue, could, estimate, expect, intend, may, might, objective, ongoing, plan, predict, project, potential, should, or would, or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Decibel may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the timing of and Decibels ability to obtain approval to initiate clinical development of its program candidates, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, whether Decibels cash resources are sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, uncertainties related to the impact of the COVID-19 pandemic on Decibels business and operations, as well as the risks and uncertainties identified in Decibels filings with the Securities and Exchange Commission (SEC), including those risks detailed under the caption Risk Factors in Decibels Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022 and in other filings Decibel may make with the SEC. In addition, the forward-looking statements included in this press release represent Decibels views as of the date of this press release. Decibel anticipates that subsequent events and developments will cause its views to change. However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Decibels views as of any date subsequent to the date of this press release.

Investor Contact:Julie SeidelStern Investor Relations, Inc.julie.seidel@sternir.com212-362-1200

Media Contact:Chris RaileyTen Bridge CommunicationsChris@tenbridgecommunications.com617-834-0936

Originally posted here:

Decibel Therapeutics Receives FDA Clearance of IND Application for DB-OTO, a Gene Therapy Product Candidate Designed to Provide Hearing to Individuals...

GenScript ProBio Signs MOU to Form Strategic Partnership with GeneCraft To Development and Production of New AAV gene therapies – Yahoo Finance

Posted on by

SEOUL, South Korea, Oct. 18, 2022 /PRNewswire/ --On the Oct 17,2022, GenScript ProBio (Brian Ho-sung Min, CEO), a global CDMO, and GeneCraft (Suk Chul Bae, CEO),a global research team led by Professor Suk Chul Bae of lung cancer mechanism research, announced that they had entered into a strategic partnership MOU concerning the development and production of anew drugs needed for RX001.GenScript ProBio and GeneCraft have agreed to strengthen their cooperation in the AAV gene therapy field through this MOU.

Left Prof. Suk Chul Bae, CEO of GeneCraft / Right Dr. Brian H. Min CEO of GenScript ProBio

GenScript ProBio and GeneCraft are in the process of signing a contract for plasmid and AAV development and production for the GeneCraft's own new drug candidate Pan-KRAS non-small cell lung cancer anti-cancer gene therapy (RX001) developed as a new drug.With this agreement, GenScript ProBio has become a global partner that can support GeneCraft's various gene therapy pipelines.

Brian H. Min, CEO of GenScript ProBio said, "We are very happy to cooperate with GeneCraft in strategic partnership, and we are looking forward to accelerating the development of GeneCraft's gene therapy pipelines as a global partner through our accumulated technology."

Suk Chul Bae, CEO of GeneCraft Inc. said, "Through this strategic partnership with GeneScript ProBio, we look forward to successfully conducting the upcoming clinical trials of RX001, a first-in-class anticancer gene therapy. By establishing a long-term partnership we hope to become the global leaders in the gene therapy market."

About GeneCraftInc.GeneCraftInc.isaninnovativegenetherapydeveloperwithitsrootsincancerdefensemechanismsresearchedbyProfessorSukChulBae, a world renowned cancer research scholar. Genecraftisagloballeaderindevelopinggenetherapyproductswithitscontractdevelopment(CDO) platform specialized in improving the expression vector through viral expression recombination andcapsidmodification.

Story continues

About GenScript ProBio

GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers, and supported customers in the United States, Europe, Asia Pacific and other regions to obtain more than 30 IND approvals. Toward the mission of "Innovation through Collaboration", GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and building a healthier future.

http://www.genscriptprobio.com

SOURCE GenScript ProBio

Go here to read the rest:

GenScript ProBio Signs MOU to Form Strategic Partnership with GeneCraft To Development and Production of New AAV gene therapies - Yahoo Finance

Survey Reveals Most People with Spinal Muscular Atrophy Using New Gene Therapies, Focused on Treatment Pipeline – PR Newswire

Posted on by

Three in 10 respondents consider their SMA controlled, but 69% are hopeful additional treatment breakthroughs will occur in their lifetime

PHILADELPHIA, Oct. 18, 2022 /PRNewswire/ -- People with spinal muscular atrophy are relying on recently approved condition-specific treatments and are hopeful the treatment pipeline can continue to have a positive impact, according to a recent survey conducted by Health Union, the leader in social health. The inaugural Spinal Muscular Atrophy In America survey illuminates the perspectives and experiences of people living with spinal muscular atrophy.

These findings also support and fuel content and engagement for the recent launch of SpinalMuscularAtrophy.net, one of Health Union's 40 condition-specific online health communities.

Spinal muscular atrophy, or SMA, is a rare chronic condition, with research suggesting up to 25,000 people in the United States are living with the condition. According to the National Institute of Neurological Disorders and Stroke, SMA is an inherited condition that affects nerves and muscles, caused by a mutation in the survival motor neuron, or SMN, gene. Without the protein produced by the SMN gene, people with SMA lose motor neurons in their spinal cord, leading to weakness in the skeletal muscles and often making it harder to speak, walk, breathe and swallow.

Over the past six years, the U.S. Food and Drug Administration has approved the first three treatments specifically for spinal muscular atrophy. These gene therapy treatments increase the amount of SMN protein in the body. In fact, three-fourths of Spinal Muscular Atrophy In America survey respondents said they currently use an "SMN-enhancing" treatment, while another 19% said they previously used one.

SpinalMuscularAtrophy.net patient leader Allie Williams is using one of these SMN-enhancing treatments, which she says has stopped the progression of her spinal muscular atrophy while also helping her make "tremendous gains physically and mentally."

"It has improved my quality of life by letting me do things I wasn't able to do before, like feeding myself, drawing, painting, playing video games and doing my own makeup," Williams said. "Being more independent and being able to do more things I enjoy by myself has improved my happiness beyond measure."

Despite this progress in treatment, experiences differ, especially when factoring in condition progression and symptoms experienced. Only three in 10 respondents consider their SMA controlled under their current treatment plan, and 74% remain worried about their condition progressing.

With this in mind, it is unsurprising that the treatment pipeline remains a priority for people with SMA. When seeking information about their condition, respondents's top topics of interest - with the exception of assistive devices to improve daily life - all revolved around treatment, including new treatments in the pipeline, other SMA patients' experiences with treatments, research and clinical trials for SMA. On top of that, seven in 10 respondents said they are hopeful future treatment breakthroughs will happen in their lifetime.

Fortunately, two-thirds of respondents agree they have reliable access to medical care or treatment, although 44% said finances prevent them from receiving the care they need. Luckily, 44% said they are confident they're doing everything necessary - a mixture of treatments, specialists and other healthcare professionals, assistive devices and other life modifications - to manage their SMA on a regular basis.

"With a number of recently approved treatments already having an impact on quality of life and an intriguing treatment pipeline, people with spinal muscular atrophy are actively looking for accurate information, including the treatment experiences of others," said Olivier Chateau, Health Union's co-founder and CEO. "SpinalMuscularAtrophy.net provides a safe, supportive environment where people with the condition can find the information, connection and support they're looking for."

The inaugural Spinal Muscular Atrophy In America survey, which was fielded from April 19, 2021 to April 8, 2022, included responses from 54 people living with spinal muscular atrophy. Additional survey results may be available upon request. More information about living with spinal muscular atrophycan be found on SpinalMuscularAtrophy.net.

About Health Union

Health Unionis the proven industry leader driving and amplifying social health. As the premier social health company, only Health Union encourages the dynamic, real-time action people take to find meaningful connections and share information that impact their health journey. The company reaches millions of people through the largest portfolio of condition-specific online health communities (e.g., Migraine.com, MultipleSclerosis.net, LungCancer.net) and health leaders - addressing virtually every condition and providing the information, connection and support they need.

SOURCE Health Union

Go here to read the rest:

Survey Reveals Most People with Spinal Muscular Atrophy Using New Gene Therapies, Focused on Treatment Pipeline - PR Newswire

Gamma Biosciences, Lonza Enter Cell and Gene Therapy Alliance – Contract Pharma

Posted on by

Breaking News

BioMagnetic Solutions will supply research and cGMP manufacturing grade FerroSelect reagents to Lonza for use in developing CAR-T and other immunotherapeutics.

10.14.22

The collaboration provides a framework for additional clinical grade reagents to be developed and opens up the possibility of other collaborations as Gamma Biosciences expands its portfolio of tools and technologies supporting the bioprocessing, vaccine, cell and gene therapy industries.

"We are looking forward to working together with the team at Gamma Biosciences to offer cell and gene therapy developers added cell selection functionality on the Cocoon Platform" said Adam Bryan, Vice President of Personalized Medicines at Lonza. "The BioMagnetic Solutions ferrofluid technology provides efficient, high-performance cell selection reagents for research, clinical, and commercial-scale cell separations in a workflow that can be easily integrated into our automated, closed-system Cocoon manufacturing platform. This collaboration speaks to Lonza's commitment to expanding the flexibility and functionality of our automated manufacturing technology to address a broader range of needs for the cell therapy industry."

"We are thrilled to collaborate with Lonza in further developing and adapting FerroSelect reagents for use with the Cocoon Platform," said Phil Vanek, Chief Technology Officer at Gamma Biosciences. "The Lonza platform can be an alternative to our FerroSelect Array cell selection platform, demonstrating that our proprietary reagents can be applied to other automated manufacturing technologies. The agreement gives BioMagnetic Solutions technical direction on new applications, and access to some of the best process developers in the industry. In return, Lonza gains early access to certain BioMagnetic Solutions FerroSelect reagents to complement the growing demand for their Cocoon Platform technology."

Excerpt from:

Gamma Biosciences, Lonza Enter Cell and Gene Therapy Alliance - Contract Pharma