New law could allow big business to profit from organ donation

 As the Biden administration looks to upend the nation’s organ donation system, I have a question — and the answer will impact millions of lives: should entities be allowed to profit from one person’s decision to give the literal gift of life to another?

On July 27, Congress passed legislation that, for the first time, allows for-profit companies control over our nation’s transplant system under contract with the federal government. The bill eliminates three rules that have been in place since the 1980s to make sure our system, built on the backs of people’s willingness to donate organs, is free from incentives to make money off their altruism:

1. Only non-profit entities may be awarded government contracts to run this system.
2. They must have expertise in organ donation and transplantation.
3. The annual funds awarded through these government contracts cannot exceed a specified upper limit, which is currently $7,000,000. The for-profit bill lifts that cap entirely.

With Congress’ passage of the bill and President Biden’s signature, for-profits will be eligible to run everything from the transplant patient waitlist to system policymaking that governs how the system operates nationwide. In short, it could lead to a for-profit donation system. The very term is a dangerous oxymoron with potentially fatal consequences for transplant patients, particularly patients of color who are at higher risk for developing organ failure — and have historically suffered most within profit-driven systems.

As a Black transplant surgeon with five decades of experience, I have spent my entire career fighting to improve the organ donation and transplant field in this country. I founded the National Minority Organ Tissue Transplant Education Program to increase transplant education and improve organ donation rates among minority communities. This work, which has been my lifelong passion, predates the system itself.

I also served on the Task Force on Organ Transplantation, which was established to guide the transplant system’s development after it was first formed by the National Organ Transplant Act enacted by Congress in 1984. We determined early on that the system must be led by non-profit interests, dedicated only to the needs of patients and with no concern for shareholders, market shares or profits. We made this clear to Congress in our 1986 Report of the Task Force on Organ Transplantation and they listened to us at the time. That’s why the rules, noted above, were established and why they have been in place ever since. Until now.

Given my deep concerns about a bill that opens the door to profiteering off of organ donation, I have connected with numerous colleagues about its dire consequences. We delivered a letter to 135 congressional offices calling for this legislation to be revised to restore the non-profit requirement for contracting with the government to operate the system. We aren’t alone: Over 26,000 patients, donors and concerned citizens also have caught wind of this development and are petitioning the federal government to prevent for-profit companies from running America’s Organ Procurement and Transplantation Network (OPTN).

Such an outcome will negatively impact both sides of what sadly becomes an equation. Under the current system, the non-profit entities responsible for recovering organs will go to any lengths to ensure donor and donor family wishes are carried out, regardless of costs. They operate under the principle that they owe this to donors, whose sacred gifts make the system possible in the first place.

I am a transplant surgeon, not a CFO, but it doesn’t require an MBA to envision that a system run by for-profits will shift focus from organ recovery at any cost to a cost-benefit analysis of every organ. Trust will erode, organ registration will go down, there will be fewer organs available, and fewer lives will be saved.

I see a place for for-profit companies within our massive and complex system, particularly for highly specialized fields to help the system as a whole improve efficiencies, such as IT. However, the laws, policies and practices that ensure equity for all Americans seeking transplant and seek the highest and best uses of their gifts must be free from profit motives.

My colleagues and I are fully supportive of system improvement and reforms to save more lives, but the current path we’re on will lead only to tragedy. I urge Congress and President Biden to reconsider whether their actions will truly lead to a better organ donation system than the one we already have. The federal government must engage in a dialogue with medical experts and thousands of others who are begging to be heard on this issue before condemning organ donation to a profit-driven future.

Clive O. Callender, M.D., FACS is a surgeon and professor of surgery at Howard University and founder of the National Minority Organ Tissue Transplant Education Program. As a member of the Task Force on Organ Transplantation, he helped guide the creation of the U.S. Organ Procurement and Transplantation Network and has since led efforts against discriminatory policies in organ donation. 

https://thehill.com/opinion/congress-blog/4216808-new-law-could-allow-big-business-to-profit-from-organ-donation/

Biden: First US Abrams tanks to arrive in Ukraine next week

 The first U.S. Abrams tanks allocated for Ukraine will arrive there next week, President Biden said during a White House meeting with Ukrainian President Volodymyr Zelensky.

Biden vowed during the meeting with Zelensky and other officials from Ukraine and the White House that his administration would continue to support the war effort against invading Russian forces.

The president said Thursday he approved the next tranche of U.S. security assistance for Ukraine, which included additional artillery and ammunition, launchers and interceptors and more anti-tank weapons.

The president in January agreed to send 31 Abrams tanks to help Ukrainian forces defend themselves from Russia’s invasion, a reversal from when the administration initially argued the tanks would be of little benefit to Ukraine. The tanks had to be procured, and Ukrainian forces had to be trained on the machines.

The U.S. is also focused on improving Ukraine’s air defense capabilities so it can protect infrastructure that provides heat and light as it prepares for winter.

Biden in prepared remarks said ongoing U.S. support for Ukraine is about “the future of freedom.”

“America can never, will never walk away from that,” he said. “That’s why 575 days later, we stand with Ukraine, and we’ll continue to stand with Mr. President.”

“Mr. President, we’re with you. And we’re staying with you,” he added.

Zelensky’s visit to Washington on Thursday came as the Biden administration sent Congress a supplemental funding request that includes another $24 billion in military, humanitarian and financial assistance for Ukraine.

The U.S. has already provided billions of dollars in aid to Ukraine, with Biden making the argument that Russia’s invasion is a threat to democracy globally, and Russian President Vladimir Putin would look to invade another country if it successfully takes Ukraine.

But a minority of Republicans in Congress and some leading presidential candidates, including former President Trump, have pushed back on continued funding for Ukraine, arguing it is not in the United States’ interests to be sending money to the war-torn nation to fight Russia.

More than two dozen Republican lawmakers wrote to Biden ahead of Zelensky’s visit on Thursday, saying they oppose additional spending for Ukraine.

Speaker Kevin McCarthy (R-Calif.) has said that he would like to see the $24 billion supplemental request for Ukraine be brought to a vote as a stand-alone bill, as opposed to attaching it to additional government funding that Ukraine’s supporters feel would allow the assistance to more easily pass through the chaotic Congress.

https://thehill.com/homenews/administration/4217317-biden-first-us-abrams-tanks-to-arrive-in-ukraine-next-week/

White House to propose removing medical bills from credit reports

 The Biden-Harris administration announced Thursday it has begun looking into removing medical debt from consumer credit reports in an effort to lessen the impact unexpected medical costs can have on people and help them recover from the expenses, which can be immense.

In a press release, the Consumer Financial Protection Bureau (CFPB) said the proposal would help to “stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.”

Collection agencies, which often purchase debt from creditors for pennies on the dollar, have frequently been accused of employing overly aggressive tactics and sometimes taking legal action against patients. In some cases, the person being contacted by the agency may not even have any outstanding fees.

In a report from last year, the CFPB found that medical debt is the most common collection type found on credit reports, showing up disproportionately more when compared to other forms of debt.

“Research shows that medical bills have little predictive value in credit decisions, yet tens of millions of American households are dealing with medical debt on their credit reports,” CFPB Director Rohit Chopra said in a statement.

“When someone gets sick, they should be able to focus on getting better, rather than fighting debt collectors trying to extort them into paying bills they may not even owe.”

While the Fair Credit Reporting Act of 1970 restricts the sharing of medical information, exemptions passed in the early 2000s permitted creditors to obtain medical information in connection with credit eligibility determinations.

Under the proposal, consumer reporting companies would be blocked from using medical debts and collection information on consumer reports. Creditors would also be barred from using medical debt for underwriting decisions and debt collectors would no longer be able to use what the CFPB referred to as “coercive collection practice.”

In a press briefing, Vice President Harris noted that more than one out of three U.S. adults struggle with medical debt, a disproportionate number of whom are from communities of color. Harris said this action would allow for more people to qualify for loans to purchase cars or homes or to qualify for rent.

Senior administration officials said Wednesday that they will solicit feedback from small businesses that may be affected by the proposed rule. The officials said the administration plans to proceed “expeditiously” and is aiming to propose the rule next year.

https://thehill.com/homenews/4217061-white-house-to-propose-removing-medical-bills-from-credit-reports/

Mexican cartels rank as nation’s fifth-largest employer: study

 Mexican cartels have seen a surge in growth in their participating members over the last decade, according to a new study, to the point where they have effectively become the nation’s fifth-largest employer.

Researchers created a mathematical model using homicide, missing persons and incarceration data to track cartel recruitment. Their study, published Thursday in the journal Science, found that some 175,000 people in Mexico are employed by 150 different cartel groups. 

The researchers said they hope their study can help analysts and governments who “have long struggled to understand cartels” and find a “better way out of this cycle of violence.” 

In the last ten years, 37 percent of known cartel members had been killed or incarcerated, and yet the size of cartels grew. The researchers found they must have recruited nearly 20,000 members a year to make up for losses. 

An unrelated report released by the U.S. Drug Enforcement Administration in July estimated that the two largest cartels, Sinaloa and Jalisco New Generation, employed more than 44,800 people. The study’s author, Rafael Prieto-Curiel, a former Mexico City police officer, said his model showed a similar number of 46,000 cartel members in those two groups. 

Neither of those numbers might be fully representative of the total number though, the Thursday report said. 

“The model only accounts for those directly involved in work that puts them at risk of violence, and not members—such as bankers—who help move and launder cartels’ money,” it stated. 

Victoria Dittmar, a researcher for Insight Crime who did not take part in the study, told The Guardian that the numbers depend on the definition of a cartel and what constitutes membership. 

“It can be very difficult to say who is a member of a criminal organization and who isn’t,” Dittmar said. “What about a politician that receives money? Or someone who cooperates with the group just once?”

Other researchers have said Prieto-Curiel’s July study is a breakthrough because previous attempts to fight organized crime by the cartels have failed — and the study has shown combatting the crime starts with decreasing the cartels’ ability to recruit new members.

“At least we know we have to focus on that question rather than just sending more money to armed forces and building prisons,” said Carlos Gershenson, a computer scientist at Binghamton University who did not participate in the research. “You need to cut the source of the problem rather than dealing with the consequences.”

https://thehill.com/policy/international/4217279-mexican-cartels-rank-as-nations-fifth-largest-employer-study/

Cal. sues organizations promoting unproven abortion pill reversal treatment

 California sued two organizations over unproven treatments that claim to reverse medication abortions in the state’s Superior Court in Alameda County Thursday.

“Those who are struggling with the complex decision to get an abortion deserve support and trustworthy guidance — not lies and misinformation,” California Attorney General Robert Bonta (D) said in a statement. “And let me be clear: the evidence shows that the vast majority of people do not regret their decision to have an abortion — more than 95% of patients who undergo an abortion later say they made the right decision.

In the complaint obtained by CalMatters, the state takes aim at Heartbeat International, Inc., an anti-abortion charity that has a “network of pro-life pregnancy resource centers,” according to its website and RealOptions Obria, a group that operates five clinics in Northern California, according to its website. The state accuses the two organizations of giving “vulnerable pregnant people” incorrect information about the treatments.

“They claim that there is a way to ‘reverse’ the effects of mifepristone, which they call ‘abortion pill reversal’ or ‘APR,’” the complaint reads. “They further claim—falsely—that through APR ‘thousands of lives’ have been ‘saved.’ But, there is no evidence showing that mifepristone can be ‘reversed’ or that the APR ‘protocol’ contributes to the continuation of a pregnancy.”

The American College of Obstetricians and Gynecologists said the treatments are not “based on science and do not meet clinical standards” on their website. 

“Despite this, in states across the country, politicians are advancing legislation to require physicians to recite a script that a medication abortion can be ‘reversed’ with doses of progesterone, to cause confusion and perpetuate stigma, and to steer women to this unproven medical approach,” the page reads. “Unfounded legislative mandates like this one represent dangerous political interference and compromise patient care and safety.”

In an emailed statement, Heartbeat International said they learned about the suit via “interview requests” and “have not been served at this point.”

“Through our Abortion Pill Rescue Network hotline, we know that some women almost immediately regret their chemical abortion choice,” Heartbeat International’s statement read. “These women deserve the right to try and save their pregnancies. No woman should ever be forced to complete an abortion she no longer wants.”

https://thehill.com/homenews/state-watch/4217334-california-files-lawsuit-against-organizations-promoting-unproven-abortion-pill-reversal-treatment/

Shared molecular mechanisms across SARS-CoV-2 variants that allow virus to thrive despite vaccination

 In a study published online in Cell , scientists at UCSF QBI, University College London and the Icahn School of Medicine at Mount Sinai reported breakthrough findings on convergent evolutionary mechanisms shared by COVID-19 variants, allowing them to overcome both adaptive and innate immune system barriers.

In the paper titled, SARS-CoV-2 Variants Evolve Convergent Strategies to Remodel the Host Response, published in Cell, scientists carried out an unprecedented, systematic comparative study using the most infectious COVID-19 variants, namely alpha, beta, gamma, delta and omicron to identify specific viral mutations responsible for hijacking a common host pathway, thereby leading to increased transmissibility, infectivity and survival.

Specifically, they discovered a convergence in potent suppression of interferon-stimulated genes through several viral proteins, including Orf6 and Orf9b, which serve as innate immune antagonist proteins capable of blocking innate host immune response.

The study, led by the laboratories of Nevan Krogan, Ph.D., Director of the Quantitative Biosciences Institute (QBI) at the School of Pharmacy at UC San Francisco, Senior Investigator at Gladstone Institutes, was a collaborative effort that involved 16 institutions in six countries, including University College London (UCL) in London, England (Greg Towers and Clare Jolly) and Icahn Mount Sinai (Adolfo Garcia-Sastre and Lisa Miorin) among others.

"Unfortunately, we continue to see new mutations and strains of SARS-CoV-2 despite innovations in new vaccines," said Dr. Krogan, who founded the QBI Coronavirus Research Group (QCRG).

"We evaluated each of the viral variants in isolation and discovered that there was a common mechanism involving several viral proteins, including Orf6 and Orf9b, that potently suppresses innate immunity. This finding is consistent with our investigation of early SARS-CoV-2 variants where certain viral proteins were highly expressed in infected cells which helped the virus infect our cells."

"With our additional research across SARS-CoV-2 variants, we now see this as a crucial finding that, if targeted effectively, could be turned into a significant vulnerability for this virus, which also has important implications for management of future pandemics."

In a second paper, titled "Impact of SARS-CoV-2 Orf6 and its variant polymorphisms on host responses and viral pathogenesis," also published in Cell Host & Microbe, the researchers further detailed the role of Orf6 in subverting important pathways involved in the host antiviral response.

"In this study we found that Orf6 is a major SARS-CoV-2 innate immune antagonist by selectively interfering with nucleocytoplasmic trafficking through direct interactions with the nuclear pore complex," said Lisa Miorin, Ph.D., Assistant Professor Department of Microbiology at Mount Sinai.

"We show that the absence of ORF6, or the introduction of ORF6 loss-of-function mutations, significantly influences the host antiviral responses resulting in SARS-CoV-2 attenuation in animal models."

Adolfo García-Sastre, Ph.D., Professor of Medicine (Infectious Diseases), Microbiology and Pathology, Molecular and Cell Based Medicine and Director of the Global Health and Emerging Pathogens Institute at Mount Sinai added, "These observations provide a potential new way to address viral pandemics by targeting a common pathway that the virus uses for infectivity, a different approach from vaccines that are created to target mutated Spike proteins within individual variants."

"By investigating the variant's ability to suppress the host immune response we have uncovered what appears to be a mechanism that viruses use that can be exploited."

Mehdi Bouhaddou, Ph.D., Assistant Professor Department of Microbiology, Immunology, and Molecular Genetics at the University of California, Los Angeles (UCLA) who contributed to the research during his prior post-doctoral fellowship at UCSF commented, "Similar to treatment regimens for HIV, we believe the future approach to managing pandemics will require a drug combination cocktail."

"Here, this could include a combination of vaccines and antiviral innovations to target the virus. Specifically, combination therapy approaches to target the adaptive immune response (e.g., vaccines, antibody treatments) and another inhibiting viral innate immune antagonist proteins (e.g., Orf6 and Orf9b) or activating the innate immune response, could be the most effective. Perhaps with this approach, we may be able to get ahead of viruses before they reach pandemic levels."

To understand the effect of viral mutations on viral replication and cellular responses, the researchers systematically studied the five SARS-CoV-2 variants of concern during infection in human airway epithelial cells. Their analysis pinpointed cellular pathways that are similarly modulated across variants during infection and represent putative targets for pan-coronavirus antivirals.

They observed most of the variants improve their ability to inhibit the host innate immune response, which likely contributed to variant dominance by improving transmission. They reason this reflects a strong selection imposed by the human innate immune system on the virus, whose ancestor likely adapted to evade innate immunity in a non-human species.

The researchers concluded that a major force in shaping SARS-CoV-2 virus-host adaptations is related to evasion of innate and adaptive responses, a finding that has also been shown in research evasion of innate immune responses in HIV.

More information: Nevan J. Krogan, SARS-CoV-2 variants evolve convergent strategies to remodel the host response, Cell (2023). DOI: 10.1016/j.cell.2023.08.026. www.cell.com/cell/fulltext/S0092-8674(23)00915-7

Lisa Miorin, Impact of SARS-CoV-2 ORF6 and its variant polymorphisms on host responses and viral pathogenesis, Cell Host & Microbe (2023). DOI: 10.1016/j.chom.2023.08.003. www.cell.com/cell-host-microbe … 1931-3128(23)00328-1

https://medicalxpress.com/news/2023-09-molecular-mechanisms-sars-cov-variants-virus.html

Regeneration across complete spinal cord injuries reverses paralysis

 When the spinal cords of mice and humans are partially damaged, the initial paralysis is followed by the extensive, spontaneous recovery of motor function. However, after a complete spinal cord injury, this natural repair of the spinal cord doesn't occur and there is no recovery. Meaningful recovery after severe injuries requires strategies that promote the regeneration of nerve fibers, but the requisite conditions for these strategies to successfully restore motor function have remained elusive.

"Five years ago, we demonstrated that nerve fibers can be regenerated across anatomically complete spinal cord injuries," says Mark Anderson, a senior author of the study. "But we also realized this wasn't enough to restore motor function, as the new fibers failed to connect to the right places on the other side of the lesion." Anderson is the director of Central Nervous System Regeneration at .NeuroRestore and a scientist at the Wyss Center for Bio and Neuroengineering.

Working in tandem with peers at UCLA and Harvard Medical School, the scientists used state-of-the-art equipment at EPFL's Campus Biotech facilities in Geneva to run in-depth analyses and identity which type of neuron is involved in natural spinal-cord repair after partial spinal cord injury.

"Our observations using single-cell nuclear RNA sequencing not only exposed the specific axons that must regenerate, but also revealed that these axons must reconnect to their natural targets to restore motor function," says Jordan Squair, the study's first author. The team's findings appear in the journal Science.

Towards a combination of approaches

Their discovery informed the design of a multipronged gene therapy. The scientists activated growth programs in the identified neurons in mice to regenerate their nerve fibers, upregulated specific proteins to support the neurons' growth through the lesion core, and administered guidance molecules to attract the regenerating nerve fibers to their natural targets below the injury.

"We were inspired by nature when we designed a therapeutic strategy that replicates the spinal-cord repair mechanisms occurring spontaneously after partial injuries," says Squair.

Mice with anatomically complete spinal cord injuries regained the ability to walk, exhibiting gait patterns that resembled those quantified in mice that resumed walking naturally after partial injuries. This observation revealed a previously unknown condition for regenerative therapies to be successful in restoring motor function after neurotrauma.

"We expect that our gene therapy will act synergistically with our other procedures involving electrical stimulation of the spinal cord," says Grégoire Courtine, a senior author of the study who also heads .NeuroRestore together with Jocelyne Bloch.

"We believe a complete solution for treating spinal cord injury will require both approaches—gene therapy to regrow relevant nerve fibers, and spinal stimulation to maximize the ability of both these fibers and the spinal cord below the injury to produce movement."

While many obstacles must still be overcome before this gene therapy can be applied in humans, the scientists have taken the first steps towards developing the technology necessary to achieve this feat in the years to come.

More information: Jordan W. Squair et al, Recovery of walking after paralysis by regenerating characterized neurons to their natural target region, Science (2023). DOI: 10.1126/science.adi6412. www.science.org/doi/10.1126/science.adi6412

https://medicalxpress.com/news/2023-09-regeneration-spinal-cord-injuries-reverses.html#google_vignette