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Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair

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by Arthur Allen
Thu, 23 Mar 2023 22:15:00 +0000

Sen. Bernie Sanders, who rose to national prominence criticizing big business in general and the pharmaceutical industry in particular, claimed the spotlight Wednesday on what might at first seem a powerful new stage from which to advance his agenda: chairmanship of the Senate health committee.

But the hearing Sanders used to excoriate a billionaire pharmaceutical executive for raising the price of a covid-19 vaccine showed the challenges the Vermont independent faces.

Though its formal name is the Committee on Health, Education, Labor, and Pensions (), the panel Sanders chairs has little if any authority over drug prices. In the Senate, most of that leverage lies with the Finance Committee, which oversees , Medicare, and Obamacare.

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As far as drug prices go, the platform Sanders commands is essentially a bully pulpit. So Sanders was left to bully his way toward results. And while some committee Republicans sympathized with his complaints, others bristled at his approach.

By the end of the hearing, seeming to acknowledge the limits of his power, the former presidential candidate was pleading with Moderna chief executive Stéphane Bancel for a relatively modest concession on vaccine pricing.

The CEO made no promises. Then again, pulpit proclamations can to corporate action, even if delayed and informal; in the weeks following 's of the Union call for cheaper insulin, the companies that make it drastically cut their prices.

Sanders began Wednesday's hearing with his usual fire and brimstone.

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“All over this country people are getting sicker, and in some cases dying, because they can't afford the outrageous cost of prescription , while companies make huge profits and executives become billionaires,” Sanders thundered.

Bancel had won his place in the witness chair with federal assistance. Moderna, which was founded in 2010 and had not brought a drug to market before the pandemic, received billions in government funds for research, guaranteed purchases, and expert advice to help develop and produce its successful covid vaccine. The payoff has been handsome. As of March 8, Bancel held $3 billion in Moderna stock. He also held options to buy millions of additional shares.

Government research and support are foundational to many of the expensive drugs and vaccines in use . But Bancel made himself the perfect foil for Sanders when he announced in January that Moderna planned to increase the price of its latest covid shot from about $26 to $110 — or as much as $130.

Denouncing greed, Sanders expounded on his dream of a system in which the government fully funds drug development — and in exchange controls drug prices. “Is there another model out there where, when a lifesaving drug is made, it becomes accessible to all those who need it?” he asked. “What am I missing in thinking that it's cruel to make a medicine that people can't afford?'”

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Sanders' overt moralizing and harsh attacks on big business make him an outlier in the Senate, even in his own party. Yet distaste for soaring drug prices extends across the aisle. On the HELP Committee, at least, Republican politicians seem about evenly split between populist and pro-business takes on the problem, showing both the possibilities and the pitfalls that Sanders faces.

Sen. Mike Braun (R-Ind.) expressed disgust with the lack of transparency in the health care system and called Moderna's planned price hike “preposterous.” Sen. Roger Marshall (R-Kan.) called it “outrageous.”

Sen. Rand Paul (R-Ky.), who often bucks mainstream GOP views and has expressed rancor for the biomedical establishment, claimed Bancel was downplaying vaccine injuries to make money. (Paul vastly exaggerated those risks.)

Ranking member Bill Cassidy (R-La.), who has pledged to work with Sanders, responded to the chairman's opening remarks with both a hedge and a warning. “I'm not defending salaries or profits,” Cassidy said, but he added that he hoped the hearing's goal wasn't to “demonize capitalism.”

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Only Sen. Mitt Romney (R-Utah), a former private equity executive, came heartily to Bancel's defense. “If I'm an investor, I have to expect that if a product I'm backing works, I get to make an awful lot of money,” he said. “I've heard people say, ‘That's corporate greed.' Yeah, that's how it works.”

Sanders' idealized vision of the pharmaceutical industry is, in any case, moot. Even the Biden administration, which successfully browbeat insulin makers into drastically lowering prices in March, revealed this week it would not use “march-in” rights to lower the price of a cancer drug, Xtandi, developed with government-licensed patents.

March-in rights were established in the 1980 Bayh-Dole Act, which enabled companies to license federally funded research and use it to develop drugs. But federal courts and administrations have consistently said the government can seize a product only if the license holder has failed to make it available — not because the price is too high. The administration did, however, announce a review of whether price might be considered in future march-in decisions.

Sanders said before the hearing that he was “extremely disappointed” with the Xtandi decision. But he was ultimately realist enough to aim his bully pulpit at a lower target. Late in Wednesday's hearing, Sanders pushed for a minimal gimme from Moderna. “Will you reconsider your decision to quadruple the price of your vaccine to the U.S. government and its agents?” he asked politely.

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Bancel dodged, saying pricing was more complex now that Moderna faced an uncertain market, had to fill separate syringes with its vaccine, and needed to sell and distribute the vaccine to thousands of pharmacies, where previously the government did all that work. Later, he left open the possibility that negotiations could drive down the price paid by some government agencies or private insurers.

For all the theatrics of such hearings and the mix of opinions among the senators, interrogations of figures like Bancel may help inspire a shift in how the National Institutes of Health “does business in giving away its science to the private sector,” said Tahir Amin, co-executive director of I-MAK, a nonprofit that advocates for equitable access to medicines.

“You have to prosecute it so you at least get these public comments on record,” Amin said. Eventually, he said, this type of hearing could lead to a recognition that, ‘Hey, we need to do this.'”

Despite the HELP Committee's lack of direct jurisdiction over drug prices, said John McDonough, a Harvard professor who was senior adviser for health reform on the HELP Committee from 2008 to 2010, Sanders “uses his position of authority and influence to draw attention to this in a way that has been helpful.”

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KHN correspondent Rachana Pradhan contributed to this report.

KHN (Kaiser Health ) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This story can be republished for (details).

By: Arthur Allen
Title: Sen. Sanders Shows Fire, but Seeks Modest Goals, in His Debut Drug Hearing as Health Chair
Sourced From: khn.org/news/article/senate-moderna-hearing-bernie-sanders-stephane-bancel-drug-costs/
Published Date: Thu, 23 Mar 2023 22:15:00 +0000

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Kaiser Health News

KFF Health News’ ‘What the Health?’: Abortion — Again — At the Supreme Court

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Wed, 24 Apr 2024 20:30:00 +0000

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

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Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news , “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “ Politics and Policy A to Z,” now in its third edition.

Some justices suggested the Supreme Court had said its piece on abortion law when it overturned in 2022. This term, however, the court has agreed to review another abortion case. At issue is whether a federal law requiring emergency care in hospitals overrides Idaho's near-total abortion ban. A decision is expected by summer.

Meanwhile, the Centers for Medicare & Medicaid finalized the first-ever minimum staffing requirements for nursing homes participating in the programs. But the industry argues that there are not enough workers to hire to meet the standards.

This week's panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins 's nursing and public health schools and Politico Magazine, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

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Panelists

Joanne Kenen
Johns Hopkins University and Politico


@JoanneKenen


Read Joanne's articles.

Tami Luhby
CNN

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@Luhby


Read Tami's stories.

Alice Miranda Ollstein
Politico


@AliceOllstein

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Read Alice's stories.

Among the takeaways from this week's episode:

  • This week's Supreme Court hearing on emergency abortion care in Idaho was the first challenge to a 's abortion ban since the overturn of the constitutional right to an abortion. Unlike previous abortion cases, this one focused on the everyday impacts of bans on abortion care — cases in which pregnant experienced medical emergencies.
  • Establishment medical groups and doctors themselves are getting more vocal and active as states set laws on abortion access. In a departure from earlier political moments, some major medical groups are campaigning on state ballot measures.
  • Medicaid officials this week finalized new rules intended to more closely regulate managed-care plans that enroll Medicaid patients. The rules are intended to ensure, among other things, that patients have prompt access to needed primary care doctors and specialists.
  • Also this week, the Federal Trade Commission voted to ban most “noncompete” clauses in employment contracts. Such language has become common in health care and prevents not just doctors but other health workers from changing — often forcing those workers to move or commute to a position. Business interests are already suing to block the new rules, they would be too expensive and risk the loss of proprietary information to competitors.
  • The fallout from the cyberattack of Change Healthcare continues, as yet another group is demanding ransom from UnitedHealth Group, Change's owner. UnitedHealth said in a statement this week that the records of “a substantial portion of America” may be involved in the breach.

Plus for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: NBC News' “Women Are Less Likely To Die When Treated by Female Doctors, Study Suggests,” by Liz Szabo.  

Alice Miranda Ollstein: States Newsroom's “Loss of Federal Protection in Idaho Spurs Pregnant Patients To Plan for Emergency Air Transport,” by Kelcie Moseley-Morris.  

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Tami Luhby: The Associated Press' “Mississippi Lawmakers Haggle Over Possible Medicaid Expansion as Their Legislative Session Nears End,” by Emily Wagster Pettus.  

Joanne Kenen: States Newsroom's “Missouri Prison Agency To Pay $60K for Sunshine Law Violations Over Inmate Death Records,” by Rudi Keller.  

Also mentioned on this week's podcast:

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Francis Ying
Audio producer

Emmarie Huetteman
Editor

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To hear all our , click here.

And subscribe to KFF Health News' “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

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Title: KFF Health News' ‘What the Health?': Abortion — Again — At the Supreme Court
Sourced From: kffhealthnews.org/news/podcast/what-the-health-344-abortion-supreme-court-april-25-2024/
Published Date: Wed, 24 Apr 2024 20:30:00 +0000

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Mandatory Reporting Laws Meant To Protect Children Get Another Look

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Kristin Jones
Thu, 25 Apr 2024 09:00:00 +0000

More than 60 years ago, policymakers in Colorado embraced the idea that early intervention could prevent child abuse and save lives. The state's requirement that certain professionals tell when they suspect a child has been abused or neglected was among the first mandatory reporting laws in the nation.

Since then, mandatory reporting laws have expanded nationally to include more types of maltreatment — neglect, which now accounts for most reports — and have increased the number of professions required to report. In some states, all adults are required to report what they suspect may be abuse or neglect.

But now there are efforts in Colorado and other states to roll back these laws, saying the result has been too many unfounded reports, and that they disproportionately harm families that are poor, Black, or Indigenous, or have members with disabilities.

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“There's a long, depressing history based on the approach that our primary response to a struggling family is reporting,” said Mical Raz, a physician and historian at the University of Rochester in New York. “There's now a wealth of evidence that demonstrates that more reporting is not associated with better outcomes for children.”

Stephanie Villafuerte, Colorado's child protection ombudsman, oversees a task force to reexamine the state's mandatory reporting laws. She said the group is seeking to balance a need to report legitimate cases of abuse and neglect with a desire to weed out inappropriate reports.

“This is designed to individuals who are disproportionately impacted,” Villafuerte said. “I'm hoping it's the combination of these efforts that could make a difference.”

Some critics worry that changes to the could result in missed cases of abuse. Medical and child care workers on the task force have expressed concern about legal liability. While it's rare for people to be criminally charged for failure to report, they can also face civil liability or professional repercussions, including threats to their licenses.

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Being reported to child protective services is becoming increasingly common. More than 1 in 3 children in the United States will be the subject of a child abuse and neglect investigation by the time they turn 18, according to the most frequently cited estimate, a 2017 study funded by the Department of Health and Human Services' Children's .

Black and Native American families, poor families, and parents or children with disabilities experience even more oversight. Research has found that, among these groups, parents are more likely to lose parental rights and children are more likely to wind up in foster care.

In an overwhelming majority of investigations, no abuse or neglect is substantiated. Nonetheless, researchers who study how these investigations affect families describe them as terrifying and isolating.

In Colorado, the number of child abuse and neglect reports has increased 42% in the past decade and reached a record 117,762 last year, according to state data. Roughly 100,000 other calls to the hotline weren't counted as reports because they were requests for information or were about matters like child or adult protection, said officials from the Colorado Department of Human Services.

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The increase in reports can be traced to a policy of encouraging a broad array of professionals — including school and medical staff, therapists, coaches, clergy members, firefighters, veterinarians, dentists, and social workers — to call a hotline whenever they have a concern.

These calls don't reflect a surge in mistreatment. More than two-thirds of the reports received by agencies in Colorado don't meet the threshold for investigation. Of the children whose cases are assessed, 21% are found to have experienced abuse or neglect. The actual number of substantiated cases has not risen over the past decade.

While studies do not demonstrate that mandatory reporting laws keep children safe, the Colorado task force reported in January, there is evidence of harm. “Mandatory reporting disproportionately impacts families of color” — initiating contact between child protection services and families who routinely do not present concerns of abuse or neglect, the task force said.

The task force said it is analyzing whether better screening might mitigate “the disproportionate impact of mandatory reporting on under-resourced communities, communities of color and persons with disabilities.”

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The task force pointed out that the only way to report concerns about a child is with a formal report to a hotline. Yet many of those calls are not to report abuse at all but rather attempts to connect children and families with resources like food or housing assistance.

Hotline callers may mean to help, but the families who are the subjects of mistaken reports of abuse and neglect rarely see it that way.

That includes Meighen Lovelace, a rural Colorado who asked KFF Health not to disclose their hometown for fear of attracting unwanted attention from local officials. For Lovelace's daughter, who is neurodivergent and has physical disabilities, the reports started when she entered preschool at age 4 in 2015. The teachers and medical providers making the reports frequently suggested that the county human services agency could assist Lovelace's family. But the investigations that followed were invasive and traumatic.

“Our biggest looming fear is, ‘Are you going to take our children away?'” said Lovelace, who is an advocate for the Colorado Cross-Disability Coalition, an organization that lobbies for the of people with disabilities. “We're afraid to ask for help. It's keeping us from entering services because of the fear of child welfare.”

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State and county human services officials said they could not comment on specific cases.

The Colorado task force plans to suggest clarifying the definitions of abuse and neglect under the state's mandatory reporting statute. Mandatory reporters should not “make a report solely due to a family/child's race, class or gender,” nor because of inadequate housing, furnishings, income or clothing. Also, there should not be a report based solely on the “disability status of the minor, parent or guardian,” according to the group's draft recommendation.

The task force plans to recommend additional training for mandatory reporters, help for professionals who are deciding whether to make a call, and an alternative phone number, or “warmline,” for cases in which callers believe a family needs material assistance, rather than surveillance.

Critics say such changes could leave more children vulnerable to unreported abuse.

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“I'm concerned about adding systems such as the warmline, that kids who are in real danger are going to slip through the cracks and not be helped,” said Hollynd Hoskins, an attorney who represents victims of child abuse. Hoskins has sued professionals who fail to report their suspicions.

The Colorado task force includes health and education officials, prosecutors, victim advocates, county child welfare representatives and attorneys, as well as five people who have experience in the child welfare system. It intends to finalize its recommendations by early next year in the hope that state legislators will consider policy changes in 2025. Implementation of any new laws could take several years.

Colorado is one of several states — including New York and California — that have recently considered changes to restrain, rather than expand, reporting of abuse. In New York City, teachers are being trained to think twice before making a report, while New York state introduced a warmline to help connect families with resources like housing and child care. In California, a state task force aimed at shifting “mandated reporting to community supporting” is planning recommendations similar to Colorado's.

Among those advocating for change are people with experience in the child welfare system. They include Maleeka Jihad, who leads the Denver-based MJCF Coalition, which advocates for the abolition of mandatory reporting along with the rest of the child welfare system, citing its damage to Black, Native American, and Latino communities.

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“Mandatory reporting is another form of keeping us policed and surveillanced by whiteness,” said Jihad, who as a child was taken from the care of a loving parent and placed temporarily into the foster system. Reform isn't enough, she said. “We know what we need, and it's usually funding and resources.”

Some of these resources — like affordable housing and child care — don't exist at a level sufficient for all the Colorado families that need them, Jihad said.

Other services are out there, but it's a matter of finding them. Lovelace said the reports ebbed after the family got the help it needed, in the form of a Medicaid waiver that paid for specialized care for their daughter's disabilities. Their daughter is now in seventh grade and doing well.

None of the caseworkers who the family ever mentioned the waiver, Lovelace said. “I really think they didn't know about it.”

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——————————
By: Kristin Jones
Title: Mandatory Reporting Laws Meant To Protect Children Get Another Look
Sourced From: kffhealthnews.org/news/article/child-abuse-mandatory-reporting-laws-colorado/
Published Date: Thu, 25 Apr 2024 09:00:00 +0000

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Genetics Studies Have a Diversity Problem That Researchers Struggle To Fix

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Lauren Sausser
Thu, 25 Apr 2024 09:00:00 +0000

CHARLESTON, S.C. — When he recently walked into the dental clinic at the Medical University of South Carolina donning a bright-blue pullover with “In Our DNA SC” embroidered prominently on the front, Lee Moultrie said, two Black women stopped him to ask questions.

“It's a walking billboard,” said Moultrie, a advocate who serves on the community advisory board for In Our DNA SC, a study underway at the university that aims to enroll 100,000 South Carolinians — a representative percentage of Black people — in genetics research. The goal is to better understand how genes affect health risks such as cancer and heart disease.

Moultrie, who is Black and has participated in the research himself, used the opportunity at the dental clinic to encourage the women to sign up and contribute their DNA. He keeps brochures about the study in his car and at the barbershop he visits weekly for this reason. It's one way he wants to help solve a problem that has plagued the field of genetics research for decades: The data is based mostly on DNA from white people.

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Project leaders in Charleston told KFF Health News in 2022 that they hoped to enroll participants who reflect the demographic diversity of South Carolina, where just under 27% of residents identify as Black or African American. To date, though, they've failed to hit that mark. Only about 12% of the project's participants who provided sociodemographic data identify as Black, while an additional 5% have identified as belonging to another racial minority group.

“We'd like to be a lot more diverse,” acknowledged Daniel Judge, principal investigator for the study and a cardiovascular genetics specialist at the Medical University of South Carolina.

Lack of diversity in genetics research has real health care implications. Since the completion more than 20 years ago of the Human Genome Project, which mapped most human genes for the first time, close to 90% of genomics studies have been conducted using DNA from participants of European descent, research shows. And while human beings of all races and ancestries are more than 99% genetically identical, even small differences in genes can spell big differences in health outcomes.

“Precision medicine” is a term used to describe how genetics can improve the way diseases are diagnosed and treated by considering a person's DNA, environment, and lifestyle. But if this emerging field of health care is based on research involving mostly white people, “it could lead to mistakes, unknowingly,” said Misa Graff, an associate professor in epidemiology at the University of North Carolina and a genetics researcher.

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In fact, that's already . In 2016, for example, research found that some Black patients had been misdiagnosed with a potentially fatal heart condition because they'd tested positive for a genetic variant thought to be harmful. That variant is much more common among Black Americans than white Americans, the research found, and is considered likely harmless among Black people. Misclassifications can be avoided if “even modest numbers of people from diverse populations are included in sequence databases,” the authors wrote.

The genetics research project in Charleston requires participants to complete an online consent form and submit a saliva sample, either in person at a designated lab or collection or by mail. They are not paid to participate, but they do receive a report outlining their DNA results. Those who test positive for a genetic marker linked to cancer or high cholesterol are offered a virtual appointment with a genetics counselor free of charge.

Some research projects require more time from their volunteers, which can skew the pool of participants, Graff said, because not everyone has the luxury of free time. “We need to be even more creative in how we obtain people to help contribute to studies,” she said.

Moultrie said he recently asked project leaders to reach out to African American outlets throughout the Palmetto State to explain how the genetics research project works and to encourage Black people to participate. He also suggested that when researchers talk to Black community leaders, such as church pastors, they ought to persuade those leaders to enroll in the study instead of simply passing the message along to their congregations.

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“We have new ideas. We have ways we can do this,” Moultrie said. “We'll get there.”

Other ongoing efforts are already improving diversity in genetics research. At the National Institutes of Health, a program called “All of Us” aims to analyze the DNA of more than 1 million people across the country to build a diverse health database. So far, that program has enrolled more than 790,000 participants. Of these, more than 560,000 have provided DNA samples and about 45% identify as being part of a racial or ethnic minority group.

“Diversity is so important,” said Karriem Watson, chief engagement officer for the All of Us research program. “When you think about groups that carry the greatest burden of disease, we know that those groups are often from minoritized populations.”

Diverse participation in All of Us hasn't come about by . NIH researchers strategically partnered with community health centers, faith-based groups, and Black fraternities and sororities to recruit people who have been historically underrepresented in biomedical research.

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In South Carolina, for example, the NIH works with Cooperative Health, a network of federally qualified health centers near the state capital that serve many patients who are uninsured and Black, to recruit patients for All of Us. Eric Schlueter, chief medical officer of Cooperative Health, said the partnership works because their patients trust them.

“We have a strong history of being integrated into the community. Many of our employees grew up and still live in the same communities that we serve,” Schlueter said. “That is what is part of our secret sauce.”

So far, Cooperative Health has enrolled almost 3,000 people in the research program, about 70% of whom are Black.

“Our patients are just like other patients,” Schlueter said. “They want to be able to an opportunity for their children and their children's children to have better health, and they realize this is an opportunity to do that.”

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Theoretically, researchers at the NIH and the Medical University of South Carolina may be trying to recruit some of the same people for their separate genetics studies, although nothing would prevent a patient from participating in both efforts.

The researchers in Charleston acknowledge they still have work to do. To date, In Our DNA SC has recruited about half of the 100,000 people it hopes for, and of those, about three-quarters have submitted DNA samples.

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Caitlin Allen, a program investigator and a public health researcher at the medical university, acknowledged that some of the program's tactics haven't succeeded in recruiting many Black participants.

For example, some patients scheduled to see providers at the Medical University of South Carolina receive an electronic message through their patient portal before an appointment, which includes information about participating in the research project. But studies show that racial and ethnic minorities are less likely to engage with their electronic health than white patients, Allen said.

“We see low uptake” with that strategy, she said, because many of the people researchers are trying to engage likely aren't receiving the message.

The study involves four research coordinators trained to take DNA samples, but there's a limit to how many people they can talk to face-to-face. “We're not necessarily able to go into every single room,” Allen said.

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That said, in-person community seem to work well for enrolling diverse participants. In March, In Our DNA SC research coordinators collected more than 30 DNA samples at a bicentennial event in Orangeburg, South Carolina, where more than 60% of residents identify as Black. Between the first and second year of the research project, Allen said, In Our DNA SC doubled the number of these community events that research coordinators attended.

“I would love to see it ramp up even more,” she said.

——————————
By: Lauren Sausser
Title: Genetics Studies Have a Diversity Problem That Researchers Struggle To Fix
Sourced From: kffhealthnews.org/news/article/genetics-research-diversity-conundrum-black-participation-south-carolina/
Published Date: Thu, 25 Apr 2024 09:00:00 +0000

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