They stated that during the 6th International Congress on Health Tourism, a private investment breakfast will be held in conjunction with the financial sector. New ventures in this booming niche market will be presented, providing the country with thousands of jobs and innovative medical technologies and services.

Cambiaso said that the congress will be held on November 1 and 2 of this year at the JW Marriott Hotel in Santo Domingo and will feature multiple innovations and business opportunities, highlighting, above all, the talent of the Dominican medical class and its achievements, according to the program Esta Noche Mariasela.

Amelia Reyes Mora said the event will be a meeting point for multi-sector leaders. The country will be projected as a health and investment destination, promoting international accreditations and the projection of Dominican medicine.

It is noted that the DR is the leading destination for medical tourism in the Caribbean, number 2 in Latin America, and number 19 in the world, according to the Medical Tourism Index.

(CMC) – The Trinidad-based Caribbean Public Health Agency (CARPHA) says regional countries need to take adequate steps to prevent the trans-boundary spread of infectious diseases, describing it as a threat to regional and global health security.

CARPHA held a two-day conference in Trinidad and Tobago last week to discuss the devastating impact of the COVID-19 pandemic and other public health concerns, reiterating the necessity for regional and global health security to protect and improve health.

It said that Regional Health Security (RHS) encompasses the capacities required for the Caribbean to prepare for and respond to public health threats, risks, priority issues and concerns that transcend national boundaries and potentially impact on economic stability, trade, tourism, and access to goods and services in the region.

“RHS offers a coordinated approach which is especially crucial in the Caribbean as the region, like the Pacific and African small island developing states, is characterised by small, under-resourced populations and varying surveillance, laboratory and human resource capacities,” CARPHA said.

“It is also highly interconnected with porous borders, heavily reliant on tourism, and susceptible to climate change and disasters.”

The agency noted that this combination of factors significantly increases the region’s exposure and vulnerability to disease spread, enabling rapid spread of highly transmissible communicable diseases.

Furthermore, the tropical climate, and abundance of competent vectors make the region particularly vulnerable to vector-borne disease outbreaks.

“Consequently, regional health security and prevention, preparedness and response to public health emergencies need to be improved not only at the national levels, but at the regional level, as functional regional capacities are greater than the sum of the capacities of individual countries for improving RHS in the Caribbean,” CARPHA said.

“The major outcomes of this meeting include the detailing and prioritisation of member states’ current needs, increased awareness of CARPHA’s integrated surveillance and capacity building work and strengthening partnerships. These elements will assist in developing the sustainable RHS Pathway in short order.”

The post Region urged to prevent trans-border spread of infectious diseases appeared first on Barbados Today.

Efficient
pre-hospital care plays a critical role in saving the lives of people experiencing medical emergencies.

In cardiac and respiratory emergencies, the focus is on performing early cardiopulmonary resuscitation (CPR), defibrillation, in field diagnostics (ECG telemetry), initiation of treatment (aspirin, nitrates) as per protocol, and rapid transport to hospitals with capabilities of treating with cardiac emergencies.

The above-mentioned are the ideal scenarios, but in resource-challenged environments such as ours, these ideals remain only aspirational.

The chain of survival is a conceptual framework in the Emergency Cardiac Care community that outlines a series of six vital steps that are necessary to maximise a person's chances of survival during cardiac arrest.

Let us assess the readiness of Jamaica to provide the chain of survival for victims of cardiac arrest.

Link 1. Activation of the emergency response

Early recognition and activation of the prehospital emergency response is the first link in the chain of survival. Currently there is limited public awareness about recognising cardiac arrest symptoms. As a result, delays in seeking medical help are very common, thus hampering the effectiveness of this link.

Link 2. High-quality CPR

The immediate initiation of bystander CPR is essential for the success of any emergency medical response for cardiac arrest. In Jamaica, bystander CPR rates are dismally low due to limited knowledge and training among the general population. Reluctance to perform CPR may also be influenced by cultural factors and the fear of doing harm.

Over the past two decades the Heart Foundation of Jamaica has been an advocate for layperson CPR training as well as providing training for both prehospital and in-hospital medical responders. However, greater efforts are required to educate citizens about performing CPR, and to dispel the fears of people who may be willing to learn.

Link 3. Early defibrillation

This link speaks to the early use of automated external defibrillators (AEDs) on patients who are in cardiac arrest. It is used to deliver a "shock' to the patient. This is the only treatment for patients who are in cardiac arrest due to the lethal cardiac rhythms of ventricular fibrillation or ventricular tachycardia.

The availability of AEDs in public spaces is very limited. This may be due to two factors — cost and absence of legislation. The need for public access defibrillation is a cornerstone of the thrust to strengthen the chain of survival.

Link 4. Early advanced care

Prehospital Emergency Medical Care in Jamaica currently has two operational systems. There is a formal Ministry of Health and Wellness (MOHW)/Ministry of Local Government and Community Development (MLG & CD) emergency medical service. This service is manned by emergency medical technicians (EMTs), from the fire brigade-trained to the basic EMT level. This emergency medical service (EMS) operates in the parishes of Westmoreland, St James, Trelawny, and St Catherine.

The other system is that of private EMS operators. These private services operate in all parishes and provide a greatly needed service, although, operationally, they are largely unregulated. Great strides have been made over the years in training emergency room staff in basic and advanced life support, but there are still resource issues in our emergency rooms, which mitigate against offering patients the full level of care that is routinely available in places with more resources.

Link 5. Integrated post-cardiac arrest care

All patients who have achieved return of spontaneous circulation (ROSC) require admission to an intensive care unit (ICU). This high level of care is required because the underlying cause of the cardiac arrest often still exists, and the patient is at great risk of going back into cardiac arrest. The Jamaican reality is that there are simply not enough ICU beds available for the population.

Link 6. Recovery

The sixth link is recovery. It focuses on the need for continued treatment and rehabilitation of cardiac arrest survivors. It also focuses on the families and caregivers of the survivors.

Critical concepts for recovery include:

• Comprehensive post-cardiac arrest discharge planning for survivors and their families and caregivers. This includes medical follow-up and rehabilitative treatment. Advice on return to activity and work and management of these expectations.

• Assessment and treatment of the cardiopulmonary, neurologic, and cognitive impairments that often affect cardiac arrest survivors.

• Assessment and treatment of the many psychiatric ailments which beset near-death experiences. These include anxiety, depression, post-traumatic stress, and chronic fatigue.

Unfortunately, there is little or no focus on this very important sixth link.

Recommendations

To enhance Jamaica's readiness in providing the chain of survival, the following strategies are suggested.

1. Initiate State-funded public education programmes about recognising the symptoms of cardiac arrest and the steps in performing CPR

2. Create cardiac-ready communities. This involves the establishment of communities that meet the criteria for having:

*Laypersons trained in CPR. Free CPR training to communities empowers the citizens to provide immediate help in emergencies.

*Public access to AEDs. Increasing the availability and deployment of AEDs in public spaces, workplaces, and transportation centres can decrease the time to defibrillation.

*Blood pressure, cholesterol, and diabetic screenings. Identifies groups at higher risk of cardiac arrest. Allows for intervention.

*A functional EMS. Ensures timely and effective prehospital care and transport.

*Investment in road infrastructure. Improving road networks and addressing traffic congestion can facilitate faster EMS response.

*A properly equipped and staffed emergency room in the local hospital.

While Jamaica has invested in its health-care professionals with an emphasis on training and the existence of public and private EMS, there are significant challenges that impede its readiness to provide all the links in the chain of survival. A chain is as strong as its weakest link; therefore, the thrust must be to strengthen all the links.

By addressing the recognised issues of public awareness, CPR training, AED availability, and resource allocation, Jamaica can strengthen its pre-hospital, in-hospital, and post-hospital care, and contribute to a more robust chain of survival.

CPR week is being observed in Jamaica from August 21-24.

Dr Hugh Wong DM (Emergency Medicine) is the director of emergency cardiac care at the Heart Foundation of Jamaica. He can be contacted at hmarkwong@gmail.com

The meeting, led by the Pan American Health Organization (PAHO), comes as some countries in the region face large-scale outbreaks of dengue and intense circulation of chikungunya.

Members, which are made up of 35 national laboratories from across the region, technical advisors, and World Health Organisation (WHO) collaborating centres, will review ways to expand genomic and entomovirological surveillance to major arboviruses.

"At least nine arboviruses with public health impact — such as dengue, zika, chikungunya, and yellow fever — are circulating in Latin America and the Caribbean, so strengthening and expanding laboratory detection and surveillance capacities are key to ensuring a timely response to outbreaks and epidemics," Sylvain Aldighieri, deputy director of PAHO's Department of Health Emergencies, said.

Arboviruses are transmitted by the bite of arthropods (mosquitoes and ticks, among others). From the beginning of 2023 until the end of July, more than 3 million new dengue infections and more than 324,000 cases of chikungunya were reported in the Americas. With 27,000 cases across the region in the same period, Zika has a lower incidence rate, while sporadic cases of yellow fever represent a permanent risk of re-emergence of this potentially lethal disease.

"The epidemiological picture of arboviruses in the region is highly complex due to the epidemic potential of these diseases," José Luis San Martín, PAHO regional advisor on arboviral diseases, warned. "We must carry out an integrated prevention and control strategy that uses new innovations to closely monitor these viruses in laboratories," he added.

During the COVID-19 pandemic, genomic surveillance of SARS-CoV-2 proved key to understanding the virus, its variants, and advising public policy to prevent and control of the disease.

In the past years, investment and international cooperation have strengthened Arbovirus Diagnosis Laboratory Network of the Americas (RELDA) laboratories, and now at least eight countries in the region have introduced genomic sequencing within the framework of PAHO's Regional Strategy for Genomic Surveillance.

Many countries are taking advantage of these capacities and have started sequencing dengue, yellow fever, chikungunya, and other viruses, some for the first time. With RELDA's support, laboratories can expand this surveillance to find out the genomes of arboviruses circulating in their territory, their dispersion patterns, and analyse whether mutations are associated with greater transmissibility or severity.

For María Alejandra Morales, director of the PAHO/WHO Collaborating Centre on Viral Haemorrhagic Fevers and Arboviruses, National Institute of Human Viral Diseases (INEVH) in Argentina, "RELDA has a key role to play in the strengthening, growth, and continuous improvement of the laboratory component as part of an integrated management strategy for arboviruses."

Morales, who is currently the RELDA coordinator, also believes the expanded work of the laboratories with virological, serological, and molecular tests "will make it possible to generate timely and quality information for decision-making that can contribute to the prevention and control of arboviruses".

During the meeting, experts also discussed the status of entomovirological surveillance in the region, that is, the detection of viruses in mosquitoes before they reach humans. This type of surveillance, already conducted in some countries, can serve as an early warning system to anticipate arbovirus outbreaks or epidemics and allow for a more timely response.

PAHO began promoting entomovirological surveillance in 2017 and created the Entomo-Virological Laboratory Network (RELEVA), which currently includes laboratories in 14 countries. At the meeting, guidelines for this surveillance were presented and discussed. Laboratories in the network are also working on a plan for their implementation and plan to create a comprehensive arbovirus surveillance platform that includes mosquito surveillance data.

RELDA, which celebrates its 15th anniversary this year, is composed of 40 laboratories, technical advisors, and WHO collaborating centres, and is the operational arm of the laboratory component of PAHO's Integrated Management Strategy for Arboviral Disease Prevention and Control (known as IMS-arbovirus). Its main objective is to ensure efficient laboratory surveillance and a robust installed capacity to respond to arbovirus outbreaks and epidemics.

View the full post Minister actions on housing conditions in Mangrove, Carriacou on NOW Grenada.

Santo Domingo.- Santiago Hazim, the Executive Director of the National Health Insurance (Senasa), has confidently declared that the Dominican Republic boasts the most outstanding healthcare system across Latin America and even extends its influence into parts of North America.

This assertion is firmly grounded in the nation’s achievement of universalizing its healthcare system. Notably, the country’s coverage encompasses expenses up to two million pesos for an array of ailments, treatments, and essential medical procedures.

In a recent interview on the Despierta program with CDN, Hazim bolstered his claim by highlighting the extraordinary scope provided by the Dominican health system. He emphasized that this coverage extends to high-cost illnesses like cancer, organ transplants, chemotherapy, intricate surgeries, and neurosurgery.

Furthermore, this comprehensive coverage has yielded tranquility for patients, assuring them protection against various medical conditions, encompassing dialysis and other pathologies. This level of security, Hazim emphasized, is even absent in the United States.

Hazim contrasted the Dominican and American healthcare systems, revealing that in the United States, patients often grapple with substantial hurdles involving costs and prolonged waiting periods for medical care. Conversely, the Dominican health system ensures prompt and accessible care.

Dr. Hazim acknowledged that despite these commendable strides, the Dominican healthcare system still contends with deficiencies. Specifically, he mentioned the need to enhance imaging capabilities, such as X-ray equipment, 3D CT scans, and MRIs. He attributed these shortcomings to a cultural inclination and proximity to the United States, which fosters familiarity with cutting-edge medical technologies and advancements.

He further illustrated the situation, stating that the capacity for expanded coverage requires deliberation. Senasa, for instance, cannot unilaterally decide to cover laparoscopic surgery; an actuarial study by Sisalril (Superintendence of Health and Occupational Risks) is imperative to ascertain the frequency of such surgeries in the country, their costs at different facilities, and subsequently determine an average allocation for each ARS.

In closing, Hazim underlined the paramount importance of upholding the stability of social security and the healthcare system within the nation.

America’s pharmaceutical giants are suing this summer to block the federal government’s first effort at drug price regulation.

Last year’s Inflation Reduction Act included what on its face seems a modest proposal: The federal government would for the first time be empowered to negotiate prices Medicare pays for drugs — but only for 10 very expensive medicines beginning in 2026 (an additional 15 in 2027 and 2028, with more added in later years). Another provision would require manufacturers to pay rebates to Medicare for drug prices that increased faster than inflation.

Those provisions alone could reduce the federal deficit by $237 billion over 10 years, the Congressional Budget Office has calculated. That enormous savings would come from tamping down drug prices, which are costing an average of 3.44 times — sometimes 10 times — what the same brand-name drugs cost in other developed countries, where governments already negotiate prices.

These small steps were an attempt to rein in the only significant type of Medicare health spending — the cost of prescription drugs — that has not been controlled or limited by the government. But they were a call to arms for the pharmaceutical industry in a battle it assumed it had won: When Congress passed the Medicare prescription drug coverage benefit (Part D) in 2003, intense industry lobbying resulted in a last-minute insertion prohibiting Medicare from negotiating those prices.

Without any guardrails, prices for some existing drugs have soared, even as they have fallen sharply in other countries. New drugs — some with minimal benefit — have enormous price tags, buttressed by lobbying and marketing.

AZT, the first drug to successfully treat HIV/AIDS, was labeled “the most expensive drug in history” in the late 1980s. Its $8,000-a-year cost was derided as “inhuman” in a New York Times op-ed. Now, scores of drugs, many with much less benefit, cost more than $50,000 a year. Ten drugs, mostly used to treat rare diseases, cost over $700,000 annually.

Pharmaceutical manufacturers say high U.S. prices support research and development and point out that Americans tend to get new treatments first. But recent research has shown that the price of a drug is related neither to the amount of research and development required to bring it to market nor its therapeutic value.

And selling drugs first in the U.S. is a good business strategy. By introducing a drug in a developed country with limited scrutiny on price, manufacturers can set the bar high for negotiating with other nations.

Here are just a few of the many examples of drug pricing practices that have driven consumers to demand change.

Exhibit A is Humira, the best-selling drug in history, earning AbbVie $200 billion over two decades. Effective in the treatment of various autoimmune diseases, its core patent — the one on the biologic itself — expired in 2016. But for business purposes, the “controlling patent,” the last to expire, is far more important since it allows an ongoing monopoly.

AbbVie blanketed Humira with 165 peripheral patents, covering things like a manufacturing step or slightly new formulation, creating a so-called patent thicket, making it challenging for generics makers to make lower-cost copycats. (When they threatened to do so, AbbVie often offered them valuable deals not to enter the market.) Meanwhile, it continued to raise the price of the drug, most recently to $88,000 a year. This year, Humira-like generics (called biosimilars for its type of molecule) are entering the U.S. market; they have been available for a fraction of the price in Europe for five years.

Or take Revlimid, a drug by Celgene (now part of Bristol Myers Squibb), which treats multiple myeloma. It won FDA approval to treat that previously deadly disease in 2006 at about $4,500 a month; today it retails at triple that. Why? The company’s CEO explained price hikes were simply a “legitimate opportunity” to improve financial “performance.”

Since it must be taken for life to keep that cancer in check, patients who want to live (or their insurers) have had no choice but to pay. Though Revlimid’s patent protection ran out in 2022, Celgene avoided meaningful price-cutting competition by offering generic competitors “volume-limited licenses” to its patents so long as they agreed to initially produce a small share of the drug’s $12 billion monopoly market.

Par Pharmaceutical, another drugmaker, maneuvered to create a blockbuster market out of a centuries-old drug, isoproterenol, through a well-meaning FDA program that gave companies a three-year monopoly in exchange for performing formal testing on drugs in use before the agency was formed.

During those three years, Par wrapped its branded product, Vasostrict, used to maintain blood pressure in critically ill patients, with patents — including one on the compound’s pH level — extending its monopoly eight additional years. Par raised the price by 5,400% between 2010 and 2020. When the covid-19 pandemic filled intensive care units with severely ill patients, that hike cost Americans $600 million to $900 million in the first year.

And then there is AZT and its successors, which offer a full life to HIV-positive people. Pills today contain a combination of two or three medicines, the vast majority including one similar to AZT, tenofovir, made by Gilead Sciences. The individual medicines are old, off-patent. Why then do these combination pills, taken for life, sometimes cost $4,000 monthly?

It’s partly because many manufacturers of the combination pills have agreements with Gilead that they will use its expensive branded version of tenofovir in exchange for various business favors. Peter Staley, an activist with HIV, has been spearheading a class-action suit against Gilead, alleging “collusion.” The negotiated price for these pills is hundreds of dollars a month in the United Kingdom, not the thousands charged in the U.S.

Faced with such tactics, 8 in 10 Americans now support drug price negotiation, giving Congress and the Biden administration the impetus to act and to resist Big Pharma’s legal challenges, which many legal experts view as a desperate attempt to stave off the inevitable.

“I don’t think they have a good legal case,” said Aaron Kesselheim, who studies drug pricing at Harvard Medical School. “But it can delay things if they can find a judge to issue an injunction.” And even a year’s delay could translate into big money.

Yes, American patients are lucky to have first access to innovative drugs. And, sadly, patients in countries that refuse to pay up once in a while go without the latest treatment. But more sadly, polling shows, large numbers of Americans are forgoing prescribed medicines because they can’t afford them.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

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

A divided three-judge federal appeals court panel has ruled that a lower court was wrong to try to reverse entirely the FDA’s approval of the abortion drug mifepristone. The panel did find, however, that the agency violated regulatory rules in making the drug more easily available and that those rules should be rolled back. In practice, nothing changes immediately, because the Supreme Court has blocked the lower court’s order that the drug effectively be removed from the U.S. market — for now.

The case is pivotal for the future of reproductive health, as the pill is part of a regimen that is now the most common way American women terminate early pregnancies and is also widely used by doctors to manage miscarriages.

Meanwhile, as President Joe Biden’s Inflation Reduction Act turns one, Medicare officials are preparing to unveil which 10 drugs will be the first to face price negotiation under the new law.

This week’s panelists are Julie Rovner of KFF Health News, Shefali Luthra of The 19th, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.

Panelists

Shefali Luthra
The 19th

@shefalil

Read Shefali's stories

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Among the takeaways from this week’s episode:

• Wednesday’s federal appeals court decision siding with conservative medical groups challenging mifepristone regulations has perhaps the biggest implications for the drug’s distribution via telemedicine, which has been key to securing abortion access for people in areas where abortion is unavailable.
• The ongoing legal threat to mifepristone is reverberating through the drug industry, as drugmakers worry challenges to the FDA’s scientific authority could cause serious problems for future drug development — especially in an industry that takes big financial risks on getting products approved.
• Texas is suing Planned Parenthood over past Medicaid payments made to the program, charging that the health organization “defrauded” the state, even though the claims were made while a court had specifically allowed Planned Parenthood to remain in the program. Still, the lawsuit emphasizes just how far Texas has gone, and will go, to maintain the legal authority to not support Planned Parenthood, even in its non-abortion work.
• The federal government is expected to release the list of 10 pharmaceuticals subject to Medicare price negotiations by Sept. 1. The drugs’ identities are the subject of much educated speculation, as Congress laid out in the law how drugs qualify for consideration — though even stakeholders in the drug industry are wondering which specific drugs will be up for discussion.
• A national survey of pharmacists finds drug shortages are widespread and leading to rationing at the pharmacy level. A lack of incentives to produce generic drugs is complicating supply-chain problems, leaving fewer options when there are manufacturing or other types of issues with a particular drugmaker.

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

Julie Rovner: Time’s “She Wasn’t Able to Get an Abortion. Now She’s a Mom. Soon She’ll Start 7th Grade,” by Charlotte Alter.

Sarah Karlin-Smith: MIT Technology Review’s “Microplastics Are Everywhere. What Does That Mean for Our Immune Systems”? by Jessica Hamzelou.

Shefali Luthra: The Atlantic’s “Right Price, Wrong Politics,” by Annie Lowrey.

Alice Miranda Ollstein: Politico’s “We’re on the Cusp of Another Psychedelic Era. But This Time Washington Is Along for the Ride,” by Erin Schumaker and Katherine Ellen Foley.

Also mentioned in this week’s episode:

• States Newsroom/The Georgia Recorder’s “Study Cited by Texas Judge in Abortion-Pill Case Under Investigation,” by Sofia Resnick.
• Stat’s “From Drug Shortages to High Prices, U.S. System’s Shortcomings Have Deep Roots,” by Matthew Herper.

Click to open the transcript

Transcript: Abortion Pill’s Legal Limbo Continues

KFF Health News’ ‘What the Health?’

Episode Title: Abortion Pill’s Legal Limbo Continues

Episode Number: 310

Published: Aug. 17, 2023

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Aug. 17, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: So, no interview this week but plenty of news, particularly for the middle of August, so we will get right to it. The breaking news this week is about abortion and about a Texas abortion case, because 2023. Technically, this news is out of New Orleans, where on Wednesday a three-judge panel of the 5th Circuit federal Court of Appeals upheld, in part, a lower-court decision from Texas that found that the FDA was wrong to approve the abortion pill mifepristone back in the year 2000. Before we get any further in this discussion, we should point out that this decision does not impact the immediate availability of abortion pills. The Supreme Court earlier this spring issued a stay of the lower-court ruling, meaning nothing will change until the full outcome of the case is determined, presumably by the Supreme Court at some point, probably next year. But, Alice, remind us of what this case was about and then what the decision means.

Ollstein: Yeah. So this case is: A coalition of different anti-abortion medical groups that formed last year, specifically formed in the district that a very conservative judge was in charge of down in Texas, brought the case there. And they are going after both the original FDA approval of mifepristone more than two decades ago and a bunch of decisions the agency has made since then to make the pills easier for patients to obtain, like allowing mail delivery, like allowing their use longer into pregnancy than before — 10 weeks versus seven weeks — allowing nonphysicians to prescribe the pills, a bunch of different things.

Rovner: And allowing for a lower dose of the pill actually.

Ollstein: Yes, yes.

Rovner: Which is going to get significant in a second. Go ahead.

Ollstein: Definitely. We should talk about the labeling chaos that could result from this. But so basically, the lower-court judge went all in, agreed with everything they said, essentially, and more or less ordered a national ban. That got stayed. It remains stayed for now, but the 5th Circuit has now weighed in and endorsed some but not all of those arguments. They said, look, the statute of limitations has passed us by on challenging the original FDA approval of the drugs, but they sided with the groups in ordering FDA to get rid of all of those other subsequent decisions. And so this, if upheld by the Supreme Court — we know the Biden administration is already planning to appeal — would really put the pills out of reach for a lot of people. So, it would be a sharp curtailment, but not the total ban the groups were seeking.

Rovner: Yeah, Shefali, and this was obviously what the appeals court had been leaning towards anyway. We know that because that was what they had done before the Supreme Court overruled it. And certainly we know that Justice [Samuel] Alito and I believe Justice [Clarence] Thomas would also do this. So, there’s every reason to believe that this could well be the final outcome. What would it mean? So, the pill would still be approved, but only in the form it was allowed to be distributed before 2016?

Luthra: Precisely, which would be quite significant. You mentioned, right, the need to relabel pills based on the different formulation. We would have pills technically only approved up until seven weeks of pregnancy, although doctors could prescribe them off-label, through 12 weeks in all likelihood. But the telemedicine implications are probably some of the biggest, especially in states where they’ve seen large numbers of out-of-state patients coming for abortion care, right, because they’re near states with bans. Those clinics have really relied on telemedicine because it means they can see more people, and it’s quite safe, right? It’s endorsed by the World Health Organization. You don’t need someone to come in for two, in some cases three visits to get a couple of pills and take them at home. And to lose that would really just cut capacity and make abortions, which are already very difficult to obtain, even in states where it’s legal but there just aren’t as many clinics — like a Kansas, a New Mexico, etc. — if not impossible, very nearly so, just because the math doesn’t work in terms of providers versus patients in need.

Rovner: And the piece of this that I really don’t understand, and I read through the entire decision yesterday afternoon, was they said that the plaintiffs in the case cannot challenge the approval of the generic version of the drug, which was approved in 2019. But of course, the generic version of the drug was approved under the then-rules that that are now going to be rolled back. So you would — would you have a case for the brand name and the generic would have different labeling requirements? It seems very confusing.

Luthra: I think there are a lot of questions that are still open about what this means, right, not only for mifepristone but just for the precedents of FDA approval of medications at large, especially as we’ve seen so many more FDA-approved drugs become more politicized. And, I mean, that’s one of the reasons that so many medical groups have expressed deep concern about this case. It just opens a tremendous can of worms looking well beyond abortion and puts us in pretty uncharted territory for what comes next.

Rovner: And the drug industry is kind of freaked out. Sarah, I guess you could talk to this. I mean, the reliability of FDA approval is now called into question if anybody can basically go to court and say, “Nope, FDA, you shouldn’t have done that,” and possibly win, right?

Karlin-Smith: Right. I mean, they don’t want the scientific sort of authority of the FDA questioned. And I think, you know, like a lot of hot-button political issues where there’s maybe not a good side for them to be on, the pharmaceutical companies tend to try and stay out of abortion politics as much as they can. But some executives and so forth did join amicus briefs in this case because they are concerned about the precedent of FDA approval decisions being able to be challenged in court. And if nothing else, I think drug companies really, and any business to an extent, relies on, like, certainty. And so just having the loss of that certainty that an FDA decision really means, what it means is problematic for them. But I think also these are companies that sort of are based in science and medicine and would definitely prefer to have the assurance that those are the people that approved their drugs and kind of give that seal of approval and it means what it says.

Rovner: Yeah, and the drug industry, I think more than many others, which depends on long shots a lot. I mean, there’s just a lot of dry holes in the drug industry; you spent a lot of time and a lot of money on a drug that ends up not going anywhere. So if you spend a lot of time and a lot of money on a drug that does what it’s supposed to do and gets approved, I think that that could certainly dampen the enthusiasm if then a court could come and say, “Oops, nope.”

Karlin-Smith: And the reputation we talk a lot about, like drug pricing, on this show — the reputation of the FDA and the perceived quality and trustworthiness of its decisions is kind of why the drug companies can charge, to some degree, the prices they charge for their medicines versus, say, you know, we compare it to the supplement industry, which is very loosely regulated, and their claims are not really backed up in the same way by science and medicine. And you can buy those for much cheaper at the store. So their whole business model is really threatened by this.

Rovner: Yeah.

Ollstein: And I think it’s worth noting that one of the three judges on the panel wanted to go further and fully strip FDA approval from the drug, but he was overruled by his other two colleagues. But still, he wrote that dissenting opinion. And that could come into play if and when the Supreme Court takes this up.

Rovner: And he, of course, raised the specter of the Comstock Act, that 1800s-era anti-vice law that apparently some anti-abortion groups are hoping to sort of bring back into the 21st century — Are we in the 22nd century? I’m losing track — and try to figure out if you can just make all of this illegal.

Ollstein: Yes. Judge [James] Ho, who was appointed by [then-President Donald] Trump to the 5th Circuit, and his opinion went a lot further than his colleagues’ in embracing the arguments made by the challengers. So how much influence that has on the process going forward will be really interesting. You know, the Comstock Act has to do with things sent through the mail, and the concern from a lot of legal experts and medical groups is that the interpretation that Judge Ho and these groups are making could mean that sending anything that could potentially be used for an abortion, even if it’s medical equipment that’s also used for other things, could be in jeopardy. And this would be mail delivery. Even sending something to a state where abortion is protected by law could be challenged under this federal rule. And so, we’re definitely in a “throw things at the wall and see what sticks” kind of era. And this is one of the things they’re throwing at the wall.

Rovner: Yeah, just because nothing changes for now doesn’t mean that nothing is going to change. And we will obviously keep a very close eye on this. So last week we talked about a controversy surrounding one of the scientific studies that [District] Judge [Matthew] Kacsmaryk, the lower-court judge, relied on in his ruling. The study was by the Charlotte Lozier Institute. It found that women who had medical abortions were more likely to go to a hospital emergency room within 30 days than women who had surgical procedures. And we talked about how that paper is currently under review by the publisher of the journal the paper appeared in. During the discussion, I apparently misspoke about the paper’s findings, suggesting that it was just the raw number of ER visits that rose along with increased use of medication abortion rather than the rate of the visits. But nonetheless, this study is very much an outlier in three decades of research into the safety of the drug. And I say three decades because it was available in Europe many years before it was available in the United States. And the drug has otherwise been found to have very few serious complications, right?

Luthra: Right. I think you’re absolutely correct, Julie. The study remains an outlier. There remain serious methodological questions about how it came to its findings. And we have an incredibly rich body of research that continues to grow, that shows exactly what you said, which is that the complication rate for medication abortions remains incredibly low. Most people do not require follow-up medical care, especially not in an emergency room. And the reliance on that study in particular was quite striking because of what an outlier it is in the larger medical body of research.

Rovner: And it didn’t actually come up in the appeals court ruling, although they did say, and fair point, they acknowledged that the complication, the serious complication rate, is very low. But if it’s being used by a lot of people and we now know that medication abortion is more than half of all abortions, a very small percentage of a whole lot of people is still a fair number of people. Whether that is enough people to actually create the kind of havoc in emergency rooms that’s been suggested is a different question. But I think that the appeals court justices were fairly careful in the way they worded that. So the mifepristone ruling was not the only news this week about a Texas abortion case. Another Texas abortion case in front of Judge Kacsmaryk in fact: He held a hearing earlier this week in a case brought by the state of Texas to require Planned Parenthood to pay back more than a billion dollars in Medicaid reimbursements, not for abortions, but for family planning and other medical services covered by Medicaid. This one is a weird case even by Texas standards, right?

Ollstein: Yeah, and I’ll say that they’re suing them for more than a billion dollars, but they were only paid by Medicaid in the lower millions. You know, 17-ish million is what Planned Parenthood told me. So, the 1.8 billion is for penalties and damages. They’re accusing them of defrauding the state. So, there has been a many-years’ fight over Planned Parenthood’s participation in Medicaid in Texas specifically, also in other states. Planned Parenthood says that, you know, because lower courts for years blocked the state’s attempt to kick them out of Medicaid, they were perfectly allowed to continue providing nonabortion services, like contraception, tests, whatever, and be reimbursed for that. And the state coming back later and saying that they knowingly defrauded the Medicaid program, they see it as a political attack on them and their ability to keep providing services in the state.

Rovner: There was a court stay on Texas’ desire to kick them out of the Medicaid program, right, so at least at the time it was legal for them to bill Medicaid, and Texas paid the Medicaid claims that they billed, right?

Luthra: I think it’s also helpful to situate this in just a really long history of Texas doing whatever it can to get Planned Parenthood away from government dollars, including turning down millions in federal funding, starting their own state health program for reproductive health, just so that they could have the legal authority to not include Planned Parenthood. This is not really new, but it just is so striking because of the money at stake, because of sort of the tactics, and because of the implications in a world where Planned Parenthood isn’t even providing abortions in Texas anymore.

Rovner: This goes back probably before some of you guys were born, the efforts to sort of defund Planned Parenthood from state and federal dollars, even in states where Planned Parenthood never provided abortions. And there are a number of states where they never provided abortions. But there is a line in the Medicaid statute itself about free choice of providers for patients, and that’s what has been relied on. Lower courts have relied on that for years and years. Congress tried to change it and couldn’t. Texas is actually, I think, the first state that’s ever successfully gotten a court ruling that said they can cut Planned Parenthood out of their Medicaid program. So, it was not odd for Planned Parenthood, while this litigation was going on, to say, “We’re just going to continue to provide women who come to us with family planning and other health care services that we’ve been providing under Medicaid for generations.” But now we’ll see what Judge Kacsmaryk has to say. And then I imagine this will get appealed and we will see where this one ends up, too. Well, finally this week in reproductive health, the American College of Obstetricians and Gynecologists announced the introduction of an online abortion training program, which has been a year in the making, that will give all OB-GYN residents, even in states with abortion bans, access to at least the basics in abortion care and in caring for early pregnancy loss, which is all often the same care. But I have to wonder whether this is going to make students any more willing to do their residencies in states that effectively restrict the rights to practice medicine according to evidence-based standards. I know we’ve talked about this before, but we’re looking at what could be a serious shortage of just women’s reproductive health care in general in abortion ban states, right, if the supply of students wanting to go there to do their residencies and hence stay on afterwards is going to start to dry up?

Ollstein: I mean, it’s already happening for sure. Applications are going down in these ban states. And, you know, when I saw the online curriculum, that’s better than nothing. But all the medical students and residents I’ve spoken to really stress that, in order to be trained and, for some specialties, board-certified, you need practical experience; you need to personally participate in many, many, many abortions to be fully qualified as a physician. And they really stress that the more you do, the more different complications you’re able to observe. And if you only do a few or none and just do online curriculum, you’re not going to be really prepared for a miscarriage situation or any of the many things that could come up in the future. And these could be life-or-death moments. And so to not have people trained and ready to respond in certain states where it’s already hard to recruit people because of, you know, it’s just seen as a less desirable place to be, this is yet another factor. On top of that, you have state attorneys general who have been very litigious and threatening to providers. And so, I’m hearing that that fear is making people not want to practice in particular states.

Luthra: And I think another factor that we don’t often sort of say out loud, but that’s really relevant when it comes to OB-GYNs in training, is that the majority of OB-GYNs are women. And given the age of when people finish medical school, etc., many of them are pursuing residency when they’re at a stage in their life where they might consider getting pregnant, which means that the risks are not just professional or educational; in many cases they are quite personal, and that’s a factor that many people are considering as well.

Rovner: And even the male OB-GYNs in training, many of them are married to women and, again, same age, thinking about, it’s time to start a family. Also, it’s not just the residents themselves, but the residents’ families. I’ve seen that sort of from both sides. We should point out, I mean, there are training programs now and they’re obviously — you know, it’s only been a year, so it’s hard to sort of create these things out of whole cloth — but where residents can travel to other states to get some hands-on experience and training that they want. But again, one of the things we forget sometimes about residents is they don’t earn a lot of money and it’s a disruption. I mean, it’s hard enough to move to a place to do your residency; to then have to sort of pick up and move someplace else for a couple of months to do a rotation is not terribly convenient either. So this is obviously still all being sorted out. But the education of sort of the next generation of reproductive health providers is definitely under question here, right?

Ollstein: And it’s not just the time needed; it’s often the money, because if these people are doing their residency at a public university hospital in a ban state, that public university hospital, under the state law, is afraid to give any money to support them going to another state for training. And so often people either have to apply for grants from foundations to cover that expense or even pay out of their own pockets. So, it’s a real heavy lift.

Rovner: It is. Well, in other news, and there is other news this week, President [Joe] Biden is taking a victory lap as the Inflation Reduction Act, that omnibus health-slash-energy-slash-tax bill, turns 1. But the fate of the highest-profile health policy in that law, calling for Medicare to negotiate the prices of some very expensive drugs, is still in some doubt, as drugmakers sue to try to block the program. Sarah, where is this, and when do we expect to get that list of the first 10 drugs the government wants to negotiate the price of? That’s due soon, right?

Karlin-Smith: Right. So the list is due by Sept. 1 at the latest. So that is a week, I think, from this Friday, or no, a little bit longer than that. But the expectation, I think, is we may get it before Sept. 1, because that’s the Friday before Labor Day weekend.

Rovner: Oh, I don’t know. They love to drop stuff the Friday before Labor Day.

Karlin-Smith: Sometimes they do, and sometimes they also want to take a break too. So, we’re expecting that list of 10 drugs, which would be — their negotiated prices would go into effect in 2026. There’s lots of reasonably well-educated guesses of what those drugs are, because the law sort of lays out how they select them and we have a general sense of how much money is spent on certain drugs in the U.S. and so forth. But Medicare has the most up-to-date data. So, there are still companies that kind of have a sense of, “Oh, I might be on the edge,” depending on how their sales have been in Medicare the past few years. So, people are really curious.

Rovner: Coincidentally or not so coincidentally, I’ve seen some of the speculation, and it is all of the drugs that you see all of those ads for, if you watch, if you still watch, you know, commercial television, on the news or on cable TV. I mean, there are so many ads, and it’s like, surprise, these are all the drugs that are on the likely list that Medicare is going to want to do something about the price of. I assume that is not a coincidence. I’m being snide.

Karlin-Smith: I think some of it is, right, to qualify for the list, you have to be in sort of the top spending categories. And part of that means you’re most likely to have to treat large populations of people. So when you get to drugs like that, like anticoagulants — I think there’s a few expected to be up there — blood thinners, some anti-diabetic medicines, trying to think of some of the other examples. These are kind of mass-market drugs that a lot of people, particularly in the Medicare population, need these medicines. Some cancer medicines, anti-inflammatory drugs. So, it’s not particularly surprising that you would see advertisements for them. And in a lot of cases, too, these are drugs that have some amount of brand competition for them. So, there are two newer blood thinners that might be on there. So, you know, that tends to lead to advertisement when there’s competition in a space. Same for the diabetes medicines and the anti-inflammatories; there’s a lot of expensive biologics in that space that compete.

Rovner: Well, when I’m in charge of the FDA, they’re not going to be able to use, like, songs from the ’60s and ’70s anymore, because that just makes me crazy. Well, meanwhile, in something related to this, drug shortages seem to be getting worse. There’s a new survey from the American Society of Health-System Pharmacists that found that 99% of the 1,100 hospital pharmacists that responded said they were currently managing drug shortages, and one-third said those shortages are forcing them to ration, delay, or cancel treatment. And these aren’t minor drugs. They include cancer chemotherapies, anesthesia drugs, other things that can be difficult to get but important when you need them. Sarah, is this a manufacturing problem, or a marketing problem, or both? I mean, why are drug shortages so much worse now? It’s not all supply chain, is it?

Karlin-Smith: There’s some supply chain, and I think there’s still some supply chain issues that started during covid that are still impacting people. There are manufacturing concerns, depending on the company. You know, drug shortages have gotten a lot of attention recently, but really for probably the past decade or so that I’ve been covering the drug industry and following shortages, the reasons have tended to be the same: They tend to be older, sterile, injectable drugs that are harder to make. But yet, because they have gone generic, the prices have gone down so low that players tend to leave. So only a few players stay in the market because of the pricing situation. So then if they have any manufacturing problem, it can very easily lead to a shortage. Generic companies argue that, you know, there’s just not a lot of incentive for them to invest in redundancy or certain even manufacturing capabilities that might help prevent shortages. So, for better or worse, there really hasn’t been a lot of change in the reasons for these shortages over the years; it’s just that they keep happening.

Rovner: Yeah, well, it’s funny. Matthew Herper over at Stat News has kind of a provocative piece about all of this, suggesting, as you say, that the shortages right now are, in large part, due to the incentives to find the cheapest generics, but that this new Medicare negotiation process — which includes a different clock; it will be based on time on the market rather than time under patent — could encourage drugmakers to do the opposite thing, to sit on new drugs until they can test for all possible uses because they don’t want to bring them to market until they think they can make the most money, because that’s going to determine how long before there can be competition. I mean, is this ever really going to work, being a purely capitalist market?

Karlin-Smith: I mean, there are definitely people, you know, in the shortage space that have argued that some of the current shortages make a good case for public manufacturing of drugs. And actually, it might surprise some people, but the U.S. has engaged in the past in public manufacturing. There are some efforts going on now, like in California; they’re looking into some public manufacturing. So that’s on the generic side. On some of the other situations that Matthew Herper is describing with the IRA, it’s a bit more complicated because essentially the IRA does give companies some amount of time on the market without negotiation. But a lot of drugs, they have all these multiple indications. And so companies are just trying to figure out potentially how they can game their products to make the most amount of money before they’re subject to negotiation. And I know Medicare is quite aware of some of this stuff and is thinking about how they can set up their regulations to protect against that. But not everything is within their control. So we’ll see what happens, because there is concern, you know, particularly I think in the orphan or rare disease space, that a company may delay getting a rare disease indication based on when they think they might get subject to drug negotiations.

Rovner: Every time you think, Oh, they can just lower the price of drugs, it’s super, super complicated. All right. Well, finally this week, there’s something I’ve been trying to get to for a couple of weeks: Before Congress left for the August recess, it passed, on a bipartisan vote, a bill that could finally dethrone UNOS, the United Network for Organ Sharing. UNOS has been the outside organization handling the collection and distribution of human organs for transplant since the federal government began the federal transplant program in 1984. Over the years, UNOS has been roundly criticized for its handling, or mishandling, of the system. But the legislation that originally created the federal organ transplant program had been interpreted not to allow anyone else to compete for the contract to run the network. So, this legislation changes that, for the first time letting other entities see if they can do a better job so maybe fewer people will die waiting for transplanted organs. This feels a lot more important than the attention that it got, I think because there was so much else happening as Congress was leaving town. Or does it feel important to me because I spent so many years and so many hours watching Congress fight over this?

Karlin-Smith: I think it is important. There’s certainly been a lot of big exposés of problems in the system over the years. And there’s also been a lot of, when I’ve covered this more closely in the past, like, tensions between different parts of the country in sort of figuring out how organs are allocated and which parts of regions get impacted or not. So there has always been, like, political dynamics here. I think the underlying thing to watch with this overhaul is that part of what goes on here is we just don’t have enough organs for the number of people that need it. So, you can certainly make improvements and make sure that all the organs we have get to people and get done in the fairest way possible, because there have been lots of concerns around equity issues, particularly that Black people and other people of different ethnicities have not been, you know, getting the organs they deserve. But the question becomes, you know, can anybody do anything about a shortage of organs, and how do you really handle that? I think there’s always going to be tensions on this topic if you don’t have enough organs.

Rovner: Yeah, these were the ultimate formula fights, if you will. You know, it’s usually over money. In the ’90s and early 2000s, it was literally over organs, over, you know, how far you could ship donated organs and whether the large transplant centers should keep more because they do more organ transplants and therefore are more likely to have success. And boy, this fight has been going on for a very long time, but this is at least a step, I think, towards resolving it. All right. Well, that is this week’s news. We will take a quick break and then we will come back and do our extra credit. Hey, “What the Health?” listeners, you already know that few things in health care are ever simple. So, if you like our show, I recommend you also listen to “Tradeoffs,” a podcast that goes even deeper into our costly, complicated, and often counterintuitive health care system, hosted by longtime health care journalist and friend Dan Gorenstein. “Tradeoffs” digs into the evidence and research data behind health care policies and tells the stories of real people impacted by decisions made in C-suites, doctor’s offices, and even Congress. You can subscribe to “Tradeoffs” wherever you get your podcasts. OK, we are back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it; we will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Shefali, why don’t you go first this week?

Luthra: My piece is from The Atlantic, by Annie Lowrey. The headline is “Right Price, Wrong Politics.” It is incredibly smart. It is about how there is all this conversation about people wanting to move to states where they have access to health care protected, whether that is abortion or gender-affirming care, etc., etc. There is one problem, which is that those states are largely ones where it is much more expensive to live, because of housing prices. And if you want to live in a place where you can afford a home, those are often the states with restrictions on health care. I love this piece. I think there is so much conversation about, Why don’t people simply move to a place where state laws reflect what they would like? And the answer is it’s really not attainable for most people. And I think she does a great job of explaining why that is and putting it in the context of policy choices and not just sort of individual human elements.

Rovner: I was super jealous of this piece. It was like, Oh, yeah, of course. Alice.

Ollstein: I chose a piece by a couple of my colleagues, and it’s called “We’re on the Cusp of Another Psychedelic Era. But This Time Washington Is Along for the Ride.” And it’s about how much bipartisan support there is in Congress right now for making psychedelics more available as medicine to treat things like PTSD [post-traumatic stress disorder] or depression. There are just a lot more clinical trials going on right now and just support for making them available through the VA [Department of Veterans Affairs] as sort of a test of how a broader population might respond. You know, we’re talking about things like psilocybin, things like ketamine, things like ecstasy, that have shown a lot of promise in having a therapeutic benefit for mental health conditions that have resisted other forms of treatment. So, fascinating stuff.

Rovner: It is. Sarah.

Karlin-Smith: I took a look at a piece in MIT Tech Review called “Microplastics Are Everywhere. What Does That Mean for Our Immune Systems?” And it just does a good job of helping you understand what the research has shown about how these very tiny particles may impact your immune cells and then impact our ability to fight off diseases and maybe even lead to more challenges with antibiotics and antibiotic resistance. And I’ve been fascinated by all the coverage of this, because this — huge problem and, you know, they talk about them being in our air and in the deepest part of the ocean. And, you know, it’s just one of those things that we have to kind of grapple with as a society, like health, economic consequences, and so forth. So, it’s worth looking at.

Rovner: More things to keep us awake at night.

Karlin-Smith: Exactly.

Karlin-Smith: A list of more things to keep us awake at night. My story this week is one of the most talked about on social media. It’s from Time, and it’s called “She Wasn’t Able to Get an Abortion. Now She’s a Mom. Soon She’ll Start 7th Grade,” by Charlotte Alter. And as the headline indicates, it’s kind of a gutting piece about a 12-year-old in Mississippi who was raped in her own yard, was too scared to tell anyone, and ended up having a baby at age 13. It’s another story about all those things that are, quote, “made up,” or not supposed to happen. Except they did. She might have been eligible for a rape exception, except there are no abortion providers left in the state, and her mother didn’t know that rape exceptions were a possibility. In the end, the closest place for her to have gotten an abortion was Chicago, which was too far and too expensive for her family. So now she has a son while she’s going to middle school. I’m sure we will see more of these as time progresses. All right. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our amazing engineer, Francis Ying. And as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me or X me or whatever. I’m still there, @jrovner, also on Bluesky and Threads. Shefali?

Luthra: I’m @shefalil.

Rovner: Alice.

Ollstein: @AliceOllstein.

Rovner: Sarah.

Karlin-Smith: I’m @SarahKarlin or @sarahkarlin-smith.

Rovner: We will be back in your feed next week. Until then, be healthy.

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