Alexander, MD, FOMA, DABOM, DABLM, incoming president of the Obesity Medicine Association and chief medical officer of Enara Health, explained.She pointed out that 50% of patients with obesity can have nutritional deficiencies.

We may also hold a listening party, where the rotation may include this, this, this and this. And what about you? This is a lovely time of year to enjoy the great outdoors. Perhaps you can catch a view of some cherry blossom trees while there is still time. You could stroll city streets to take in the sights. Life is with people, as they say. Or you could hold your breath and spend time catching up on the news of the world. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Cigna plans to make copies of AbbVie’s Humira arthritis drug available with no out-of-pocket payment to eligible patients in the U.S. using its Accredo specialty pharmacy beginning in June, Reuters writes. Cigna said it will stock high- and low-concentration versions from Boehringer Ingelheim, Teva Pharmaceutical, and Alvotech, which will be priced at about 85% lower than the $6,922.62 monthly list price of Humira. Deals were made with the manufacturers as well as its distributor Quallent to bring the out-of-pocket cost down to $0. Cigna said the move should save around $3,500 on average per year for some of the 100,000 Accredo patients using either Humira or biosimilar.

The World Health Organization says new evidence shows the extensive overuse of antibiotics during the Covid-19 pandemic worldwide, which may have exacerbated “silent” spread of antimicrobial resistance. While only 8% of hospitalized patients with Covid-19 had bacterial co-infections requiring antibiotics, some 75% of patients have been treated with antibiotics “just in case” they help. Overall, antibiotic use did not improve clinical outcomes for patients with Covid-19. The highest rate of antibiotic use was seen among patients with severe or critical Covid-19, with a global average of 81%. In mild or moderate cases, there was a considerable variation across regions.

Continue to STAT+ to read the full story…

It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

“For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study. “The approval of EMBLAVEO is welcome news for the infectious disease community and provides new hope to critically ill patients affected by antimicrobial resistance.”

Antimicrobial resistance (AMR) – when bacteria, viruses, fungi, and parasites change and find ways to resist the effects of antimicrobial drugs – is recognized as one of the biggest threats to global health. If AMR continues to rise unchecked, minor infections could become life-threatening, and many routine medical procedures such as caesarean sections and hip replacements could become too risky to perform. Multidrug-resistant Gram-negative bacteria are of particular concern due to the high rates of morbidity and mortality they cause. Metallo-β-lactamases (MBLs) are a type of enzyme produced by certain bacteria that can result in resistance to antibiotics, and MBL-producing Gram-negative bacteria are on the rise globally. Developing new treatments for infections caused by Gram-negative bacteria has been prioritized by the World Health Organization (WHO) as a critical area of focus due to their increasing spread.

“The European Medicines Agency’s accelerated review of EMBLAVEO reflects the urgent need for new treatments to address the threat of antimicrobial resistance,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With this approval, Pfizer is proud to take another step forward in its commitment to developing and bringing breakthrough health solutions to patients impacted by serious infectious diseases around the world.”

This approval is based on results from the previously reported Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of EMBLAVEO in treating serious bacterial infections due to Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data support that EMBLAVEO is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.

The marketing authorization of EMBLAVEO is valid in all 27 European Union (EU) member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for EMBLAVEO are planned for submission in other countries.

EMBLAVEO combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor. MBLs are a class of β-lactamase enzymes that are not inhibited by current β-lactamase inhibitors and hydrolyze nearly all β-lactam antibiotics, with an exception being monobactams such as aztreonam. However, monobactams are degraded by other β-lactamases that are frequently co-produced with MBLs, limiting the clinical usefulness of aztreonam monotherapy.

The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that co-produce MBLs and other β-lactamases and provides a well-tolerated and effective treatment option against multidrug-resistant Gram-negative bacteria. These multidrug-resistant Gram-negative bacteria include MBL-producing Enterobacterales, which have been highlighted as a critical priority pathogen by the WHO, and S. maltophilia. EMBLAVEO is the β-lactam/β-lactamase inhibitor combination for treating serious bacterial infections in adult patients caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU.

EMBLAVEO was jointly developed with AbbVie. Pfizer holds the global rights to commercialize this therapy outside of the U.S. and Canada, where the rights are held by AbbVie. Development of EMBLAVEO was also supported by public-private partnerships between Pfizer and the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C; and through the EU’s Innovative Medicines Initiative(IMI) – a partnership between the EU and the European pharmaceutical industry – under a project called COMBACTE-CARE (Combatting Bacterial Resistance in Europe – Carbapenem Resistance). The COMBACTE-CARE consortium is a unique public-private collaboration that unites the knowledge and capabilities of leading drug-resistant bacterial infection experts and is supported by the COMBACTE pan-European clinical and laboratory networks.

Read also: Pfizer Gets CDSCO Panel Nod To study anti-cancer drug Lorlatinib

Second-line medications are those that are given when one or more of the drugs given first for the disease are not effective. The research could have implications for shortening the duration of treatment for drug-resistant TB, which currently requires medications for up to 2 years, while those with drug-sensitive TB complete treatment in about 6 months.

The study, published  in The Journal of Infectious Diseases, “is thought to be the first to address the knowledge gap surrounding the microbiological response of patients receiving these two therapies,” said the paper’s lead author Dr. Kayvan Zainabadi, assistant professor of molecular microbiology at Weill Cornell Medicine.

“We found that the new drugs we use to treat the drug-resistant form of the disease are as effective as our first-line medicines,” said study co-author Dr. Daniel W. Fitzgerald, director of the Center for Global Health at Weill Cornell Medicine. “Historically, they were much worse.”

Evolving Treatments for a Devastating Disease

Mycobacterium tuberculosis, the bacterium that causes TB, infects the lungs, causing cough, fever and often death. Worldwide, 10.6 million people developed the condition in 2022, resulting in about 1.3 million deaths, according to the World Health Organization (WHO), making it the top infectious disease killer worldwide. Approximately four percent of new TB infections are drug-resistant, which disproportionately contribute to 12 percent of deaths from the disease.

In 2012, the United States Food and Drug Administration approved bedaquiline, the first new TB drug in four decades, leading the WHO to update treatment guidelines for drug-resistant TB in 2018. The new guidelines allowed for bedaquiline, an oral drug, to replace the more toxic injectable antibiotics such as streptomycin. These new regimens are also much easier to implement in the resource-limited settings where TB is common. Together these factors improve the chances of patients completing treatment, which is important because not doing so results in more drug resistance, Dr. Zainabadi said.

Due to differing drug availabilities across the world, there is no single standard bedaquiline-based second-line regimen for drug-resistant TB. Rather the WHO recommends using a combination therapy consisting of different classes of antibiotics based on availability and local drug resistance patterns. How these new oral, bedaquiline-based second-line treatments compare to first-line therapies in their ability to kill the bacteria is not well understood and prompted the research team to conduct their research.

The Study Data

For this study, the researchers assessed 31 subjects with drug-sensitive TB who took first-line treatment (rifampin, isoniazid, ethambutol, and pyrazinamide) and 23 subjects with drug-resistant TB who took second-line treatment (bedaquiline, pyrazinamide, levofloxacin, linezolid, and clofazimine). Patients were enrolled through Weill Cornell Medicine’s partner in Haiti, the Haitian Study Group on Opportunistic Infections and Kaposi's Sarcoma, or GHESKIO.

The researchers measured the number of bacteria in the patient sputum using an automated clinical test as well as sophisticated laboratory methods capable of detecting cryptic bacteria that typically go undetected by routine methods. They then looked at the rate of the decrease in bacteria over time with therapy.

“The laboratory work to measure the quantity of bacteria in sputum is incredibly laborious and requires bio-safety level 3 facilities, so it's not something you can do on a thousand people,” said Dr. Fitzgerald, who is also the B.H. Kean Professor in Tropical Medicine and professor of medicine in microbiology and immunology at Weill Cornell Medicine.

“The rate of decline measured at two weeks was comparable in the two groups by all measures,” said study statistician Dr. Myung Hee Lee, associate professor of clinical epidemiology in medicine and associate professor of statistics. Just two months after treatment, 77.8 percent of patients from both groups tested negative for the bacterium.

“Patients who have drug-resistant TB tend to have advanced disease, and most have previously been treated with first-line drugs,” Dr. Zainabadi said. “Seeing them respond at the same rate as drug-sensitive patients to treatment is encouraging.”

The comparable response observed in the study may mean treatment can be shortened in drug-resistant patients. However, he noted that resistance to one of the other drugs in the regimen, pyrazinamide, was associated with slower killing of the bacterium during the first two weeks of therapy. These patients may need to be monitored and treated for an extended time.

These study results also support two clinical studies from other institutions, not yet published in peer-reviewed journals, that evaluated patient outcomes, Dr. Zainabadi said.

Future Research

The Weill Cornell Medicine researchers want to build on prior studies in Scientific Reports and mBio investigating better tools for monitoring the disease, Dr. Zainabadi said. “What we’re really missing is a clinical diagnostic that can accurately monitor how patients are responding to therapy, including how well regimens are killing TB, and when cure is achieved.”

The researchers are also conducting studies using the newer drugs, including bedaquiline, as an alternative to the first-line regimen in people with drug-sensitive-TB, said Dr. Fitzgerald. Some patients can’t tolerate the first-line treatment or are allergic to some of the drugs, he said.

“Overall research is moving in the direction of finding new drug regimens for TB and shorter and shorter treatments,” Dr. Fitzgerald said. “We now have options for patients.”

Reference:

Kayvan Zainabadi, Stalz Charles Vilbrun, Laurent Daniel Mathurin, Kathleen Frances Walsh, Jean William Pape, Daniel W Fitzgerald, Myung Hee Lee, A Bedaquiline, Pyrazinamide, Levofloxacin, Linezolid, and Clofazimine Second-line Regimen for Tuberculosis Displays Similar Early Bactericidal Activity as the Standard Rifampin-Based First-line Regimen, The Journal of Infectious Diseases, 2023;, jiad564, https://doi.org/10.1093/infdis/jiad564.

This condition can occur in both children and adults with hemophilia, posing significant risks to their health and well-being.Two broad types of Hemophilia are Hemophilia A and Hemophilia B, caused by deficiencies in clotting factors VIII and IX, respectively. Without these clotting factors, even minor injuries can lead to prolonged bleeding.While hemophilia is present since birth, the severity of the disease may vary and based on the severity, it is classified as Mild, moderate or severe Hemophilia. Severe Hemophilia may manifest with bleeding within the first year of life; however, moderate and mild Hemophilia may not be apparent till later in life.The Risks of Brain BleedsIn individuals with hemophilia, spontaneous bleeding can occur anywhere in the body, including the brain. Brain bleeds can result from trauma, but they can also happen spontaneously without any obvious cause. In children with hemophilia, brain bleeds can occur during childbirth or from minor head injuries common in childhood activities.In adults, brain bleeds can be triggered by trauma, but they can also happen without any apparent cause.Recognizing the SymptomsSymptoms of a brain bleed in hemophilia can vary depending on the severity and location of the bleeding. In infants and young children, signs may include excessive crying, vomiting, irritability, and changes in behaviour.In older children and adults, symptoms may include severe headache, nausea, vomiting, weakness or numbness on one side of the body, seizures, or loss of consciousness.Diagnosis and TreatmentDiagnosing a brain bleed in someone with hemophilia requires prompt medical attention. A combination of imaging tests, such as CT scans or MRI, and blood tests to assess clotting factor levels are typically used to confirm the diagnosis. Once diagnosed, treatment aims to stop the bleeding, prevent further bleeding, and manage complications.Management and PreventionManaging brain bleeds in hemophilia involves a multidisciplinary approach, including haematologists, neurologists, and other specialists. Treatment may include administration of clotting factor concentrates to replenish deficient clotting factors and stop the bleeding. In severe cases, surgery may be necessary to remove the blood clot and relieve pressure on the brain.Preventing brain bleeds in individuals with hemophilia requires careful monitoring and proactive measures. This includes regular check-ups with a haematologist to assess clotting factor levels and adjust treatment as needed. Additionally, taking precautions to prevent head injuries, such as wearing helmets during sports or activities, can help reduce the risk of brain bleeds.Understanding Prophylactic Factor TherapyProphylactic factor therapy involves regular infusions of clotting factor concentrates to maintain adequate levels in the bloodstream, effectively mimicking the role of the deficient clotting factor. This approach aims to prevent spontaneous bleeding by keeping clotting factor levels consistently high rather than waiting for bleeding episodes to occur.Maintaining stable clotting factor levels significantly reduces the risk of spontaneous bleeds, particularly in target joints like knees, elbows, and ankles, which are prone to recurrent bleeding and joint damage. Additionally, prophylaxis can improve joint health, mobility, and overall quality of life.Tailoring Prophylactic RegimensProphylactic therapy regimens are tailored to each patient based on factors such as age, the severity of hemophilia, bleeding history, lifestyle, and individual treatment goals. Regimens typically involve regular infusions of clotting factor concentrates, either weekly, biweekly, or triweekly, to maintain optimal clotting factor levels.Prophylactic factor therapy can be classified into two main types: primary prophylaxis and secondary prophylaxis (also known as episodic prophylaxis). Primary prophylaxis involves initiating treatment in young children with severe hemophilia before they experience joint damage or significant bleeding episodes. Secondary prophylaxis entails starting treatment after the onset of joint damage or recurrent bleeds, aiming to prevent further complications.Challenges and ConsiderationsDespite its efficacy, prophylactic factor therapy poses challenges, including the need for regular intravenous infusions, the potential development of inhibitors (antibodies that neutralize clotting factors), and the high cost of clotting factor concentrates.Moreover, adherence to treatment regimens and lifestyle adjustments may be challenging for some patients.Emphasizing Comprehensive CareIn addition to prophylactic factor therapy, comprehensive hemophilia care involves a multidisciplinary approach encompassing regular medical monitoring, physical therapy, joint protection strategies, and psychosocial support. Education and empowerment of patients and families are crucial for optimizing treatment outcomes and enhancing adherence to prophylactic regimens.The Importance of Education and SupportLiving with hemophilia, especially with the risk of serious complications like brain bleeds, can be challenging for patients and their families. Education about the condition, its risks, and how to manage and prevent complications is essential. Support groups and resources are available to provide information, guidance, and emotional support to individuals and families affected by hemophilia.ConclusionBrain bleeds in hemophilia pose significant risks to both children and adults with the condition. Prophylactic factor therapy is a cornerstone in the prevention of bleeding episodes and the preservation of joint health and quality of life in individuals with hemophilia. By understanding the risks, taking preventive measures, and seeking appropriate medical care, individuals with hemophilia can better manage their condition and reduce the risk of potentially life-threatening complications like brain bleeds.Disclaimer: The views expressed in this article are of the author and not of Medical Dialogues. The Editorial/Content team of Medical Dialogues has not contributed to the writing/editing/packaging of this article.

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.

Some justices suggested the Supreme Court had said its piece on abortion law when it overturned Roe v. Wade 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 University’s nursing and public health schools and Politico Magazine, Tami Luhby of CNN, and Alice Miranda Ollstein of Politico.

Panelists

Joanne Kenen
Johns Hopkins University and Politico

@JoanneKenen

Read Joanne's articles.

Tami Luhby
CNN

@Luhby

Read Tami's stories.

Alice Miranda Ollstein
Politico

@AliceOllstein

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 state’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 patients 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 jobs — often forcing those workers to move or commute to leave a position. Business interests are already suing to block the new rules, claiming 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.  

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:

• American Economic Review’s “Is There Too Little Antitrust Enforcement in the U.S. Hospital Sector?” by Zarek Brot-Goldberg, Zack Cooper, Stuart Craig, and Lev Klarnet.
• KFF Health News’ “Medical Providers Still Grappling With UnitedHealth Cyberattack: ‘More Devastating Than Covid,” by Samantha Liss.

CLICK TO OPEN THE TRANSCRIPT

Transcript: Abortion — Again — At the Supreme Court

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]

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, April 25, 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: Hello.

Rovner: Tami Luhby of CNN.

Tami Luhby: Hello.

Rovner: And Joanne Kenen of the Johns Hopkins University schools of public health and nursing and Politico Magazine.

Joanne Kenen: Hi, everybody.

Rovner: No interview this week, but wow, tons of news, so we are going to get right to it. We will start at the Supreme Court, which yesterday heard oral arguments in a case out of Idaho over whether the federal Emergency Medical Treatment and Active Labor Act, or EMTALA, trumps Idaho’s almost complete abortion ban. This is the second abortion case the high court has heard in as many months and the first to actively challenge a state’s abortion ban since the overturn of Roe v. Wade in 2022. Last month’s case, for those who have forgotten already, was about the FDA approval of the abortion pill mifepristone. Alice, you and I both listened to these arguments. Did you hear any hints on which way the court might be leaning here?

Ollstein: The usual caveat that you can’t always tell by the questions they ask. Sometimes they play devil’s advocate or it’s not indicative of how they will rule on the case, but it did seem that at least a couple of the court’s conservatives were interested in really taking a tough look at Idaho’s argument. Obviously, some of the other conservatives were very much in support of Idaho’s argument that its doctors should not be compelled to perform abortions for patients experiencing a medical emergency. It really struck me from the arguments how much it focused on what’s actually going on on the ground.

That was a huge departure from a lot of other Supreme Court arguments and a lot of Supreme Court arguments on abortion where it’s a lot of hypotheticals and getting into the legal weeds. This was just like they were reading these concrete, reported stories of what’s been happening in Idaho and other states because of these abortion bans. People turned away while they were actively miscarrying, people being flown across state lines to receive timely care. I think whether that will make a difference that the justices are sort of being confronted with the concrete ramifications of the Dobbs [v. Jackson Women’s Health Organization] decision or not remains to be seen.

Rovner: I thought one of the things that it looked like very much like last month’s argument is that the women justices were very much about real details and talking about medical conditions, about ectopic pregnancies and premature rupture of membranes and things that none of the men mentioned at all. The men were sort of very legalistic and the women, including Amy Coney Barrett, who voted to overturn Roe v. Wade, were very much all about, as you said, what’s going on on the ground and what this distinction means. I mean, where we are is that Idaho has an exception in its abortion ban, but only for the life of the woman. Whereas EMTALA says you have to stabilize someone in an emergency situation and it’s been interpreted by the federal government to say sometimes that stabilization means terminating a pregnancy, as in the case of premature rupture of membranes or an ectopic pregnancy or a case where the woman is going to hemorrhage and is actively hemorrhaging.

That question of where that line is, between what’s an immediate threat to life and what’s just a threat to health or a threat to life soon, was the crux of this case. And it really does feel uncomfortably like we have nine Supreme Court justices making, really, medical decisions.

Ollstein: Yeah, it struck me how Amy Coney Barrett seemed to get pretty frustrated with Idaho’s attorney at a couple points. Idaho’s attorney was saying kind of, “Nothing to see here. There’s no problem. Since we allow lifesaving abortions and that’s what is required under EMTALA, there’s no conflict.” So Amy Coney Barrett was like, “Well, why are you here then? Why are you before us?” The reason is that they’re trying to get this lower-court injunction lifted even though it’s not in effect right now. The other point she got kinda testy was when Idaho was saying that their law is clear, doctors know what to do, and Amy Coney Barrett asked, “Well, couldn’t a prosecutor come in later and disagree and said, “Oh, you performed an abortion you said was to save someone’s life, but I don’t think it was necessary to save her life and I’m going to charge you criminally?” And the Idaho attorney conceded that that could happen.

So I think her vote could potentially be in play, but I don’t know if it’s going to be enough to overcome the court’s conservatives who are very skeptical that EMTALA should compel states to do anything.

Rovner: So the medical community has been quite outspoken in this case. The American Medical Association, American College of Obstetricians and Gynecologists and the American College of Emergency Physicians have all filed briefs saying the Idaho ban could require them to violate professional ethics, wrote the immediate president of the AMA, Jack Resnick, in an op-ed. “It is reckless for Idaho to tell emergency physicians that they must ignore their moral and ethical standards and stand by while a septic patient begins to lose kidney function or when a hemorrhaging patient faces only a 30% chance of death.” But I feel like the medical profession has long since lost control of the abortion issue. I mean, is there any chance here that they might prevail? I have to say this week I’ve gotten so many emails from so many doctor groups saying, “Oh my goodness, look what’s happening. They’re going to put us in this impossible situation.” To which I want my response to be, “Where have you been for the last 20 years?”

Ollstein: I mean, I think it is notable that these establishment medical groups are becoming more vocal. I mean, some might say better late than never, and I think in some instances they are having an impact at the state level. They have pushed some state legislatures to add or expand exemptions to abortion bans. But a lot of times Republican lawmakers have rejected calls from state medical associations to do that, and so I think filing amicus briefs is a way to have your say, lobbying at the state level is a way to have your say. Some doctors are even running for office specifically on this issue. And also, medical groups are campaigning hard on these state abortion referendums. I reported on doctor groups door-knocking in Ohio, for instance, before that referendum won big.

I think it’s really interesting to see the medical community get a lot more vocal on something they’ve either tried to stay out of or been vocal on the other side on in the past, but we’ll have to see how much impact that actually has.

Rovner: Well, one thing this case highlights is how pregnant women who experience complications that can threaten their health or future fertility, but are not immediately life-threatening, can end up in really terrible circumstances, as we heard in a number of anecdotes at the oral arguments. The Associated Press “FOIA’d”[requested Freedom of Information Act] EMTALA pregnancy complaint records from several states with abortion bans and found some pretty horrific examples, including one woman who miscarried in the emergency room lobby restroom after she was turned away from the registration desk. Another who was turned away and ended up giving birth in a car on the way to another hospital. That baby died. These are not people who go to the emergency room in search of abortions. They’re women who are trying to maintain pregnancies. Is the concept that people ending up in the most horrific situations are often those who most want children, is that finally getting through here?

Ollstein: What struck me most about that reporting is that the documents they got were just from the first few months after Roe v. Wade was overturned, so we have no idea what’s happening now. It could be better, it could be much worse, it could be the same. I think that lack of transparency makes this really hard to report on accurately. And the fact that it took The AP a year to even get those few heavily redacted documents speaks to the challenge here. We want an accurate picture of how these bans are impacting the provision of health care around the country, and it’s really hard to get.

Rovner: I know the Biden administration has been kind of trying to keep this quiet. I mean, not out there sort of blaring what’s happening. They’ve been sort of leaving that to the politics side and this is obviously the policy side. Obviously on the politics side, the Biden administration is getting bolder about using abortion as a campaign issue. The president himself gave a speech in Florida where a six-week ban is set to take effect next week and pinned all the abortion restrictions directly on former President Trump, who he pointed out has taken credit for them. Biden actually said the word abortion twice in that speech. I was listening very closely and went back and counted. I think that’s a first. They’re definitely stepping up the pressure politically, right?

Ollstein: Yes. The Biden campaign is leaning very hard on this. Even in states where it’s debatable whether they have a chance, like Florida, I think that there’s an interest, especially after seeing all of these referendums and ballot measures win big. It’s really shown Democrats that this is a very popular issue to run on, that they shouldn’t be afraid of it, that they should lean into it. I think you are seeing attempts to do that. It’s not always the language that the abortion rights advocacy community wants to hear, but it’s definitely more than we’ve heard from the Biden administration in the past.

I think you’re also seeing an attempt to sort of take the air out of Trump’s “Let’s leave it to states. I am reasonable and moderate” sort-of pitch. By highlighting what’s happening on the ground in certain states, it’s an attempt to say, “OK, you want to leave it to states? Then you own all of this. You own every woman being turned away from a hospital while she’s miscarrying. You own every instance of a ban going into effect and people having to travel across state lines,” et cetera. But whether just blaming Trump and arguing that he would be worse is enough versus saying what Biden would actually do and continue to do, I think that’s what we’ve heard people want to hear more of. Although there has been some action from the Biden administration recently.

Rovner: That was just going to be my next question. The one policy change the Biden administration did do this week was finalized a rule expanding the health records protections under HIPAA to abortion information. Why was this important? It sounds pretty nerdy.

Ollstein: This has been in the works for more than a year. A lot of people have been wondering why it’s been taking so long and worried that if it took even longer, it would be easier to get rid of it if a new administration takes over. But essentially this is to make it harder for states to reach across state lines to try to obtain information and use it to prosecute for having an abortion. It’s an attempt to better protect that data and so we heard a lot of praise after the announcement came out from abortion rights groups and some medical groups, and I would anticipate some groups on the right would sue. I’ve seen some complaints saying this will prevent law enforcement from investigating actual crimes against people, and so I expect to see some legal challenges soon.

Kenen: There are all sorts of efforts to stop both travel for abortion. There are also laws on books already, there have been for a number of years, about helping a minor cross state lines for abortion. There’s the attempts to stop the shipment of abortion pills from a legal state into a state that has a ban. There’s all sorts of things where, whether the intent is to actually prosecute a woman or a pregnant person, versus collecting evidence for some kind of larger crackdown or prosecution, this is potentially a piece … patient records are potentially a piece of that. We’ve talked a few weeks ago, maybe a month or two ago by now, about some Texas communities that wanted to say, “If you drive on the road in our town on the way to an abortion, we’re going to arrest you.” How they figure out logistically and practically … What are you going to do? Stop everybody on the road and give them a pregnancy test?

I mean, I don’t know how you enforce that, but just that these ideas are out there and on the books through this privacy shield. We have privacy under HIPAA, all of us, so to interpret it this way, or reinforce it depending on your political point of view, undermine excessively, whatever, but this is sort of pivotal because there’s so many ways these records could be used in various kinds of legislative and prosecutorial ways.

Rovner: As you point out, it’s not theoretical. We’ve seen attorneys general — Indiana and Kansas — and some other states, actually, and Texas say that they want to go after these records, so it’s not …

Kenen: Right and we’ve seen cases of the child rape victim and the prosecutor, what happened with the doctor, and so it’s not theoretical. It’s not widespread right now, but it’s not theoretical. Whether the pregnancy was planned and wanted or it was unplanned and ended up being wanted, going through a pregnancy loss is not just medically difficult, depending on when in pregnancy it occurs and under what circumstances. It can be medically quite complicated and it’s emotionally devastating. So to just get pulled into these political legal fights when you’ve already been bleeding in the parking lot or whatever, or having lost a pregnancy, it’s like you forget these are human beings. These are people going through medical crises.

Rovner: Indeed. Well, abortion is far from the only big health news this week. On Monday, the Biden administration finalized more long-awaited rules regarding staffing in nursing homes that participate in Medicare or Medicaid. Tami, what’s in these rules and why is the concept that nursing homes should have nurses on duty so controversial?

Luhby: It is very controversial and it’s also very consequential. So on Monday, as you said, the Biden administration finalized the first-ever minimum staffing rules at nursing homes involved in Medicare and Medicaid, and they say it’s crucial for patient safety and quality of care. It requires that all nursing homes provide a total of at least 3.48 hours of nursing care per resident per day, including defined periods of care from registered nurses and from nurses’ aides. Plus, nursing homes must have a registered nurse on-site at all times, which is different than the rules now. Now, CMS [Centers for Medicare & Medicaid Services] is giving the nursing homes some time to staff up. The mandate will be phased in over three years with rural communities having up to five years and they’re also giving temporary exemptions for facilities in areas with workforce shortages that demonstrate a good faith effort to hire. When I spoke to [Department of Health and Human Services] Secretary [Xavier] Becerra about the nursing home industry’s vocal concerns that this could cause a lot of nursing homes to close or limit admissions, he said, “Well, a business model that is based on understaffing is not a very good business model and is dangerous for patients.”

So, it’s going to be a heavy lift for nursing homes. According to HHS, 75% of them will have to hire staff, including 12,000 registered nurses and 77,000 aides. And also, 22% of them will need to hire registered nurses to meet the around-the-clock mandate. The nursing home operators, not surprisingly, have strongly pushed back on this rule even back when it was first proposed in September, saying that they’re already having staffing problems amid a nationwide shortage of nurses. The American Health Care Association called the mandate an unreasonable standard that only threatens to shut down more nursing homes, displace hundreds of thousands of residents, and restrict seniors’ access to care.

Rovner: We should point out the American Health Care Association is the lobbying group for nursing homes.

Luhby: Yes. What’s interesting also, though, is that on the other side, you have advocacy groups that are saying that it doesn’t go far enough and they’re citing a 2001 CMS study that found that nursing home residents need at least 4.1 hours of daily care. To add to all of this, if it’s not complicated and controversial enough, Congress is getting involved and is also split over the rules. Some lawmakers, like Sens. Elizabeth Warren and Bob Casey, generally support it, but nearly a hundred House members from both parties wrote to HHS Secretary Becerra expressing their concern that the mandate could lead to nursing home closures. And there’s a bipartisan Senate bill and a House Republican bill that would prohibit HHS from finalizing the rule. So we have time before this goes into effect. It goes into effect in phases, and we’ll see if lawmakers move to block the mandate or if the courts do, but it’s going to be interesting to watch how this plays out.

Rovner: Joanne wanted to add something.

Kenen: Well, first of all, as we say frequently, there’s always lawsuits. We have a health care/lawsuit system, so it’s not over. But I think the other thing is I think families who put a loved one in a nursing home don’t understand how little nursing, let alone doctoring, goes on. The name is “nursing” home and people expect there to be a nurse there, meaning a registered nurse. I think people often think there’s a doctor there, where the doctors are not there very much. That’s one reason the lack of medical care on-site, not only could there be emergencies, but I mean even things that could be treated in place if there is a physician. I mean, it’s just dial 911 and put them in an ambulance and send them to the hospital. And we do have this problem with hospital readmission, which is not just a cost problem and a regulatory problem, it’s really bad for patients to … the continuity of care is good and lack of continuity and handoffs and change, sending people back-and-forth is not good for them.

Obviously, there are times there’s an emergency and you need to send someone to a hospital, but not always. If there was a doctor or nurse, there’s some things that you don’t have to call 911 for. Because you don’t know or don’t learn about nursing homes until you have a relative there or until you’re a reporter who has to write about them. You don’t realize that they’re very custodial and there’s not a lot of taken care of in terms of getting assistance in bathing and walking and things like that. There’s less medical care, including nursing care, than people realize until your loved one is there. I mean, when I covered them the first time, I was really shocked. I mean, it’s 20 years ago the first time I wrote about it, but my assumption of what was there and what is actually there was a big gap.

Rovner: Tami.

Luhby: One thing also, though is … I mean, yes, that is definitely true about the medical care, but we’re also talking about just the care, not only the nursing. But that’s why so many aides need to be hired because you also have situations in nursing homes where people aren’t getting help to go to the bathroom, aren’t getting showered regularly, aren’t being watched. Maybe they’re trying to go to the bathroom themselves and they’re falling because they have to go. I mean, unfortunately, I’ve had experience with nursing homes with my family and I’ve seen this. But also I think it’s been pretty well reported in a lot of publications and studies and such. But there are a lot of problems in nursing homes, in general, and staffing.

Rovner: Well, just to talk about how long this is going on, former Sen. David Pryor died this week. When he was a House member, he rather famously went undercover at a nursing home to try and spotlight. That was when we first started to hear about some of the conditions in nursing homes. He was instrumental in doing the work that got the original federal nursing home standards passed in 1987, which was the first time I covered this issue, and even then there was a big fight in 1987 about should there be a staffing mandate? It’s like, hello, if we’re going to improve care in nursing homes, maybe we should make sure there are enough people to provide care. Even then the nursing home industry was saying, “But we have a shortage. We can’t hire enough people to actually do this if you give us a staffing mandate.” So literally, this has gone back-and-forth since 1987. And, as Joanne points out, it’s still in all likelihood not over, but one could sort of think, gee, they’ve had two generations now to come up with enough people to work in these nursing homes. Maybe Becerra is right. Maybe there’s something wrong with the business model?

Luhby: I was going to say, we know the business model is also moving more towards private equity, which is not necessarily going to be as concerned with the staffing levels. We know that the staffing levels … I think there’ve been studies that show that staffing levels are generally lower in investor-owned nursing homes. So there’s that.

Kenen: There’ve been a lot of demographic changes. I mean, you live longer, but you don’t always live healthier. We have families that are spread out. Not everybody’s living in the same town anymore. I mean, they haven’t for a number of decades now, but your daughter-in-law is 3,000 miles away. She can’t come to your house every day. At the same time, we do have a push and it’s not brand-new, it’s a number of years now, to do more home- and community-based care, but there are shortages and waiting lists and problems there, too. So there are a lot of people who need institutional care. Whether they wanted to have that or not, that’s where they go because either there’s not enough community support or they don’t have the family to fill in the gaps or they’re too medically complicated or whatever. Given the demographic trends and the degree of chronic disease and disability, this is not going away. It’s like Julie said, it’s way overdue. We need to figure it out. There are workforce shortages to train more CRNAs [certified registered nurse anesthetists] like the trained aides. It’s not a five-, six-year program. I mean, this can be done and is done somewhere in community colleges. You can do this. You can improve at all levels. You need more nurse RNs, nurses or advanced practice nurses, but you also need more of everything else. People who go to work in these jobs, by and large, do want to provide quality, compassionate care, and it’s hard to do if there are not enough of you.

Rovner: But they’re also super hard jobs and super stressful and super physically demanding.

Kenen: Hoisting and …

Rovner: Yeah, yeah. And not well-paid.

Kenen: Keeping track of a lot of stuff.

Rovner: Well, in a related move, the Biden administration this week also finalized rules that will attempt to make the quality of Medicaid managed-care plans more transparent. Among other things, the rules establish national wait time limits for certain types of medical care and require states to conduct secret shopper surveys of insurance provider networks to make sure there are enough practitioners available to serve the patient population. The administration says these rules are needed because so many Medicaid patients are now in managed care and regulations just haven’t kept up. Will these be enough to actually protect these often very vulnerable populations? I mean, obviously these people are not quite as vulnerable as people in nursing homes, but they’re kind of the next level down.

Kenen: Well, I think that we’ve seen a history of waves of regulation. Then whatever the status quo becomes, it doesn’t stay the status quo. Whether, as Tami mentioned, there’s more private equity or there’s monopolization and consolidation or just new state regulation. I mean, it’s not static. Do we know how this move is going to play out? No. Do we assume that the bad actors who don’t want to comply will find new ways of doing things that in five years we’ll have another set of regulations that we’ll be talking about? I mean, unfortunately, that’s the way things work. Some regulatory approaches or legal approaches work and others just sort of morph. There’s a lot of history of innovative great actors and lousy bad actors.

Rovner: I say it’s been a big week for federal regulation because we also have breaking news from the Federal Trade Commission, of all places. On Tuesday, the commissioners voted to finalize rules banning most noncompete clauses in employment contracts. At an event here at KFF, the FTC chair, Lina Kahn, said a surprisingly large number of comments about that proposed rule came from health care workers. Here’s a snippet from that conversation.

Lina Khan: There were a whole bunch of comments that said, “I signed this, but it’s not like I was exercising real choice. It felt coercive.” We also heard a lot about the effect of these noncompetes and the way that, especially in rural areas, if you want to switch employers and there’s really only one other option locally, if a noncompete is barring you from taking a job with that other hospital, practically to change jobs you have to leave the state. Right? And just how destructive and devastating that is for people and their families, especially if they’re choosing between staying in a job where the employer realizes that this is a captive employee and they don’t really have to compete in offering them better opportunities, better wages, and having to instead think about uprooting their family. We also heard from doctors who did not uproot their families, but instead just commuted hours and hours a day driving. People saying, “For five years I didn’t really see my kids at all awake, ever, because I was always on the road because of this noncompete.” So just really vivid stories from people.

Rovner: So even though the vote was less than 48 hours ago, the U.S. Chamber of Commerce has already filed suit to block the rules as have some smaller business groups. Why do businesses think they need to prevent workers from changing jobs near where they live? I mean, you could see it for people who’ve invented something. You don’t want them to walk out the door with proprietary secrets, but baristas at Starbucks and even nurses are not walking out with trade secrets.

Kenen: Well, I mean, this is common in doctors’ employment contracts, nurses, it’s everything. I think it’s partly because there are provider shortages in some places and they want to keep the workforce they have instead of having them be lured across town to a competitor where they could be paid more and then you have to pay even more to hire the next one. So that’s part of it. It’s economic. A lot of it’s economic. I mean, there’s some fear of patients going with a certain beloved provider, a doctor goes somewhere else. But I think it’s basically they don’t want churn. They don’t want to have to keep paying more. Somebody gets a job offer across the street and they don’t want to take it. They like where they are, but they’re going to ask for more money. It’s largely economic in a market where there’s scarcity of some specialties and certainly nursing. I mean, there’s questions about are there are not enough nurses? Or are we just putting them in the wrong places? But speaking generally, there’s a nursing shortage and physicians, we don’t have enough primary care providers. We certainly don’t have enough geriatricians. We don’t have enough mental health providers. We don’t have enough of a lot of things. This helps the employer, in this case, the health system, usually.

Rovner: I have to say it was only in the last couple of years that I even became aware there were noncompetes in health care. I mean, I knew about them for weathercasters on local stations. It’s like if you leave, you have to go to another station in another city. I had absolutely no idea that they were so common, as you point out, for so many economic reasons. Obviously this has also already been challenged in court, so we’ll have to see how that plays out.

Also this week on the antitrust front, we have a paper from three health economists published in the American Economic Review who calculated that if the Federal Trade Commission had been more aggressive about flagging and potentially blocking hospital mergers just between 2010 and 2015, health care prices could have been 5% lower. Researchers blame the FTC’s limited budget, but you have to wonder if that budget is limited because business has so much clout in Washington and really doesn’t want eager regulators snooping into their potentially anticompetitive practices. I mean, the FTC has been around for 120-some years now. Occasionally it tries to do big things like with these noncompetes, but mostly it doesn’t do as much as obviously economists and people who study it think that it could do. I mean, we certainly have problems with lack of competition in health care.

Ollstein: I think we have an unusually aggressive FTC right now, so it’ll be really interesting to see what they can accomplish in whatever time this administration has remaining to it, which remains to be seen. I have seen some more aggressive action from the agency in the past on things like payday lending and some of these other sort of maybe more fringy sectors of the economy. So to take on health care, which is so central and such a behemoth and, like you said, there’s so much political power behind it, as Joanne said, guarantee of lawsuits and coverage from us forever basically.

Kenen: The other point that’s worth making, I don’t think any of us have said this, it doesn’t apply to nonprofit hospitals or health systems, and that’s a lot of … market-dominant health care systems that are nonprofits, nominally their tax status is nonprofit. It’s a very confusing term to normal people, but these bans on noncompetes do not apply to the nonprofit sector, which is a lot of health care.

Rovner: Yet still it’s set off quite a conflagration since they passed this on Tuesday. Well, finally this week, speaking of big health care business, we are still seeing ramifications from that Change Healthcare hack back in February. While UnitedHealth Group, which owns Change, says things are approaching normality, that’s not the case for providers who still can’t submit bills or collect payments except doing it on paper. Meanwhile, in what’s going to be some kind of movie or miniseries someday, a second group is now demanding ransom after publishing some of the stolen data. If you’ve been following this story along with us, you’ll remember that United reportedly already paid a ransom of $22 million, except that it appears that the group that got that money stiffed the group that actually has control of the pirated data.

Oh, and buried in UnitedHealthcare’s news “update” posted on its website, it says protected health information, “which could cover a substantial proportion of people of America,” is involved in the hack. Can this get any worse?

Kenen: Snakes? I don’t think any of us journalists can quite comprehend. I mean, we understand intellectually, but I don’t think we understand what it’s like to be the billing clerk at a major practice right now trying to figure out what’s where and how to get paid and what it means for patients and what’s next. I mean, this is a tremendous hack, but it’s not the last.

Rovner: Yeah, and the idea that I think — what did they say? — 1 out of every 3 health care transactions goes through Change, I certainly wasn’t aware of. I think most reporters who are covering this weren’t aware of. I think certainly none of the public was aware of, that there’s that much of the money-changing that goes on from one, as we now know, vulnerable organization is a little bit scary.

Luhby: It shows the power of UnitedHealth[care] in the market. I mean, it’s the largest insurer and people think of it, “OK, I have insurance through it,” but they don’t realize all of the other tentacles that are attached.

Kenen: It also shows that there’s hack after hack after hack after hack. This company knew that they were big and powerful and central, and many of us never heard of them or barely knew what they were. But they knew what they were and despite all the warnings of the need for better and higher protection, cybersecurity protections, these things are going on still. I don’t have the technical expertise to know, well, OK, everybody’s doing everything they’re supposed to do as a health system, but the hackers are just always a step ahead. Or whether they’re really not doing everything they’re supposed to do and weak links in their own chains. Is it the diabolical geniuses? Or is it people still not taking this seriously enough?

Rovner: I will add that in our discussion with FTC Chair Lina Kahn, she did talk about cybersecurity as something that the FTC is going to be looking at in deciding whether there is unfair competition going on. Also, she has promised to come on the podcast, so hopefully we will get her in the next several weeks.

All right, that is the news for this week. Now 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. Tami, you were the first in, why don’t you go first this week?

Luhby: Well, my extra credit is an AP story by Emily Wagster Pettus titled “Mississippi Lawmakers Haggle Over Possible Medicaid Expansion as Their Legislative Session Nears End.” This story brings us up to date on the negotiations between the House and Senate in Mississippi over expanding Medicaid. Just a quick refresher for listeners: Mississippi is one of 10 states that hasn’t expanded Medicaid yet, and this is the first time, and it’s really very consequential that the Republican-led legislature has seriously considered doing so. The problem is the House and Senate versions are very, very different. The House bill is more like a traditional Medicaid expansion, providing coverage for those earning up to 138% of the poverty level, although it would also try to institute a work requirement, and about 200,000 people would gain coverage. But the Senate version would only extend coverage to those earning up to 100% of the poverty level, which the Senate Medicaid committee chair thought would add about 40,000 to the program, and it would also come with a very strict work requirement.

So on Tuesday, lawmakers met to try to hash out a compromise. They did so in public. It was a public meeting recorded, which was very unusual, and apparently there were people waiting hours to get in. It was standing room only. The House offered a plan that would cover people earning up to 100% of the poverty level under Medicaid, while those earning between 100% and 138% would receive subsidies to buy insurance through the ACA exchange. But the Senate did not offer a proposal nor immediately respond to the one in the House. There are more meetings scheduled. I think there was another one yesterday. It remains to be seen what will happen, but the clock is ticking. The state legislature only is in session until May 5, and it doesn’t give them much time.

Another wrinkle is that it’s important to note that Gov. Tate Reeves, a Republican, has repeatedly voiced his opposition to Medicaid expansion in recent months and is likely to veto any bill. So if lawmakers do eventually agree on a compromise, they may very well also have to vote on whether to override the veto by the governor. This happened in Kansas in 2017 where the legislature did pass Medicaid expansion, Republican governor vetoed it, and the legislature was not able to override the veto and it never got that far again.

Rovner: So yes, we will keep our eyes on Mississippi. Thank you for the update. Alice, why don’t you go next?

Ollstein: I have a piece from States Newsroom related to the Supreme Court arguments on Idaho’s abortion ban and its impact on pregnant patients. The piece [“Loss of Federal Protection in Idaho Spurs Pregnant Patients To Plan for Emergency Air Transport”] is about the increase in patients being airlifted out of the state on these Life Flight [Network] emergency transports and the situation and doctors’ hesitancy to provide abortion care, even when they feel it’s medically necessary, is leading to this increase in flying patients to Oregon and Washington and Utah and neighboring states. It’s getting to the point where some doctors are even recommending people who are pregnant or planning to be pregnant purchase memberships in these flight companies, which normally is only recommended for people who do extreme outdoor sports who may need to be rescued or who ride motorcycles. So the fact that just being pregnant is becoming a category in which you are recommended to have this kind of insurance is pretty wild.

Rovner: Yeah. Welcome to 2024. Joanne.

Kenen: This is a piece from the Missouri Independent, which is also part of the States Newsroom, by Rudi Keller, and the headline is “Missouri Prison Agency To Pay $60K for Sunshine Law Violations Over Inmate Death Records.” That doesn’t sound quite as dramatic as this story really is. It’s about a mother who’s been trying to find out how her son was left unprotected, and he died by suicide, hanged himself in solitary confinement, when he had a history of mental illness. He was serving time for robbery. He wasn’t a murderer. I mean, he was obviously in prison. He had done something wrong, very wrong. He had had a 13-year sentence. But he had a history of mental illness. He had a history of past suicide attempts. He had been taken off some of his drugs, and she has been trying to find out what happened. But it’s not just her. There are other cases. The number of deaths in Missouri prisons has actually gone up in the last few years, even though the prison population itself has gone down. The headline is sort of the tip of a rather sad iceberg.

Rovner: Prison health care, I think, is something that people are starting to look at more closely, but there’s a lot of stories there to be done. Well, my story this week is from my friend and former colleague Liz Szabo, and it’s called “Women Are Less Likely To Die When Treated by Female Doctors, Study Suggests.” Now, this was a study of women on Medicare who were hospitalized, so not everybody, and the difference was small, but statistically significant. Those women treated by women doctors were slightly less likely to die in the ensuing 30 days than those treated by male doctors. It’s not entirely clear why, but at least part of it is that women tend to take other women’s problems more seriously, and women patients may be more likely to open up to other women doctors.

It’s another data point in trying to close the gap between women and men and the gap between people of color and white people when it comes to health care. So more studies to come.

OK, that is our show. 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 technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions to whatthehealth, all one word, @kff.org. Or you can still find me at X, I’m @jrovner. Joanne, where do you hang these days?

Kenen: Occasionally on X @JoanneKenen, but not very much, and on threads @joannekenen1.

Rovner: Tami?

Luhby: Best place is cnn.com.

Rovner: There you go. Alice?

Ollstein: @AliceOllstein on X, and @alicemiranda on Bluesky.

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

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The U.S. Centers for Disease Control and Prevention (CDC) issued an official health alert advisory on Tuesday warning about reports of fake Botox injections that have landed some patients in the hospital.

Along with the U.S. Food and Drug Administration (FDA) and state and local health officials, the CDC said it is investigating a total of 22 cases across 11 states starting in Nov. 2023 through March 2024.

Cases have so far been reported in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York City, Tennessee, Texas and Washington — all affecting women between 25 and 59 years of age. 

WHAT EXACTLY IS BOTOX?

The women have experienced "adverse effects" after being injected with "counterfeit botulinum toxin," the alert said.

The injections were all given by "unlicensed or untrained individuals" or in "non-health care settings, such as homes or spas."

The women's reported symptoms included blurred vision, drooping eyelids, dry mouth, fatigue, slurred speech, generalized weakness and shortness of breath.

Of the 22 cases, 11 women were hospitalized. 

None of the instances met the "case definition for botulism," the CDC noted.

No deaths have been reported.

Botulism is a "serious and sometimes fatal" illness that occurs when a toxin attacks the body’s nerves, according to the CDC.

Initial symptoms usually include muscle weakness around the eyes, face, mouth and throat — which could also spread to the neck, arms, torso and legs. 

ARTIFICIAL BEAUTY: WARNING OF THREATS TO GIRLS’ SELF-ESTEEM, DOVE RECOMMITS TO NEVER USING AI IN ADS

Other symptoms can include blurred or double vision, difficulty breathing, trouble swallowing, drooping eyelids, slurred speech and difficulty moving the eyes.

It is possible for people to experience some of these symptoms without having botulism.

Dr. Anne Truitt, a board-certified dermatologist in San Diego, California, said that doctors or clinicians injecting Botox or other injectables should ensure that the products come from a reputable source.  

"Injecting an unknown product at unknown concentrations into your body is really dangerous and potentially fatal," she told Fox News Digital.

Dr. Craig Lehrman, director of aesthetic surgery at The Ohio State University Wexner Medical Center, noted that fake Botox has been an issue since the early 2000s.

"Unfortunately, I treat several patients a year who have received non-approved injectables of things they are told to be safe — which ends up having serious consequences," he told Fox News Digital.

CALIFORNIA PLASTIC SURGERY 'ADDICT’ DISSOLVES FILLER TO ‘EMBRACE BEAUTY’ AFTER SPENDING $50K ON PROCEDURES

"It has mostly been linked to injections in settings such as someone's home or a poorly regulated med spa."

Botox is made from a specific type of Clostridium botulinum, a bacteria that produces paralysis in the muscles where it is injected, he said.

"The people receiving the presumed counterfeit Botox are suffering from an illness that is similar to botulism, caused by the same bacteria," he said.

There are strict safety criteria for the use and storage of Botox, and serious risks come with the injection of fraudulent or poorly managed products, Lehrman warned. 

"Botulism can carry detrimental effects ranging from infection, to permanent deformity, to serious wound formation."

"​​Cosmetic injections should be an FDA-approved product, administered by licensed providers and in licensed settings," the CDC stated. 

There has been a large increase in the number of people offering these services who are not board-certified in the fields of plastic surgery, dermatology or ENT, according to Lehrman. 

"I would advise potential patients to do their research on the person who will be injecting them — and not just search for the cheapest option," he said. 

"I would recommend going to a center that has rigorous standards of education and a track record of safety."

PLASTIC SURGERY DEATHS HAVE SPIKED AMONG US PATIENTS WHO TRAVELED TO DOMINICAN REPUBLIC: CDC REPORT

In most cases, when administered properly, Botox injections are safe, according to experts.

"Botox has been well-tested and researched for many years," Truitt told Fox News Digital. "Used appropriately, it is safe and one of the best tools to reduce the effects of aging."

"Laboratory-confirmed cases of systemic botulism occurring after cosmetic or therapeutic injections of botulinum toxin are rare," the CDC said in its statement.

To ensure safety, Truitt said it's important to go to a licensed provider, and to avoid "Botox parties" and "pop-up" med spas.

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"The bottom line is that if it sounds too good to be true, then chances are it probably isn't true — or safe," she added.

Anyone who experiences botulism-like symptoms following an injection should seek medical attention, according to health officials.

Fox News Digital reached out to Abbvie (manufacturer of Botox) and the FDA requesting additional comment.

For more Health articles, visit www.foxnews.com/health.

MENTAL HEALTH is important at every stage of life, from childhood and adolescence through to adulthood. Mental health includes our emotional, psychological, and social well-being. It affects how we think, feel, and act; and it also helps determine...