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Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patients

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Dawn Megli
Wed, 31 Jan 2024 10:00:00 +0000

In late 2022, Sarah Gutilla's treatment-resistant depression had grown so severe, she was actively contemplating suicide. Raised in foster care, the 34-year-old's childhood was marked by physical violence, sexual abuse, and drug use, leaving her with -threatening mental scars.

Out of desperation, her husband scraped together $600 for the first of six rounds of intravenous ketamine therapy at Ketamine Clinics Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. When Gutilla got into an Uber for the 75-mile drive to Los Angeles, it was the first time she had left her home in Llano, California, in two years. The results, she said, were instant.

“The amount of relief I felt after the first treatment was what I think ‘normal' is supposed to feel like,” she said. “I've never felt so OK, and so at peace.”

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For-profit ketamine clinics have proliferated over the past few years, offering infusions for a wide array of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Although the off-label use of ketamine hydrochloride, a Schedule III drug approved by the FDA as an anesthetic in 1970, was considered radical just a decade ago, now between 500 and 750 ketamine clinics have cropped up across the nation.

Market researcher Grand View Research pegged industry revenues at $3.1 billion in 2022, and projects them to more than double to $6.9 billion by 2030. Most insurance doesn't ketamine for mental health, so patients must pay out-of-pocket.

While it's legal for doctors to prescribe ketamine, the FDA hasn't approved it for mental health treatment, which means that individual practitioners must develop their own treatment protocols. The result is wide variability among providers, with some favoring gradual, low-dosage treatments while others advocate larger amounts that can induce hallucinations, as the drug is psychedelic at the right doses.

“Ketamine is the wild West,” said Dustin Robinson, the managing principal of Iter Investments, a venture capital firm specializing in hallucinogenic drug treatments.

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Ketamine practitioners stress that the drug's emergence as a mental health treatment is driven by a desperate need. Depression is the leading cause of disability in the United States for individuals ages 15-44, according to the National Institute of Mental Health, and around 25% of adults experience a diagnosable mental disorder in any given year.

Meanwhile, many insurance plans cover mental health services at lower rates than physical health care, despite laws requiring parity. Thus many patients with disorders receive little or no care early on and are desperate by the time they visit a ketamine clinic, said Steven Siegel, chair of psychiatry and the behavioral sciences at the of Southern California's Keck School of Medicine.

But the revelation that “Friends” star Matthew Perry died in part from a large dose of ketamine, along with billionaire Elon Musk's open use of the drug, has piqued fresh scrutiny of ketamine and its regulatory , or lack thereof.

Commercial ketamine clinics often offer same-day appointments, in which patients can pay out-of-pocket for a drug that renders immediate results. The ketamine is administered intravenously, and patients are often given blankets, headphones, and an eye mask to heighten the dissociative feeling of not being in one's body. A typical dose of ketamine to treat depression, which is 10 times lower than the dosage used in anesthesia, costs clinics about $1, but clinics charge $600-$1,000 per treatment.

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Ketamine is still shadowed by its reputation as the party drug known as “Special K”; Siegel's first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It has the potential to send users down a “K hole,” otherwise known as a bad trip, and can induce psychosis. Research in animals and recreational users has shown chronic use of the drug impairs both short- and long-term cognition.

Perry's death in October raised alarms when the initial toxicology screening attributed his death to the acute effects of ketamine. A December report revealed Perry received infusion therapy a before his death but that the fatal blow was a high dose of the substance taken with an opioid and a sedative on the day of his death — indicating that medical ketamine was not to blame.

A Variety of Protocols

Sam Mandel co-founded Ketamine Clinics Los Angeles in 2014 with his father, Steven Mandel, an anesthesiologist with a background in clinical psychology, and Sam said the clinic has established its own protocol. That includes monitoring a patient's vital signs during treatment and keeping psychiatrists and other mental health practitioners on standby to ensure safety. Initial treatment starts with a low dose and increases as needed.

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While many clinics follow the Mandels' graduated approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is geared toward triggering a psychedelic episode.

Christina Thomas, president of MY Self Wellness, said she developed her clinic's procedures against a list of “what not to do” based on the bad experiences people have reported at other clinics.

The field isn't entirely unregulated: medical and nursing boards oversee physicians and nurses, while the FDA and Drug Enforcement Administration regulate ketamine. But most anesthesiologists don't have a background in mental health, while psychiatrists don't know much about anesthesia, Sam Mandel noted. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, particularly because ketamine can affect vital signs such as blood pressure and respiration.

The protocols governing Spravato, an FDA-approved medication based on a close chemical cousin of ketamine called esketamine, are illustrative. Because it has the potential for serious side effects, it falls under the FDA's Risk Evaluation and Mitigation Strategies program, which puts extra requirements in place, said Robinson. Spravato's REMS requires two hours of monitoring after each dose and prohibits patients from driving on treatment days.

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Generic ketamine, by contrast, has no REMS requirements. And because it is generic and cheap, drugmakers have little financial incentive to undertake the costly clinical trials that would be required for FDA approval.

That leaves it to the patient to assess ketamine providers. Clinics dedicated to intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, practitioners should have mental health and anesthesia expertise, or have multiple specialties under one roof, and clinics should be equipped with hospital-grade monitoring equipment, Mandel said.

Siegel, who has researched ketamine since 2003, said the drug is especially useful as an emergency intervention, abating suicidal for long enough to give traditional treatments, like talk therapy and SSRI antidepressants, time to take effect. “The solutions that we have and have had up until now have failed us,” Mandel said.

The drug is now popular enough as a mental health treatment that the name of Mandel's clinic is a sight for thousands of Angelenos as it appears on 26 Adopt-A-Highway signs along the 405 and 10 freeways.

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And the psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or molly, is expected to receive FDA approval in 2024. A drug with psilocybin, the active ingredient in “magic mushrooms,” could launch as early as 2027, the same year a stroke medicine with the active ingredient of DMT, a hallucinogen, is expected to debut.

Robinson said many ketamine clinics have opened in anticipation of the expanded psychedelic market. Since these new drugs will likely be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravato so they'll have the proper insurance and staff in place.

For now, Sarah Gutilla will pay out-of-pocket for ketamine treatments. One year after her first round of infusions, she and her husband are saving for her second. In the meantime, she spends her days on her ranch in Llano where she rescues dogs and horses, and relies on telehealth therapy and psychiatric medications.

While the infusions aren't “a magic fix,” they are a tool to her move in the right direction.

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“There used to be no light at the end of the tunnel,” she said. “Ketamine literally saved my life.”

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By: Dawn Megli
Title: Ketamine Therapy for Mental Health a ‘Wild West' for Doctors and Patients
Sourced From: kffhealthnews.org/news/article/ketamine-therapy-hallucinogenic-mental-health-unregulated/
Published Date: Wed, 31 Jan 2024 10:00:00 +0000

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Kaiser Health News

KFF Health News’ ‘What the Health?’: Newly Minted Doctors Are Avoiding Abortion Ban States

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Thu, 09 May 2024 19:30:00 +0000

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

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

A new analysis finds that graduating medical students were less likely to apply this year for residency in states that ban or restrict abortion. That was true not only for aspiring OB-GYNs and others who regularly treat pregnant patients, but for all specialties.

Meanwhile, another study has found that more than 4 million have been terminated from Medicaid or the Children's Health Insurance Program since the federal government ended a covid-related provision barring such disenrollments. The study estimates about three-quarters of those children were still eligible and were kicked off for procedural reasons.

This week's panelists are Julie Rovner of KFF Health News, Lauren Weber of The Washington Post, Joanne Kenen of the Johns Hopkins University schools of nursing and public health and Politico Magazine, and Anna Edney of Bloomberg News.

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Panelists

Anna Edney
Bloomberg


@annaedney


Read Anna's stories.

Joanne Kenen
Johns Hopkins University and Politico

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@JoanneKenen


Read Joanne's articles.

Lauren Weber
The Washington Post


@LaurenWeberHP

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Read Lauren's stories.

Among the takeaways from this week's episode:

  • More medical students are avoiding applying to residency programs in states with abortion restrictions. That could worsen access problems in that already don't have enough and other health providers in their communities.
  • New threats to abortion care in the United States include not only laws penalizing abortion pill possession and abortion travel, but also online misinformation campaigns — which are trying to discourage people from supporting abortion ballot measures by telling them lies about how their information might be used.
  • The latest news is out on the fate of Medicare, and a pretty robust economy appears to have bought the program's trust fund another five years. Still, its overall health depends on a long-term solution — and a long-term solution depends on Congress.
  • In Medicaid expansion news, Mississippi lawmakers' latest attempt to expand the program was unsuccessful, and a report shows two other nonexpansion states — and Florida — account for about 40% of the 4 million kids who were dropped from Medicaid and CHIP last year. By not expanding Medicaid, holdout states say no to billions of federal dollars that could be used to health care for low-income .
  • Finally, the bankruptcy of the hospital chain Steward Health Care tells a striking story of what happens when private equity invests in health care.

Also this week, Rovner interviews KFF Health News' Katheryn Houghton, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a patient who went outside his insurance network for a surgery and thought he had covered all his bases. It turned out he hadn't. If you have an outrageous or incomprehensible medical bill you'd like to share with us, you can do that here.

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

Julie Rovner: The Nation's “The Abortion Pill Underground,” by Amy Littlefield.

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Joanne Kenen: The New York Times' “In Medicine, the Morally Unthinkable Too Easily Comes to Seem Normal,” by Carl Elliott.

Anna Edney: ProPublica's “Facing Unchecked Syphilis Outbreak, Great Plains Tribes Sought Federal Help. Months Later, No One Has Responded,” by Anna Maria Barry-Jester.

Lauren Weber: Stat's “NYU Professors Who Defended Vaping Didn't Disclose Ties to Juul, Documents Show,” by Nicholas Florko.

Also mentioned on this week's podcast:

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Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News' “What the Health?” on SpotifyApple PodcastsPocket Casts, or wherever you listen to podcasts.

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Title: KFF Health News' ‘What the Health?': Newly Minted Doctors Are Avoiding Abortion Ban States
Sourced From: kffhealthnews.org/news/podcast/what-the-health-346-abortion-ban-residency-decline-may-9-2024/
Published Date: Thu, 09 May 2024 19:30:00 +0000

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Kaiser Health News

Medical Residents Are Increasingly Avoiding States With Abortion Restrictions

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Julie Rovner, KFF Health and Rachana Pradhan
Thu, 09 May 2024 12:01:00 +0000

Isabella Rosario Blum was wrapping up medical school and considering residency programs to become a family practice physician when she got some frank advice: If she wanted to be trained to abortions, she shouldn't stay in Arizona.

Blum turned to programs mostly in states where access — and, by extension, abortion training — is likely to remain protected, like California, Colorado, and New Mexico. Arizona has enacted a law banning most abortions after 15 weeks.

“I would really like to have all the training possible,” she said, “so of course that would have still been a limitation.”

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In June, she will start her residency at Swedish Cherry Hill hospital in Seattle.

According to new statistics from the Association of American Medical Colleges, for the second year in a row, students graduating from U.S. medical schools were less likely to apply this year for residency positions in states with abortion bans and other significant abortion restrictions.

Since the Supreme Court in 2022 overturned the constitutional right to an abortion, fights over abortion access have created plenty of uncertainty for pregnant and their doctors. But that uncertainty has also bled into the world of medical education, forcing some new doctors to factor state abortion laws into their decisions about where to begin their careers.

Fourteen states, primarily in the Midwest and South, have banned nearly all abortions. The new analysis by the AAMC — a preliminary copy of which was exclusively reviewed by KFF Health News before its public release — found that the number of applicants to residency programs in states with near-total abortion bans declined by 4.2%, compared with a 0.6% drop in states where abortion remains legal.

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Notably, the AAMC's findings illuminate the broader problems abortion bans can create for a state's medical community, particularly in an era of provider shortages: The organization tracked a larger decrease in interest in residencies in states with abortion restrictions not only among those in specialties most likely to treat pregnant patients, like OB-GYNs and emergency room doctors, but also among aspiring doctors in other specialties.

“It should be concerning for states with severe restrictions on reproductive rights that so many new physicians — across specialties — are choosing to apply to other states for training instead,” wrote Atul Grover, executive director of the AAMC's Research and Action Institute.

The AAMC analysis found the number of applicants to OB-GYN residency programs in abortion ban states dropped by 6.7%, compared with a 0.4% increase in states where abortion remains legal. For internal medicine, the drop observed in abortion ban states was over five times as much as in states where abortion is legal.

In its analysis, the AAMC said an ongoing decline in interest in ban states among new doctors ultimately “may negatively affect access to care in those states.”

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Jack Resneck Jr., immediate past president of the American Medical Association, said the data demonstrates yet another consequence of the post- era.

The AAMC analysis notes that even in states with abortion bans, residency programs are filling their positions — mostly because there are more graduating medical students in the U.S. and abroad than there are residency slots.

Still, Resneck said, “we're extraordinarily worried.” For example, physicians without adequate abortion training may not be able to manage miscarriages, ectopic pregnancies, or potential complications such as infection or hemorrhaging that could stem from pregnancy loss.

Those who work with students and say their observations the AAMC's findings. “People don't want to go to a place where evidence-based practice and human rights in general are curtailed,” said Beverly Gray, an associate professor of obstetrics and gynecology at Duke University School of Medicine.

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Abortion in North Carolina is banned in nearly all cases after 12 weeks. Women who experience unexpected complications or discover their baby has potentially fatal birth defects later in pregnancy may not be able to receive care there.

Gray said she worries that even though Duke is a highly sought training destination for medical residents, the abortion ban “impacts whether we have the best and brightest coming to North Carolina.”

Rohini Kousalya Siva will start her obstetrics and gynecology residency at MedStar Washington Hospital Center in Washington, D.C., this year. She said she did not consider programs in states that have banned or severely restricted abortion, applying instead to programs in Maryland, New Hampshire, New York, and Washington, D.C.

“We're physicians,” said Kousalya Siva, who attended medical school in Virginia and was previously president of the American Medical Student Association. “We're supposed to be giving the best evidence-based care to our patients, and we can't do that if we haven't been given abortion training.”

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Another consideration: Most graduating medical students are in their 20s, “the age when people are starting to think about putting down roots and starting families,” said Gray, who added that she is noticing many more students ask about politics during their residency interviews.

And because most young doctors make their careers in the state where they do their residencies, “people don't feel safe potentially having their own pregnancies living in those states” with severe restrictions, said Debra Stulberg, chair of the Department of Family Medicine at the University of Chicago.

Stulberg and others worry that this self-selection away from states with abortion restrictions will exacerbate the shortages of physicians in rural and underserved areas.

“The geographic misalignment between where the needs are and where people are choosing to go is really problematic,” she said. “We don't need people further concentrating in urban areas where there's already good access.”

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After attending medical school in Tennessee, which has adopted one of the most sweeping abortion bans in the nation, Hannah Light-Olson will start her OB-GYN residency at the University of California-San Francisco this summer.

It was not an easy , she said. “I feel some guilt and sadness leaving a situation where I feel like I could be of some ,” she said. “I feel deeply indebted to the program that trained me, and to the patients of Tennessee.”

Light-Olson said some of her fellow students applied to programs in abortion ban states “because they think we need pro-choice providers in restrictive states now more than ever.” In fact, she said, she also applied to programs in ban states when she was confident the program had a way to provide abortion training.

“I felt like there was no perfect, 100% guarantee; we've seen how fast things can change,” she said. “I don't feel particularly confident that California and New York aren't going to be under threat, too.”

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As a condition of a scholarship she received for medical school, Blum said, she will have to return to Arizona to practice, and it is unclear what abortion access will look like then. But she is worried about long-term impacts.

“Residents, if they can't get the training in the state, then they're probably less likely to settle down and work in the state as well,” she said.

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By: Julie Rovner, KFF Health News and Rachana Pradhan
Title: Medical Residents Are Increasingly Avoiding States With Abortion Restrictions
Sourced From: kffhealthnews.org/news/article/medical-students-residents-spurning-abortion-ban-states/
Published Date: Thu, 09 May 2024 12:01:00 +0000

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Paid Sick Leave Sticks After Many Pandemic Protections Vanish

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Zach Dyer
Thu, 09 May 2024 09:00:00 +0000

Bill Thompson's wife had never seen him smile with confidence. For the first 20 years of their relationship, an infection in his mouth robbed him of teeth, one by one.

“I didn't have any teeth to smile with,” the 53-year-old of Independence, Missouri, said.

Thompson said he dealt with throbbing toothaches and painful swelling in his face from abscesses for years working as a cook at Burger King. He desperately needed to see a dentist but said he couldn't afford to take time off without pay. Missouri is one of many states that do not require employers to provide paid sick leave.

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So, Thompson would swallow Tylenol and push through the pain as he worked over the hot grill.

“Either we go to work, have a paycheck,” Thompson said. “Or we take care of ourselves. We can't take care of ourselves because, well, this vicious circle that we're stuck in.”

In a nation that was sharply divided about government health mandates during the pandemic, the public has been warming to the idea of government rules providing for paid sick leave.

Before the pandemic, 10 states and the District of Columbia had laws requiring employers to provide paid sick leave. Since then, Colorado, New York, New Mexico, Illinois, and Minnesota have passed laws offering some kind of paid time off for illness. Oregon and California expanded previous paid leave laws. In Missouri, Alaska, and Nebraska, advocates are pushing to put the issue on the ballot this fall.

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The U.S. is one of nine countries that do not guarantee paid sick leave, according to data compiled by the World Policy Analysis Center.

In response to the pandemic, Congress passed the Emergency Paid Sick Leave and Emergency Family and Medical Leave Expansion acts. These temporary measures allowed employees to take up to two weeks of paid sick leave for covid-related illness and caregiving. But the provisions expired in 2021.

“When the pandemic hit, we finally saw some real political will to solve the problem of not federal paid sick leave,” said economist Hilary Wething.

Wething co-authored a recent Economic Policy Institute report on the state of sick leave in the United States. It found that more than half, 61%, of the lowest-paid workers can't get time off for an illness.

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“I was really surprised by how quickly losing pay — because you're sick — can translate into immediate and devastating cuts to a family's household budget,” she said.

Wething noted that the lost wages of even a day or two can be equivalent to a month's worth of gasoline a worker would need to get to their job, or the choice between paying an electric bill or buying food. Wething said showing up to work sick poses a risk to co-workers and customers alike. Low-paying that often lack paid sick leave — like cashiers, nail technicians, home health aides, and fast-food workers — involve lots of face-to-face interactions.

“So paid sick leave is about both protecting the public health of a community and providing the workers the economic security that they desperately need when they need to take time away from work,” she said.

The National Federation of Independent Business has opposed mandatory sick leave rules at the state level, arguing that workplaces should have the flexibility to work something out with their employees when they get sick. The group said the cost of paying workers for time off, extra paperwork, and lost productivity burdens small employers.

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According to a report by the National of Economic Research, once these mandates go into effect, employees take, on average, two more sick days a year than before a took effect.

Illinois' paid time off rules went into effect this year. Lauren Pattan is co-owner of the Old Bakery Beer Co. there. Before this year, the craft brewery did not offer paid time off for its hourly employees. Pattan said she supports Illinois' new law but she has to figure out how to pay for it.

“We really try to be respectful of our employees and be a good place to work, and at the same time we get worried about not being able to afford things,” she said.

That could mean customers have to pay more to cover the cost, Pattan said.

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As for Bill Thompson, he wrote an op-ed for the Kansas City Star newspaper about his dental struggles.

“Despite working nearly 40 hours a week, many of my co-workers are homeless,” he wrote. “Without , none of us can afford a doctor or a dentist.”

That op-ed generated attention locally and, in 2018, a dentist in his community donated his time and labor to Thompson's remaining teeth and replace them with dentures. This allowed his mouth to recover from the infections he'd been dealing with for years. , Thompson has a new smile and a job — with paid sick leave — working in food service at a hotel.

In his time, he's been collecting signatures to put an initiative on the November ballot that would guarantee at least five days of earned paid sick leave a year for Missouri workers. Organizers behind the petition said they have enough signatures to take it before the voters.

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——————————
By: Zach Dyer
Title: Paid Sick Leave Sticks After Many Pandemic Protections Vanish
Sourced From: kffhealthnews.org//article/paid-sick-leave-post-pandemic-state-laws/
Published Date: Thu, 09 May 2024 09:00:00 +0000

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