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 Medicaid policies boost oncology clinical trial enrollment for Black and Hispanic patients

 Reviewed

Weill Cornell MedicineJul 25 2024

Two Medicaid policies can interact to increase oncology clinical trial enrollment among Black and Hispanic patients, according to a new study by investigators at Weill Cornell Medicine, the University of Pennsylvania, and Medidata AI. Black and Hispanic patients are historically underrepresented in cancer clinical trials; equitable enrollment helps ensure the knowledge gained from trials generalizes to the entire population and promotes equitable patient access to the latest treatment options.

The study, published July 25 in the Journal of Clinical Oncology, examined the effect of the interaction between two Medicaid policies on the rates of enrollment for Black or Hispanic adults in cancer clinical trials in the United States: Medicaid expansion under the Affordable Care Act (ACA), which extended Medicaid eligibility to more than 20 million residents, leading to greatly improved coverage for people with low income; and pre-existing state-level mandates requiring Medicaid coverage of the routine costs of clinical trial participation.

The study team analyzed deidentified national enrollment data for nearly 50,000 participants in cancer clinical trials from 2012 to 2019 from Medidata's Rave electronic data capture archives. During the study period, only 12 states and the District of Columbia mandated Medicaid coverage of clinical trial costs.

We found that Medicaid expansion under the ACA was associated with about a 5-percentage-point increase in Black or Hispanic patient enrollment in oncology clinical trials in states that had these coverage mandates. We consider this strong evidence that Medicaid is an important policy lever for improving equity in clinical trials in the United States."

Dr. William L. Schpero, co-lead author, assistant professor of population health sciences at Weill Cornell Medicine

The study revealed that Medicaid expansion under the ACA alone was not associated with a statistically significant increase in oncology clinical trial enrollment among Black or Hispanic patients.

"The headline here is that Medicaid expansion by itself did not improve cancer clinical trial diversity; we only saw improvement in those states that already mandated coverage of the routine costs of clinical trial participation," said co-lead author Dr. Samuel U. Takvorian, an assistant professor of hematology-oncology in the Perelman School of Medicine at the University of Pennsylvania. "What we learned, in essence, is that both access and coverage are important for improving accruals of historically underrepresented groups to cancer clinical trials."

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In oncology clinical trials, the cost of the study drug is generally covered by pharmaceutical companies, but the "routine costs of care" -; for example, the cost of administering a new chemotherapeutic agent -; are generally not. Federal law has required coverage of these costs in Medicare since 2000 and in most commercial markets since 2014. It was not until 2022 that all state Medicaid programs were federally mandated to cover the costs as part of the Clinical Treatment Act of 2020.

"One of the biggest factors that determines whether a patient enrolls in a cancer clinical trial is whether their physician recommends it," said Dr. Schpero, who is also co-associate director of the Cornell Center for Health Equity. "Increasing physician awareness of the 2022 federal coverage mandate could help boost enrollment of underrepresented populations in clinical trials."

Source:

Weill Cornell Medicine

Journal reference:

Schpero, W. L., et al. (2024) Association Between State Medicaid Policies and Accrual of Black or Hispanic Patients to Cancer Clinical Trial. Journal of Clinical Oncology. doi.org/10.1200/JCO.23.01149.

Alarming spread of H5N1 bird flu in US dairy cattle reveals cross-species transmission dangers

By Hugo Francisco de SouzaReviewed by Susha Cheriyedath, M.Sc.Jul 25 2024

In a recent study published in the journal Nature, scientists in the United States report the spillover of the highly pathogenic avian influenza (HPAI) H5N1 virus in cattle across several United States (US) regions. They further document the detailed symptomatic outcomes of the resulting disease in these bovine populations. Finally, they use a multidisciplinary approach incorporating epidemiological and genomic analyses to highlight that the virus's evolution confers the ability to allow for not only cow-to-cow transmission but also efficient multidirectional interspecies spillover, infecting birds, domestic cats, and even a raccoon in proximity to diseased cattle.

Study: Spillover of highly pathogenic avian influenza H5N1 virus to dairy cattle. Image Credit: Studio Romantic / Shutterstock

Background

Influenza A virus (IAV) H5Nx is a highly pathogenic avian influenza (HPAI) virus causing widespread respiratory illness and subsequent death in bird populations across Africa, Asia, Europe, and most recently North America. First discovered in China in 1996, the colloquially termed 'bird flu' has since evolved into eight clades and three neuraminidase subtypes, with the H5N1 subtype 2.3.4.4b being its most prevalent and epidemiologically relevant representative.

HPAI H5N1 is alarming, given its potential for spillover (cross-species infectivity). It has been reported to be transmitted from infected poultry populations into wild birds (2002), mammals (domesticated and wild), and even humans (2003). The World Health Organization (WHO) documented 860 human infections and more than 430 deaths since 2003 (fatality rate ~52.8%).

The virus poses significant threats to ecology, economy, and public health, having claimed more than 90 million bird lives in the United States (US) alone. The most recent H5N1-associated morbidity event was that of dairy cattle across Texas (TX), New Mexico (NM), Kansas (KS), and Ohio (OH) between January and March 2024. Understanding the epidemiological and genomic underpinnings of this event may allow researchers to elucidate the etiology (origin) of the disease and prepare for future outbreaks.

Influenza A Virus (H5N1/Bird Flu) Influenza A (H5N1/bird flu) virus particles (round and rod-shaped; red and yellow). Creative composition and colorization/effects by NIAID; transmission electron micrograph imagery is courtesy CDC. Scale has been modified/not to scale. Credit: CDC and NIAID

About the study

The present study documents the January-to-March 2024 morbidity event in American cattle across TX and its neighboring states. It uses a detailed multidisciplinary approach incorporating clinical, epidemiological, and phylogenomic investigations to elucidate the pathophysiology of the virus and the genetic underpinnings of its spillover potential.

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Researchers first obtained samples for the clinic-epidemiological evaluation from nine farms across affected states – TX (5 farms), NM (2), KS (1), and OH (1). Notably, the singular farm in OH was affected following the introduction of cattle (assumed to be healthy) from the first affected TX farm.

Data collection comprised nasal swabs, milk, blood buffy coats, and serum (n = 331). These samples were subjected to real-time reverse-transcriptase polymerase chain reaction (rRT-PCR) and viral metagenomic sequencing. Additionally, tissue from birds (great-tailed grackles, rock pigeons) and mammals (cats and raccoons) found dead at infected farms were subjected to rRT-PCR analysis.

Virus-shedding investigations were conducted to elucidate the source and duration of viral transmissions following initial infections. Excised tissues from cows, dead birds, and mammals were subjected to histological examinations. Finally, phylogenomic analyses were conducted to isolate the etiological source of the viral strain and the genetic underpinnings of its substantial spillover.

Study findings

Clinical-epidemiological investigations revealed multiple disease symptoms in cattle, notably decreased feed intake, mild respiratory distress, reduced rumination time, lethargy, dehydration, abnormal feces, and abnormal milk production (20-100% reduction in quantity, yellow color, and thick consistency). Symptoms persisted for 5-14 days. However, milk production remained reduced for up to four weeks.

All investigated rRT-PCR samples positively detected viral load, but virus shedding was the highest and most frequently detected in milk samples and mammary gland tissue. Notably, while virus shedding duration investigations detected viral loads in milk samples on days 3, 16, and 31 post-infection, infectious virus shedding was only observed on day 3.

"Histological examination of tissues from affected dairy cows revealed marked changes consisting of neutrophilic and lymphoplasmacytic mastitis with prominent effacement of tubuloacinar gland architecture which were filled with neutrophils admixed with cellular debris in multiple lobules in the mammary gland. The most pronounced histological changes in the cat tissues consisted of mild to moderate multi-focal lymphohistiocytic meningoencephalitis with multifocal areas of parenchymal and neuronal necrosis."

Phylogenomic analysis revealed that all recovered viral sequences aligned with a novel monophyletic reassorted substrain of H5N1 termed B3.13, first discovered in a Canada goose in Wyoming (25 January 2024). This lineage was most closely related to a sequence obtained from a deceased skunk in NM (23 February 2024). The similarity between viral genomes from investigated farms highlights circulation and cross-infectivity between their inhabitants, likely due to the transportation and introduction of animals between these farms.

Conclusions

The present study highlights the potential of H5N1 viral spillover and cross-infectivity in both avian and mammalian hosts across farms in the US. The mammary gland was highlighted as the region with the highest viral replication, with infected milk representing the most likely transmission route. The novel substrain (B3.13) identified herein is alarming given its spillover potential (to domestic and wild bird populations and even other mammals – cats, and raccoons).

While no human infections were reported from under-study farms, mild infections were reported during the study duration from other farms near the study area, highlighting the virus's zoonotic potential and the potential for a human pandemic.

Protective Measures

According to guidelines from the CDC, it is crucial to wear the recommended personal protective equipment (PPE) when working directly or closely with sick or dead animals, such as animal feces, litter, raw milk, and other materials that might have the virus. The recommended PPE includes fluid-resistant coveralls, a waterproof apron, a NIOSH-approved respirator (e.g., N95), properly-fitted unvented or indirectly vented safety goggles or a face shield, head cover or hair cover, gloves, and boots.

Proper procedures for putting on and removing PPE, such as washing hands before and after using PPE and disinfecting reusable PPE after every use, are essential. Additionally, it is advised to shower at the end of the work shift, leave all contaminated clothing and equipment at work, and watch for symptoms of illness for ten days after working with potentially sick animals or materials.

Journal reference:

• Caserta, L.C., Frye, E.A., Butt, S.L. et al. Spillover of highly pathogenic avian influenza H5N1 virus to dairy cattle. Nature (2024), DOI – 10.1038/s41586-024-07849-4, https://www.nature.com/articles/s41586-024-07849-4

Written by

Hugo Francisco de Souza

Hugo Francisco de Souza is a scientific writer based in Bangalore, Karnataka, India. His academic passions lie in biogeography, evolutionary biology, and herpetology. He is currently pursuing his Ph.D. from the Centre for Ecological Sciences, Indian Institute of Science, where he studies the origins, dispersal, and speciation of wetland-associated snakes. Hugo has received, amongst others, the DST-INSPIRE fellowship for his doctoral research and the Gold Medal from Pondicherry University for academic excellence during his Masters. His research has been published in high-impact peer-reviewed journals, including PLOS Neglected Tropical Diseases and Systematic Biology. When not working or writing, Hugo can be found consuming copious amounts of anime and manga, composing and making music with his bass guitar, shredding trails on his MTB, playing video games (he prefers the term ‘gaming’), or tinkering with all things tech.

Mass Stranding Involving 146 Dolphins At Cape Cod Declared Largest In US History

Thankfully, rescuers managed to save most of the animals.

LAURA SIMMONS
Editor and Staff Writer
Edited
by Maddy Chapman

JULY 26, 2024

It all began on June 28 with a report of some dolphins stranded in a mudflat near Wellfleet, MA

Amass stranding event involving a total of 146 dolphins on the Cape Cod peninsula in the northeastern United States has officially been declared the largest such event in the country’s history. According to the International Fund for Animal Welfare (IFAW), whose rescuers responded rapidly to the distressed cetaceans, 37 animals died in the event and seven more were humanely euthanized.

On Friday, June 28, IFAW responded to a report of 10 Atlantic white-sided dolphins (Lagenorhynchus acutus) apparently stuck in a shallow mudflat on the shores of Wellfleet, Massachusetts. However, when the team arrived on the scene, it was immediately clear that they were dealing with many more animals than they had thought.

“We arrived to what appeared to be 80 to 100 dolphins on the shallow mud flats of Wellfleet’s Herring River ‘Gut’ – a global epicenter for mass strandings,” said stranding coordinator Misty Niemeyer in a statement. In actuality, the number on that first day quickly rose to 125, the largest stranding that IFAW had seen in its 26-year history in the area.  

“This rescue had many challenges due to the number of dolphins, the large size of many of the animals, how spread out they were over a large area, the difficult mud conditions, and the complicated locations from which we could reach them,” Niemeyer said. In a grueling 12-hour operation, a team of over 150 people from multiple agencies, including 100 trained volunteers, managed to herd most of the animals into safer, deeper waters.

Unfortunately, 10 dolphins had already died by the time the rescuers got to the scene.

The surviving dolphins were carefully herded toward deeper waters.
Image credit: © IFAW

This particular region of coastline is a known risk area for dolphin strandings due to its shape and the strength of the fluctuating tides it sees. IFAW responds to around 315 strandings around Cape Cod every year.

The following morning, June 29, an IFAW team located 10 of the rescued dolphins once again straying into dangerous waters, and 25 more were seen swimming in the shallows just down the coast at Eastham.

Concerns continued into the next day, with a small group of animals being monitored in Wellfleet Harbor and a further stranding of around 20 dolphins in Brewster, MA. Two of them died before rescuers could reach them, but the remainder were saved and moved out to deeper waters.

Overall, thanks to the efforts of the team, 70 percent of the 146 dolphins involved in the incident survived.

As well as those that died of natural causes, the team had to make the decision to humanely euthanize a small number of animals. IFAW’s Deputy Vice President of Rescue Katie Moore explained why this sometimes becomes necessary: “The very social nature of these dolphins means they will stick together even in a bad situation. By removing individuals that are not well, the group may be more easily moved offshore.”

Several weeks later, on July 15, the event was officially declared the largest mass dolphin stranding ever seen in the US.

It’s natural to wonder how and why so many animals could get into difficulties all at the same time. One study has even suggested that, in some cases, an Alzheimer’s-like disease could be to blame, while research into whale strandings suggests that factors within the natural environment are likely to be the main cause. Toxic pollutants and solar storms are other suggestions that have been put forward.  

IFAW reported on July 8 that it is “gathering data to understand what may have caused this mass stranding,” but there are no clear answers yet. Thanks to the coordinated response, tagging data showed that over 100 dolphins had returned to swimming in deeper waters at a safe distance from the shore.  

The multi-day rescue operation saw hundreds of responders coming to the aid of a total of 146 dolphins.
Image credit: © IFAW

If you ever come across a stranded dolphin, it’s important that you don’t try to return it to the sea yourself. Instead, call for help from the experts, like the team at IFAW, and try to keep other people and pets away from the area.

S. KOREA

Medical community outraged over ACRC's decision to penalize doctors, paramedics in Lee Jae-myung transfer case

기자명 Song Soo-youn
Published 2024.07.23 
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The medical community has reacted angrily to the Anti-Corruption and Civil Rights Commission (ACRC)’s decision regarding former Democratic Party of Korea leader Lee Jae-myung's “improper transfer and preferential treatment controversy.”

ACRC said it found no violation with Lee who decided to move from Pusan National University Hospital to Seoul National University Hospital for treatment despite medical professionals’ dissuasion. In contrast, the commission determined that the medical staff and paramedics who treated and transported him violated the regulations.

On Monday, the Anti-Corruption and Civil Rights Commission (ACRC) held a meeting to close the case concerning former Democratic Party of Korea leader Lee Jae-myung for preferential treatment using an emergency medical helicopter, saying there was no violation. On the other hand, it found the doctors who treated Lee and the paramedics who transported him violated the code of conduct. (KBR photo)

On Tuesday, the ACRC held a full-member meeting to close the preferential treatment case against Lee and his secretary, Rep. Chun Joon-ho.

The commission said it decided to close the case because the politicians involved were not subject to the code of conduct and there was insufficient data to determine whether they violated the Anti-Graft Act. The National Assembly’s Code of Conduct applies to public officials other than lawmakers.

“We closed the case against the former opposition leader (Lee) and his secretary because the code of conduct does not apply to lawmakers,” said Jeong Seung-yoon, deputy chairman and secretary-general of the ACRC at a press briefing after the meeting. “We also decided to close the case because there was insufficient data to determine whether the Anti-Graft Act was violated.”

However, regarding the doctors at Pusan National University Hospital and Seoul National University Hospital who provided first aid and treatment to the former representative, and the employees of the Busan Fire and Disaster Headquarters (119 paramedics) who transported him, the statement said, “We have confirmed violations of the Code of Conduct during the transfer from Pusan National University Hospital to Seoul National University Hospital and the use of the 119 emergency medical helicopter, and we have decided to notify the supervisory agencies of each violation.”

The medical community was dumbfounded and outraged. Some said it was a cover-up for the alleged acceptance of luxury bags by First Lady Kim Keon Hee.

“Government authority doesn't just come from browbeating citizens. A situation like this keeps occurring because people who have never lined up for medical treatment at a hospital are making policies,” said Lee Hyung-min, head of the Korean Society of Emergency Medicine, in a telephone interview with Korea Biomedical Review on Tuesday. “Principles are being applied differently, depending on their targets.”

“Like the case of the medical school student increase, too many principles are violated to call something wrong right. In this situation, how can doctors trust the government?” Lee said. “The government has lost its authority. It's a case of the pot calling the kettle black. They should take care of themselves in the future. Don't bring the field of emergency medicine into the mix and make it look bad.”

Lee Kyung-won, director of public affairs at the society, said he could never understand the commission’s conclusion, which blamed doctors and paramedics for violating the code of conduct in transporting Lee using an emergency medical helicopter while finding no problems with Lee’s side.

“The state commission held doctors and paramedics who tried to save the patient accountable while letting off the hook those who requested it (transfer to Seoul National University Hospital) for the reason of insufficient legal grounds,” Lee said, criticizing the ACRC for watching the face of people with power.

Lee added that Pusan National University Hospital, Seoul National University Hospital, and Busan Fire and Disaster Headquarters, notified of the code of conduct violations by the ACRC, might have to take disciplinary action against the doctors and paramedics according to their procedures.

“However, it doesn't make sense that they should be disciplined when all they did was treat an emergency patient and transport him because the patient wanted it,” Lee said. “The government shouldn't do this.”

An emergency medicine specialist said, “After all, the rushed announcement was to cover up the luxury bag scandal, wasn’t it?”.

Lee was attacked in Busan on Jan. 2 when he was the DPK leader and was taken to Pusan National University Hospital, the nearest regional trauma center. However, after completing first aid, he was transferred to Seoul National University Hospital by emergency medical helicopter at around 1 p.m. and underwent surgery there. Pusan National University Hospital said the opposition leader wanted a transfer despite emergency medical experts’ views that it was inappropriate. There were also several reports of preferential treatment during the transfer process.

S. KOREA DOCTORS STRIKE

Professors petition parliamentary probe into ‘why 2000 more medical students’

기자명 Song Soo-youn
Published 2024.07.25 

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A petition has been filed with the National Assembly demanding a parliamentary investigation into the process, by which the decision to increase the medical school enrollment quota by 2,000 was made and implemented.

More than 18,000 people agreed with the petition within a day of its filing.
A petition has been filed to request a parliamentary investigation to determine the truth about the medical school enrollment increase policy. (Source: National Assembly petition website)

On Wednesday, the Medical Professors Association of Korea registered the petition, asking the National Assembly to conduct a probe to find out the truth behind the policy to increase the number of medical school students by 2,000. The petition, titled “Request for a national investigation to find out the truth about the policy to increase the number of medical school seats by 2,000,” has received 18,015 responses as of 10 a.m. Thursday.

The association said that a national investigation should be conducted to make clear the decision-making process for increasing the number of medical school students by 2,000. To do this, it said, the status of the healthcare development plan, the discussion and decision-making process of the medical workforce expert committee, the healthcare policy review committee, the medical issues council, and the minister of health and welfare's decision and implementation of the 2,000 increase should also be clarified.

It added that the process of allocating the 2,000 additional students to each medical school should also be identified. It said that the process of discussing and deciding on the medical school quota allocation committee, determining the number of seats that reflect educational conditions, and deciding on the number of seats for each university should be clarified.

It also argued that the government should scientifically prove the “shortage of 15,000 doctors in 2035,” which it claimed was the basis for increasing medical school students by 2,000. In addition, the association claimed it is necessary to clarify the judicial process for specialties announced by the government, including the order to maintain and open a practice, the order not to accept resignation letters, and the policy not to allow trainee doctors’ return in March 2025.

The association also asked for clarification on the government's policy of prohibiting medical students from taking leave of absence, the Ministry of Education's attempts to infringe on the independence of the Korean Institute of Medical Education and Evaluation (KIMEE), the status of preparing educational conditions for the expansion of medical schools and securing related budgets, measures to prevent doctors and medical students from not returning, and measures to establish a consensus body.

“The government's unprecedented, ultra-fast expansion of 2,000 medical school students, which is unprecedented worldwide, is driving the medical field and medical education into disruption,” the association said. “The National Assembly Health and Welfare Committee hearing in June revealed that the 2,000-student expansion was a ‘three-no policy’ -- no consultation, no basis, and no preparation.’”

The association stressed that the public and the next generation of doctors suffer the most from this reckless policy. It added that university hospitals in the provinces and Seoul have collapsed and cannot accept new medical students for next year. The government is also intimidating the KIMEE and facilitating the deterioration of medical education.

“A parliamentary investigation is needed now to find out the truth about the decision to enroll 2,000 more students and the process of implementation that triggered the crisis to prevent further disruption and find a solution,” the association emphasized.

A separate petition requesting a hearing targeting the Ministry of Education on the medical school student increase policy has been referred to the Assembly’s Education Committee, with 50,000 signatures as of 7 a.m. on Wednesday.

Medical professors boycott recruiting interns for ‘popular’ departments

WHITE, BLUE, PINK THE COLOR OF YOUR COLLAR DOES NOT MATTER WE ARE ALL PROLETARIANS NOW

기자명 Song Soo-youn
Published 2024.07.25 

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Professors are responding to the government's expansion of recruiting trainee doctors for the second half of 2024 with a "boycott" to protest the initiative.

At the Catholic University of Korea College of Medicine, professors at the dermatology and psychiatric departments have issued statements and declared that they would not recruit trainee doctors for the second half of the year, following the example of the radiology and ophthalmology departments.

A growing number of medical professors are refusing to recruit trainee doctors for the second half of this year. (KBR photo)

Catholic Medical Center, which recruits and trains doctors from eight affiliated hospitals, has announced the recruitment of 21 dermatology residents for the second half-year -- six first-year, four second-year, six third-year, and five fourth-year residents.

“The government is not taking responsibility for its misguided policy and is pushing ahead with implementing recruitment for the second half of the year, which could further undermine essential medical care,” the university’s Department of Dermatology said in a statement on Wednesday.

The statement added that the department opposes recruiting trainee doctors and has no intention of implementing it for the second half-year, conveying its position to the Training and Education Department of the Catholic Central Medical Center.

The dermatology professors said they would “refuse all education and guidance” if the recruitment went ahead even though they had no intention of recruiting new residents, let alone those in their senior year. The reason for this stance was to “prevent innocent victims from applying for the second half-year recruitment”

“It’s been more than five months since doctors and students, who could not overlook Korean healthcare’s collapse due to the medical school student increase and the essential care policy package, have given up the positions they have won by working their entire lives,” they said. “We submitted resignation letters in February but the hospital forced us to change our resignations to June 4 to reduce the government's legal liability.”

“If the government was responsible and willing to revive essential medicine, it would never have recruited doctors for the second half of the year while nothing has changed,” they said. “We cannot help but interpret it as the government having a different motive.”

“We will only consider our colleagues and students to be those selected through normal procedures and fair competition,” they said. “We cannot allow someone to usurp the positions of our colleagues through an abnormal and unfair process.”

“We unequivocally reject the Health and Welfare Ministry’s unilateral attempt to fill the positions of resigned trainee doctors with other junior doctors,” they added.

The professors of the Department of Psychiatry at the same medical school also issued a statement on Thursday, opposing the second half-year recruitment of trainee doctors, they would wait for existing residents.

“We oppose this unilateral process,” the psychiatry professors said, calling it “an irresponsible move that removes any clue to problem solving and shifts all responsibility to the frontline faculty and residents.”

“The relationship between faculty and residents in a training hospital is the sum of formal and informal processes that are integrated and intensive with the goal of training specialists in the field,” the psychiatry professors said. “The selection and training of residents is a long process involving many faculty and residents. We cannot accept unilateral actions that seek to alter this status quo artificially.”

“The residents who have submitted their resignations in protest of the medical school's recruitment policy are members of the Department of Psychiatry and should be protected from any unwanted disadvantages or changes in their status,” they said. “We oppose the government's unjustified resignation process and the unilateral initiation of the recruitment process for the second half-year. We will continue to persevere and work to ensure that the current residents in this class can continue their training at the Catholic University of Korea School of Psychiatry.”

Yonsei University College of Medicine professors have also announced their intention to boycott training for interns, calling for the Big Six hospitals to stop recruiting trainee doctors for the second half-year.

Oriental medicine leader calls for ‘leveling the playing field’ in health policies

기자명 Kim Eun-young
Published 2024.07.24 
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Oriental medicine doctors are also important stakeholders in the government’s policy to increase the medical school enrollment quota, their leader said Tuesday.

He also pointed out that medical policies are centered on Western medicine, vowing to expand the scope of oriental medicine to “normalize the tilted playing field.”

On Tuesday, Yoon Sung-chan, president of the Association of Korean Medicine, called for applying actual loss insurance to unreimbursed oriental medicine practices and reimbursing the use of diagnostic devices by oriental doctors in a news conference to mark his 100th day in office at the association headquarters in Seoul. (Courtesy of the Association of Korean Medicine)

Yoon Sung-chan, president of the Association of Korean Medicine, made these and other points at a press conference to mark his 100th day in office at the association headquarters in Gayang-dong, southwestern Seoul.

“Unfortunately, the discussions at the presidential committee on healthcare reform seem to focus only on institutional improvements to bring back doctors,” Yoon said. “I have insisted that the oriental medicine community also participate and discuss the big picture of healthcare reform.”

Yoon noted that many healthcare system improvements discussed now are possible only with astronomical financial resources.

“To maintain a sustainable healthcare system in this era of population aging, we need adequate medical care and fees, and the country can increase (system) sustainability by promoting oriental medicine,” he emphasized.

“We are not asking the government to give preferential treatment to traditional medicine practitioners,” Yoon said, ”We are asking it to level the playing field so that we can compete fairly. Please understand the difficulties of oriental medicine practitioners.”

To normalize the tilted playing field, Yoon called for “applying actual loss compensation insurance to unreimbursed oriental medicine practices” and “reimbursing the use of diagnostic devices by oriental medicine doctors.”

According to Yoon, excluding non-reimbursed medical expenses for oriental medicine from the second generation of actual loss insurance in October 2009 led to a decline in the number of patients visiting oriental medicine clinics since 2014.

Although the Anti-Corruption & Civil Rights Commission issued a recommendation in July 2014 to include unreimbursed medical expenses for therapeutic oriental medicine in accidental loss insurance, the situation has not improved.

“One of the most unfair aspects of the healthcare system is the lack of coverage for unreimbursed oriental medicine practices by actual loss insurance,” Yoon said, emphasizing, “It was one of my campaign promises when I ran for the association’s leader, and I will accomplish it before leaving office by all means.”

“Oriental medicine and Western medicine compete for patients with the same diseases. It is unfair that Western doctors get coverage for unreimbursed practices while oriental medicine practitioners do not,” he said. “We can guarantee people's right to choose medical treatment and resolve medical distortions, such as unfair medical market and excessive non-reimbursed treatments caused by monopolies.”

“We are not asking for actual loss insurance coverage to be applied to herbal tonics. We're asking for oriental medicines, acupuncture, and chiropractic with a clear therapeutic purpose,” Yoon said. “Excluding herbal tonics, medical expenses are not expensive, either. Going in this direction is more helpful to create a sustainable medical system.”

He also urged the government to cover the use of diagnostic devices by oriental medicine doctors.

Although the Constitutional Court has ruled that tonometers, auto-refractors, slit lamp microscopes, automatic vision measuring equipment, and audiometers are not illegal for use by oriental medicine doctors, and the use of blood and urine tests, ultrasound diagnostic devices, in vitro diagnostic kits, and electroencephalographs are all legal according to the Health and Welfare authoritative interpretation and court rulings, it is still difficult to cover oriental medicine doctors' use of diagnostic devices, he noted.

“To respond effectively to the medical vacuum caused by repeated doctor strikes, it is essential to reimburse the use of diagnostic devices by oriental medicine doctors,” Yoon said. “Reimbursing the use of diagnostic devices by oriental medicine doctors will reduce the inconvenience of double visits to medical institutions, reduce medical costs, increase treatment efficiency, and revitalize the medical device industry.”

In addition, Yoon called for the government to allow the participation of oriental medicine doctors in the government's policies to strengthen primary healthcare, including the pilot project on the number of visits by oriental medicine doctors in primary healthcare, a pilot project on oriental dementia doctors, a pilot project on health doctors for the disabled, and a pilot project on chronic disease management in primary healthcare.

“Several pilot projects are being promoted under the government's policy of revitalizing primary healthcare, but oriental medicine has been excluded,” Yoon said. “It should be designed as a pilot project that oriental medicine doctors can participate in, but (these discussions) have been blocked. The government should include oriental medicine doctors in the pilot project to ensure people's right to healthcare choice and help improve health.”

Confusion worsens as government accepts medical exam applications despite student boycott

기자명 Kim Ju-yeon
Published 2024.07.23 
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The government has begun the registration process for the medical practical examination as students boycott classes and exams in protest of the medical school enrollment quota increase, adding to the confusion in the education field.

Medical students think there is no reason to take the national exam while the controversy remains unresolved. Professors say there is no way to reverse the students' decision, doubting that students can properly prepare for the exam even if they take the extra test, given the disruption in medical education.

Although the practical examination for the national medical licensing examination has begun, most prospective medical graduates still refuse to take the exam, adding to the confusion in the medical education field. (Source: Korea Health Personnel Licensing Examination Institute)

The Korea Healthcare Personnel Licensing Examination Institute accepts applications for the practical examination for doctors from Monday to Friday. The practical exam will be held over three months, from Sept. 2 to Nov. 4.

However, the number of examinees will likely drop significantly, as most medical school graduating students have declared their refusal to take the exam.

According to a survey conducted by the Korean Medical Student Association on 3,015 fourth-year students from 40 medical schools nationwide, 2,903 respondents, or 95.52 percent, refused to submit a consent form to provide personal information for the test.

Under the Medical Service Act, students expected to graduate medical school within six months are eligible for the test. So far, medical schools have submitted a list of graduating students to the institute after winning medical students’ consent to provide personal information to prove they are eligible.

This year, however, medical students did not submit the consent form to the medical school, and the list of intended graduates could not be handed over, making it impossible for them to take the exam.

Medical students say there is no reason to take the national exam unless the government resolves the causes of the problem, i.e., increasing the number of medical students. They also say it is impossible to practice properly due to the absence of senior trainee doctors in training hospitals.

“One of the main methods for medical training is apprenticeship training taught by seniors,” said a fourth-year medical student who took a leave of absence from a medical school in South Gyeongsang Province, in a telephone interview with Korea Biomedical Review on Monday. “Even if we take the national exam and get a license, there are no senior doctors to teach us at the training hospital.”

“It's not just a matter of seniors and juniors. Mixing trainers and trainees leads to a deformed training system, and training hospitals cannot accommodate all graduates. It will eventually accelerate the brain drain to the beauty sector,” he said.

The student continued, “Medical students are not asking for an immediate fix for not taking the national anthem and not finishing their practicum hours and internships,” emphasizing that the way to solve the problem is to understand the cause, not to hide the effect of the wrong policy.

Medical school professors say they are “frustrated” by the situation but recognize that it is up to the students.

“Currently, none of the fourth-year students have submitted their personal information,” said a professor at a provincial university hospital. “The dean is trying to persuade them, but it's useless because they are so firm in their stance. It's frustrating but we can't do anything.”

A professor at a Seoul-based medical college also said, “I'm worried, but I think the students are adults and will make their own decisions.”

Professors believed medical students who stay in school for one reason or another would find it difficult to prepare for the national exam in the absence of proper education.

“Eight fourth-year students remain in school but I am not sure if they will be able to prepare properly for the exam in the current situation,” another Seoul-based medical school professor said. “Before the exam, a consortium of several medical schools holds a mock Clinical Performance Examination (CPX) but this year we could not do it.”

She continued, “There are private CPX schools demanding millions of won so they might prepare somehow. However, most of the remaining fourth-year students have flunked several times and can no longer take time off from school. They don't have a peer group to study with. How can they properly prepare for the exam in such a confusing situation?”

As announced by the Ministry of Education earlier, there is a possibility of holding an additional medical national examination. However, even if medical students return, they must resolve the academic management first, as fourth-year students will not be eligible to take the national exam if they do not graduate this year.

“When the students return, the government has no choice but to allow them to take additional exams. But we don't know when they will return, and even if they do, how can they sit for the exam if they haven't completed their fourth year of school?” the professor asked.

She continued, “Fourth-year students don't have a lot of curriculum, so I'm sure they can somehow fit in the number of class days. In principle, however, it doesn’t make sense to let them graduate when they haven't met the standards.”

The medical student in South Gyeongsang Province said that even if he were allowed to take additional exams, he was not confident that he would be able to prepare properly, given the disruption in medical education over the past six to seven months.

“I am skeptical that I will be able to pass the practical exam since I have not practiced clinical skills (OSCE) and CPX at all,” he said. “Even if I can take the exam, many think it will be difficult to prepare for it while combining clinical practice and skill study for the rest of the year, making it difficult to pass.”

Meanwhile, the state institute said that if students agree to provide their personal information during the application period and are registered as graduate students, they can apply for the practical exam. It added that they will prepare for the practical exam regardless of the number of applicants.

“Except for medical school graduates who failed to submit the personal information consent form, medical school graduates can take the practical examination,” an institute official said. “However, if they register with the institute as a graduate through their medical school within the registration period, they can take the practical examination. It would be good for medical schools to spread this information.”

The official continued, “Depending on the number of candidates, the overall test period or schedule may be adjusted. However, once the registration is complete, we plan to proceed with the exam as normal regardless of the number of candidates, and we are currently preparing for this.”

S.KOREA

Medical community condemns re-proposed assisted dying bill, citing ethical violations

REACTIONARIES

기자명 Kim Ju-yeon
Published 2024.07.25 
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The re-proposed “Assisted Dying with Dignity Act,” which would allow patients with no hope of recovery to end their lives with physicians’ help, has been met with a backlash from the medical community.

Doctors argued that assisted dying does not promote patient self-determination and undermines physicians' professional ethics, which prohibit assisting suicide.

The medical community opposed the bill to allow assisted dying for terminally ill patients. (Credit: Getty Images)

“A bill that attempts to turn doctors into a tool for assisted suicide (euthanasia), although doctors are the ones who care for patients' suffering and enable them to live a dignified life until the day they die, can never help patients or the public die with dignity,” the Medical Ethics Research Society said in a statement on Wednesday.

“In countries where assisted suicide is legalized, adverse effects have occurred, including the recommendation of assisted suicide to depressed patients who are seeking treatment for suicidal thoughts,” the group said. “There were even amendments to the law to allow assisted suicide for people who are not terminally ill but claim to be suffering from life's pain, adolescents, and children.”

“We oppose the proposal that infringes on patients' right to self-determination and undermines medical ethics,” the group said, calling for the bill to be scrapped and a practical plan for the care of terminally ill patients to be developed.

“The medical ethics code strictly prohibits doctors from assisting or participating in a patient's suicide,” the organization said. “Prescribing and injecting suicide drugs to a patient under their care is a serious ethical violation that undermines the identity of a doctor as a healer. Immediately repeal this bill that undermines the professional ethics of physicians.”

The group said assisted suicide also does not guarantee patients' right to self-determination.

“The right to self-determination should not harm others. However, the practice of end-of-life self-determination is an unethical act that hurts and harms both the family and those around them,” it said. “If enacted, the law could lead to tragedies where doctors misinterpret a patient's plea of ‘I'm sick and would rather die’ as self-determination, leading to the patient's death.”

Fear of burdening family members with excessive care costs and worry that they will not receive dignified care can drive patients to consider assisted suicide, the organization said, calling for more hospice facilities and staffing to care for terminally ill patients.

“We urge lawmakers to recognize the needs of all people who will be facing the end of their lives,” the organization said. “Assisted suicide is never a way to preserve the dignity of life. Please do your best to prepare a system for dignified care at the end of life.”

Earlier, Rep. Ahn Kyu-baek of the Democratic Party of Korea introduced the bill for “Assisted Dying with Dignity Act” on July 5, which allows terminally ill patients to die with dignity based on the deliberations and decisions of the Assisted Dying with Dignity Decision Committee.

Ahn introduced a similar bill in June 2022 but it was abandoned due to the expiration of the 21st National Assembly's term.

S. KOREA

Average monthly anesthesia hours per anesthesiologist increased in 2 years

WHITE, BLUE, PINK THE COLOR OF YOUR COLLAR DOES NOT MATTER WE ARE ALL PROLETARIANS NOW

기자명 Kwak Sung-sun
Published 2024.07.26 

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The average monthly anesthesia time for one anesthesiologist has increased by nearly four hours in two years, and the average monthly anesthesia time for anesthesiologists at special hospitals was about 20 hours longer than that of tertiary general hospitals.

The Health Insurance Review and Assessment Service (HIRA) released the “Third Anesthesia Adequacy Evaluation” results on Friday.

The third round of anesthesia appropriateness assessments showed an increase in Grade 1 institutions and a decrease in Grade 5 institutions compared to the second round. (Credit: Getty Images)

The agency has conducted anesthesia adequacy assessments since 2018 to improve medical quality in anesthesia and lay the foundation for the safety management of anesthesia patients. As the need for anesthesia safety management in small- and medium-sized hospitals was raised, the evaluation target was expanded to specialized hospitals in the second evaluation and all hospitals in this third evaluation.

The result showed the average monthly anesthesia time per anesthesiologist was 153.4 hours, an increase of 3.6 hours from 149.8 hours in the second evaluation. Special hospitals showed the highest average monthly anesthesia time per anesthesiologist at 203.5 hours. That compared with 178.6 hours in tertiary general hospitals and 127.4 hours in general hospitals.

Regarding the enhanced indicator of “availability of a recovery room,” 282 hospitals, 67.8 percent of the total, met the standard.

Rates of pre-anesthesia patient assessments, nausea and vomiting in the recovery room, and pain scoring were similar to the secondary assessment.

Pre-anesthesia patient assessment rates averaged 96.6 percent, and rates of nausea and vomiting and pain scoring in the recovery room averaged 96.4 percent, an increase of 1.2 percentage points from 95.2 percent at the second assessment.

Besides, the share of patients maintaining normal body temperature (35.5℃ or higher) during and after anesthesia improved from the second evaluation in all types of hospitals, tertiary general hospitals, general hospitals, and special hospitals. In particular, the share at special hospitals improved by 22.7 percentage points from 65.2 percent to 87.9 percent in the third evaluation.

The overall score averaged 89.7 points, an improvement of 2.3 points from the second evaluation. By type, general hospitals improved by 3.0 points and special hospitals by 2.5 points.

The anesthesia appropriateness assessment was divided into 1-5 grades based on the overall score to make it easier for the public to understand, and the share of Grade 1 institutions was 54.9 percent, an increase of 3.7 percentage points from the second assessment. In contrast, that of Grade 5 institutions decreased by 2.7 percentage points.

There were 219 Grade 1 institutions, distributed relatively evenly across all regions, including 62 in the Gyeongsang region, 56 in the Gyeonggi-Incheon region, and 46 in the Seoul region.

The overall hospital-level composite score averaged 48.5 points, lower than other categories. Considering it was the first assessment of hospital-level institutions, HIRA released only the national results.

“The results of the anesthesia appropriateness assessment have improved overall, and we are positive about the efforts of special hospitals to improve anesthesia patient safety management,” said Jeon Mi-joo, head of the HIRA’s Evaluation Operation Office.

To improve the quality of medical care in hospitals that have been expanded to the third round of the assessment, HIRA will improve evaluation criteria and indicators, considering each type of hospital and actively support hospital-specific quality improvement activities, Jeon added.

S. KOREA

4-day workweek reduced turnover and increased quality: Severance Hospital

기자명 Kim Ju-yeon
Published 2024.07.24 

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Yonsei University Health System’s “four-day workweek experiment,” the first of its kind among medical institutions, has produced positive results in reducing nurse turnover and increasing job satisfaction.

However, there were many obstacles to overcome, including securing the financial resources needed to hire more staff, before the program could be established as a system rather than a pilot project, according to the hospital group’s labor union.

On Tuesday, the Severance Hospital Labor Union held a briefing session on “Results and Implications of the One-Year Four-Day Workweek Pilot Project at the National Assembly Library. (KBR photo)

On Tuesday, the Severance Hospital Labor Union held a briefing session on “Results and Implications of the Four-Day Workweek Pilot Project” at the National Assembly Library. It was the second report after the interim report session on Oct. 11 last year when the union released the interim results of the four-day workweek pilot project.

The labor and management of Severance Hospital agreed on Aug. 8, 2022, to implement a four-day week pilot project for one year from January to December 2023, divided into the first and second halves, through a collective agreement. Last year, five nurses were selected from Wards 171-172 of Severance Hospital and Ward 83 of Gangnam Severance Hospital, with 30 nurses participating in the four-day pilot project.

By agreeing to extend the four-day workweek pilot project by one year and expand the participating wards this year, the project is in its second year.

At the briefing, the survey results conducted on 30 nurses who participated in the pilot project last year were revealed.

Kim Jong-jin, head of the Korea Worker Institute-Union Center, who participated in the research, explained the results of the four-day workweek pilot project in 2023. (KBR photo)

Kim Jong-jin, head of the Korea Worker Institute-Union Center, who participated in the research, said that the nurses who participated in the four-day workweek pilot project experienced increased job satisfaction, leading to a reduced turnover rate and improved quality of nursing services.

According to the study, the turnover rate in the wards that implemented the four-day week has decreased significantly compared to 2022. In 2022, Ward 171 had a turnover rate of 3.6 percent, which fell to 0 percent in 2023. Ward 172 also saw its turnover rate drop to 2.6 percent. At Ward 83, the rate decreased from 27.0 percent in 2022 to 18.2 percent in 2023.

The number of kindnesses rated by patients also increased. Ward 171 increased from 85 kind services in 2022 to 132 in 2023, and Ward 172 increased from 42 to 111. However, Ward 83 marked a decrease from 74 to 70 acts of kindness. At Wards 141 and 81, the number of acts of kindness increased from 80 to 93 and from 39 to 46, too, but the increase was greater on units with a four-day week.

Nurses on the four-day week felt that the quality of care was improving.

When comparing the results of the first survey, conducted in December 2022 before the pilot began, to the fourth survey, conducted in December 2023 after the pilot was completed in the second half of the year, the score for the item “The risk of medical and safety incidents is increasing” decreased from 69.6 in the first survey to 59.3 in the fourth survey. For the item “Friendliness toward users is increasing,” the score increased from 55.2 in the first round to 60.2 in the fourth round. For the item “The quality of medical and counseling services provided to users is improving,” the score increased from 56.7 in the first round to 63.8 in the fourth round, an increase of 7.1 points.

They reported a significant increase in job satisfaction and a turnover intention decrease. On a 100-point job satisfaction scale, the highest score for four-day workers was 65.2, while the highest score for five-day workers was 52.7, a difference of 12.5 points. And while only 18.7 percent of four-day workers would consider changing jobs, the number jumped to 68.2 percent of five-day workers.

The increased number of days off also improved nurses' health.

When asked about absenteeism when an employee misses work due to sick leave or other reasons, the absenteeism rate dropped from 10.0% in the first survey to 8.3 percent in the fourth survey. Presenteeism, which refers to coming to work while sick and being less productive, also dropped from 86.4 percent in the first survey to 68.2 percent in the fourth.

Besides, the percentage of nurses working four days a week who suffered from sleep disorders, depression, musculoskeletal disorders, disks, cystitis, plantar fasciitis, and other related conditions also decreased.

Kim emphasized that a four-day workweek can reduce unnecessary costs.

“We need to institutionalize pilot projects, such as the four-day workweek, to improve the health, work-life balance, job satisfaction, and turnover of hospital nurses,” Kim said. “If the turnover rate of new nurses decreases, the cost of investing in education and training will also decrease. It also reduces unemployment benefits. This will improve nurses' work-life balance and reduce social and economic costs.”

“Based on Articles 11 and 4 of the Healthcare Workforce Support Act, the government must support efforts to secure adequate working hours and improve working conditions. As there is a provision for this, relevant government ministries should take steps to expand the four-day week pilot project,” he added.

Kwon Mi-kyung, leader of the Severance Hospital Labor Union, said she will work to expand the four-day workweek pilot project to other hospitals. (KBR photo)

Professor Jang Soong-nang of Chung-Ang University College of Nursing, who also participated in the panel, advised on what other hospitals should consider when implementing a four-day week pilot project.

“For the management, money is bound to be a priority as implementing a four-day workweek requires staff recruitment,” Professor Jang said. “In addition, there may be concerns that patient care may be neglected as working hours are reduced.”

“We need to study the necessity of a four-day workweek by thoroughly analyzing current issues and overseas cases,” she said. “We also need to review legal regulations, including whether a new law is needed to implement a four-day workweek. It is also recommended to organize evidence to refute concerns that the four-day workweek may cause costs due to the division of duties among nurses and scheduling.”

Severance Hospital Labor Union leader Kwon Mi-kyung said, “The medical center is still skeptical about the manpower and effectiveness of the four-day week pilot project. However, the labor and management decided to conduct the pilot project because they agreed it would reduce nurses’ turnover.”

“I know that other unions are concerned about wage cuts, but we agreed to a 10 percent cut in our existing wages because it could be misunderstood as a favoritism compared to other employees,” Kwon said. “The union's goal is a four-day workweek without wage cuts and we will work to expand it to all Severance Hospital employees and other hospitals, and to get the government's attention.”

Park Hye-rin, director of the Nursing Policy Division at the Ministry of Health and Welfare, said specific performance indicators for the four-day week pilot program are needed to demand the government’s support. (KBR photo)

The government said that the pilot program needs to show objective indicators improving employee satisfaction and patient health to demand the government’s support for its expansion.

“We need concrete data to support this, not just subjective results that participants’ remarks that they could provide better services,” said Park Hye-rin, head of the Nursing Policy Division at the Ministry of Health and Welfare. “Developing concrete indicators, such as the number of patient safety incidents and the extent to which patients’ medical expenses were reduced after the pilot project, will help the government expand and implement the pilot project.”

“The government supports the expansion of manpower for the pilot project to improve the nurse shift system. However, a four-day workweek is impossible with the labor costs supported by the shift system pilot project,” she said. “Health insurance is a financial source for supporting people's health, so we need to accumulate indicators that prove it helps people's health.”

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S. KOREA

Wuxi AppTec, WuXi Biologics boost lobbying spending amid rising US security concerns

기자명 Kim Ji-hye
Published 2024.07.24 

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A record of $4.2 billion was funneled into influencing U.S. federal lawmakers in 2023, and the pharmaceutical and health products industries were the leading contributors, industry data showed.

On Tuesday, the Korea Biotechnology Industry Organization (KoreaBIO), a representative organization in the bioindustry field in Korea, released a report on Tuesday, citing data from the D.C.-based nonprofit OpenSecrets, which tracks money in politics.

According to the OpenSecrets analysis, “health companies spent more than any other sector in 2023 with U.S. federal lobbying spending topping $739 million for the year.”

 

U.S. health companies led all sectors in 2023 federal lobbying, with spending soaring to $739 million. (Source: OpenSecrets analysis of Lobbying Disclosure Act filings in 2023)

Among the key players are WuXi Biologics and its parent company, WuXi AppTec, two of China's largest contract research development and manufacturing organization (CDMO) giants. Their lobbying expenditures have soared, driven by the looming threat of the U.S. Biosecure Act.

The Biosecure Act is designed to safeguard national security by prohibiting certain U.S. government agencies from sourcing equipment or services with so-called “biotechnologies of concern,” like WuXi AppTec and WuXi Biologics, due to fears that the People's Liberation Army (PLA) could exploit their technology for military purposes.

“The legislation reflects deep-seated concerns about civilian tech advancing military capabilities and China's growing competitiveness in biotechnology,” said Oh Ki-hwan, senior managing director of the industry policy division at KoreaBIO.

However, the Biosecure Act missed its first chance at a congressional ride when the House Rules Committee omitted it from the 2025 National Defense Authorization Act (NDAA) annual spending bill. Despite its exclusion from the NDAA, House Speaker Mike Johnson (R-LA) assured that he would push the bill to the floor in the Fall. On July 8, in a speech at the Hudson Institute, a conservative think tank, Johnson emphasized the Biosecure Act among his top China-related legislative priorities.

The bill is on a fast track through U.S. Congress, with bipartisan support propelling it toward law, said Oh. "Johnson has made it clear that the bill is expected to pass, regardless of which party is in power after the 2024 U.S. Congressional and Presidential elections."

The stakes are high, the battle lines are drawn, and the pharmaceutical industry is in a frenzy to counteract the threat.

A record $4.2 billion was poured into federal lobbying last year, led by the pharmaceutical and health sectors, with key players like WuXi AppTec and WuXi Biologics boosting their spending dramatically in response to the looming Biosecure Act. (Credit: Getty Images)

KoreaBIO said that based on the Lobbying Disclosure Act (LDA) Reports, WuXi AppTec’s lobbying expenditures jumped from $100,000 in the fourth quarter of 2023 to $360,000 in the second quarter of 2024.

WuXi Biologics isn’t far behind, increasing its lobbying budget from $40,000 in the third quarter of 2023 to $165,000 by the second quarter of 2024, according to KoreaBIO.

With WuXi AppTec and WuXi Biologics targeted in the Biosecure Act, U.S. companies will be rocked, and WuXi AppTec and WuXi Biologics’ revenues will likely plummet, given that a majority of its business is conducted with U.S. companies, said Oh. He said that global consulting firm L.E.K. Consulting’s survey results revealed that global life science companies’ trust in Chinese companies has significantly declined, particularly in the CDMO sector, prompting many to take precautionary measures.

After a U.S.-based Biotechnology Innovation Organization (BIO) survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, the bill’s new draft laid out a 2032 deadline for U.S. firms to sever ties with high-risk Chinese biotechnology companies as well as their subsidiaries, parents, affiliates, and successors. Oh said companies are now eyeing alternatives like Indian pharmaceutical CDMOs to avoid risks that could hinder their entry into the U.S. market.

Major global biologics manufacturers are fueling the surge in pharmaceutical lobbying, driven by intense scrutiny of prescription drug benefit managers (PBMs), which are seen as major obstacles to lowering drug prices. The battle to keep drug prices high and protect profit margins is fierce. “PBMs resist change, intensifying governmental pressure to lower drug prices by targeting these organizations,” Oh said.

The health sector remains a top spender at both the federal and state levels,continuing a trend that started in 2019, according to OpenSecrets. As scrutiny intensifies around prescription drug management and regulatory issues, spending is expected to soar even higher in the coming months. With the spotlight on biosafety legislation, biotech and pharmaceutical companies are poised to escalate their lobbying efforts further.

“The pharmaceutical industry is set to once again dominate lobbying expenditures this year,” said Oh.