Naval Medical Research Center Begins Phase 1 Testing of Diarrhea Vaccine

Naval Medical Research Center Begins Phase 1 Testing of Diarrhea Vaccine
Dr. Frederic Poly and Dr. Renee Laird, study experts with Naval Health-related Investigation Center (NMRC), pose for a picture in the Enteric Illnesses laboratory. NMRC’s Enteric Health conditions Department, led by Poly, have partnered with the National Institute of Health’s Countrywide Institute of Allergy and Infectious Health conditions to begin phase 1 tests of a new vaccine for Campylobacter jejuni, a foodborne pathogen. U.S. NAVY / Michael Wilson

SILVER SPRING, Md. — Scientists with Naval Professional medical Analysis Centre (NMRC)’s Enteric Illnesses Department have partnered with the Nationwide Institute of Health’s National Institute of Allergy and Infectious Diseases to start off phase 1 tests of a new Campylobacter jejuni vaccine, NMRC introduced in a Dec. 19 release. 
 
Campylobacter jejuni, a foodborne pathogen, is one particular of the most widespread results in of diarrheal health issues in the U.S. and abroad, and can influence readiness of deployed or touring services associates. 
 
Stage 1 tests, at the moment underway at Cincinnati Children’s Healthcare facility Clinical Center, focuses on the security and finest signifies of Campylobacter vaccine shipping. Scientists will vaccinate 60 patients in total as section of Phase 1 tests. This very first phase of screening is predicted to proceed by the conclude of 2023. 
 
Stage 2 tests will include vaccinating groups of grown ups with a dose of the vaccine identified in stage 1, to ascertain its effectiveness in protecting against Campylobacter. NMRC scientists anticipate to get started period 2 screening by 2025 at the earliest, based on funding and the facilities out there. 
 
Diarrhea is a regularly transpiring disease throughout armed service functions, even with modern preventive medicine efforts. The affect of serious diarrhea can be debilitating and impair a assistance member’s capacity to do their position. Acute diarrheal disease for the duration of deployment is normally accountable for reduction of obligation times, negatively has an effect on mission readiness and may well be lethal in the worst situations. 
 
“With genuinely infectious diarrhea, you get cramping, and if you have cramps, you simply cannot definitely function,” mentioned Dr. Frederic Poly, head of NMRC’s Enteric Illnesses Section, who has been associated with the venture since 2005. “You can acquire a fever you’re going to get dehydrated and you’re heading to get rid of cognitive perception. These are all indications that will negatively influence how you function.” 
 
Next recovery from original an infection and bouts of diarrhea, people today can nonetheless working experience very long-term results of infection. 
 
“With Campylobacter, there’s potential downstream effects, like irritable bowel syndrome or Guillain-Barré syndrome, which can lead to respiratory and neurological concerns,” observed Lt. Yuliya Johnson, a microbiologist with NMRC. “It does not materialize to every person, but there is still an linked threat we hope to mitigate by establishing a vaccine.” 
 
According to Poly, this vaccine will be the initial created for use against Campylobacter, and if successful, has the prospective to profit civilian and pediatric populations as nicely. Vaccination at a youthful age can control developmental problems brought about by diarrhea that may well otherwise have an effect on physical and psychological progress in kids. 
 
Poly, NMRC’s most new senior civilian of the quarter for science, prospects the NMRC Enteric Disorders Department. The division, composed of 23 full time microbiologists, molecular biologists, biochemists and immunologists, researches treatment plans for the prevention of infectious bacterial diarrhea. 
 
This past 12 months, the section concluded advancement and medical evaluation of a prophylactic against a further navy suitable enteric pathogen, ETEC (enterotoxigenic E. coli). The enteric disorders lab is also working on the improvement of an oral prophylactic to protect against an infection from several other intestinal pathogens. 
 
NMRC and its instructions are engaged in a wide spectrum of exercise from simple science in the laboratory to area scientific studies in austere and remote parts of the environment to investigations in operational environments. In help of the Navy, Maritime Corps and joint U.S. warfighters, researchers review infectious diseases, organic warfare detection and protection, battle casualty care, environmental health and fitness fears, aerospace and undersea drugs, professional medical modeling, simulation, operational mission aid, epidemiology and behavioral sciences. 

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Dementia, stem cell, and mental health research

2022 has been an eventful year when it comes to medical research, but what are some of the most intriguing findings and trends? Our editors, Maria Cohut, Yasemin Nicola Sakay, and James McIntosh reflect on this year’s highlights in our December “In Conversation” episode.

While 2020 and 2021 may have stuck in the collective memory as two intense pandemic years, 2022 has also been an eventful one.

Google’s Year in Search report pinpoints some of people’s most pressing concerns at a global scale throughout 2022. One of these is the monkeypox epidemic, which the World Health Organization (WHO) declared a “public health emergency of international concern” in August.

The death of Queen Elizabeth II of Great Britain in September, after a record 70-year reign, garnered global interest, as did the impact of the ongoing conflict in Ukraine.

And the overturning of Roe v. Wade in the United States sparked concern among medical communities worldwide.

But 2022 has also seen a wealth of advances in medical research, from a new way of assessing potential dementia symptoms that may help to diagnose it up to 9 years sooner than the current standard to the discovery of an insulin-mimicking molecule that may, in the future, help treat diabetes.

This December, three of our editors — myself, the Feature Editor, Yasemin Nicola Sakay, the Global News Editor, and Managing Editor James McIntosh — joined the “In Conversation” podcast to talk about some of 2022’s research highlights.

These include the twists and turns dementia research has taken this year, why scientists are increasingly interested in the potential of psychedelics in mental health treatments, and how stem cell research is advancing at a steady pace.

Listen to this month’s installment of our podcast below, or on your preferred streaming platform.

This year has been a very charged one for dementia research. As many as 55 million people around the world live with a form of dementia, the most common form of which is Alzheimer’s disease.

While there are some treatments that target symptoms of dementia, such as memory loss and anxiety, there is currently no cure for Alzheimer’s disease and related neurodegenerative conditions.

One thing that would help researchers find better treatments to prevent or slow down the progression of dementia symptoms would be finding out its true cause and the mechanisms that drive it.

The ‘amyloid hypothesis’ controversy

In 2006, a study that appeared in the journal Nature lent credibility to what is now known as the “amyloid hypothesis,” which holds that an overaccumulation of beta-amyloid protein in the brain — forming sticky amyloid plaques — disrupts the communication between neurons, thus being largely responsible for the main symptoms of dementia, such as memory and thinking problems.

Since its publication, the Nature paper has been cited in over 2,200 other studies, and the amyloid hypothesis has informed the vast majority of the dementia research conducted until now.

Yet in July 2022, an assistant professor of neurology at Vanderbilt University called into question claimed that some of the images in the seminal study had been manipulated, which may affect the credibility of the amyloid theory.

While the 2006 Nature paper has not, at the time of writing, been retracted, the recent claims of scientific misconduct have caused an uproar among dementia experts, and given rise to many questions.

One question is: If the paper truly does build on inaccuracies, will this invalidate some of the findings in dementia research reported until now? Not so, some experts say.

Speaking to Medical News Today, Dr. Sara Imarisio, head of research at Alzheimer’s Research UK, explained that “the findings from the [Nature] paper were very specific and, contrary to some reports, have not significantly affected the progress or direction of research into Alzheimer’s.”

“Even for research groups who work in this particular area, findings that can’t be reproduced will be identified as controversial and lose credibility, while genuine findings will come to predominate and guide the direction of future studies.”

– Dr. Sara Imarisio

Indeed, some findings about amyloid plaques seem to hold true, as a recently developed drug, lecanemab, which attacks the accumulation of beta-amyloid in the brain, has shown clear promise in recent clinical trials, and its developers hope that the drug will be approved for use in people aged 65 years and older in the U.S. as soon as next year.

New research avenues

But scientists were already aware that beta-amyloid plaques are not the be-all and end-all of dementia research. How so? In our June 2022 podcast, we spoke with Dr. Kamar Ameen-Ali, a lecturer in biomedical science at Teesside University in the United Kingdom.

Dr. Ameen-Ali explained that the crux of the matter is this: Beta-amyloid accumulates in the brains of healthy people just as it does in those of people with dementia symptoms. What makes this protein disruptive in some cases but not others remains unclear.

This is one of the reasons why dementia research does not, and has never stopped at the amyloid hypothesis, influential as it may be.

The controversy has also meant that more and more researchers are looking into alternative or additional pathologies in Alzheimer’s disease and other forms of dementia, including the role of tau, another protein implicated in dementia, which, some experts say, may be a better indicator of Alzheimer’s disease progression.

In September, an animal study whose results appeared in PLOS Biology suggested that brain inflammation caused by a dysfunction in the blood-brain barrier may be a likely cause of Alzheimer’s disease.

“These findings may have a significant global impact on the millions of people living with Alzheimer’s disease,” Prof. Warren Harding, chair of Alzheimer’s WA, told MNT about the study.

And in November 2022, a study published in Nature argued that disruptive swelling along axons, which form the link between neurons, may be the true cause of Alzheimer’s symptoms.

One emerging treatment for dementia is stem cell therapy, thanks to the potential of stem cells — which are a kind of “blank slate” cells — to differentiate and “specialize” into cells with different functions, thus providing healthy cells to replace those that have experienced some degree of “damage.”

Stem cell research has made great strides this year, with scientists looking at the potential of stem cell treatment in many incurable or difficult-to-treat diseases.

In April 2022, for instance, a study whose findings appeared in npj Regenerative Medicine showed how implanting induced pluripotent stem cells in rats with Parkinson’s disease-like motor symptoms helped reverse those symptoms by replacing damaged neurons.

Speaking to MNT about the study results, Dr. Jeffrey Kordower, director of the ASU-Banner Neurodegenerative Disease Research Center at Arizona State University, said that they gave him “great confidence” about the treatment’s applicability in human patients in the future.

Another stem cell therapy highlight made the press in summer 2022, when the fourth, and oldest patient yet with HIV and leukemia achieved remission after receiving a stem cell transplant.

The patient, a 66-year-old man, achieved long-term remission of HIV 3 years after receiving a stem cell transplant for leukemia, which is a blood and bone marrow cancer.

“When I was diagnosed with HIV in 1988, like many others, I thought it was a death sentence. I never thought I would live to see the day that I no longer have HIV,” the patient declares in a statement for the press.

Creating embryo and brain models from stem cells

Stem cell research has also reached other intriguing and much-debated heights this year. In August 2022, two different research teams reported having successfully created embryo models in the laboratory, using not sperm and egg cells, but stem cells to do so.

The embryo models managed to develop rudimentary structures, including a beating heart, blood stem cell circulation, a head region with folds, and the beginnings of a gut tube.

They are also viable enough to allow researchers to delve deeper into the study of embryonic development. Models like these can also help researchers steer free of experiments with potential ethical implications.

Other researchers managed to create brain organoids — models of brain tissue — from stem cells in the lab. Such models can help scientists learn more about rare neurological conditions, such as microcephaly, where the size of the brain is reduced compared to that of a healthy brain.

More widely, researchers could use models of brain tissue to better understand the way in which viruses, such as SARS-CoV-2, might attack and affect the brain, and to further dementia research.

The importance of stem cell donation

Our own Managing Editor, James McIntosh, donated stem cells earlier this year to help further research on better treatments for people with blood cancers and blood disorders. James talks about his experience at length in a “Through My Eyes” personal perspective article.

When a person donates blood, they can also choose to donate stem cells, which are separated through a process called “apheresis.” It may seem like an unsettling experience, but, James wrote, it was nowhere near as scary as a first-time stem cell donor might think.

In his article, he explains how apheresis works:

“All the heavy lifting was going to be done by a cell-separating machine. The nurse inserted a needle into a vein in my left arm from which my blood was drawn into the machine. The machine then separated the blood into its separate components: red blood cells, white blood cells, plasma, and platelets. Once the blood was separated, the parts containing my precious stem cells were taken away, leaving the rest of the blood to return to me. The nurse inserted another needle into a vein in my right arm, and the blood was able to rejoin my bloodstream here from the machine.”

James encourages everyone who can to donate stem cells for treatment and research: “Stem cells are a vital part of treatment for several serious conditions while also showing a lot of potential in the development of new therapies for currently untreatable diseases. As a result, it is very important for there to be people willing to donate their stem cells. Many will be able to save lives by joining a donation register.”

Our January 2022 podcast on blood donations and transfusions further explains how blood donation works, how to prepare, what the different types of blood donation are, and why this is such a vital part of medical treatment and research.

Another research avenue that has been gaining ground in 2022 is the use of psychedelics in the treatment of anxiety and depression.

Around the world, hundreds of millions of people live with anxiety or depression, which can severely affect their quality of life.

The standard treatments for these mental health conditions include psychotherapy and cognitive behavioral therapy (CBT), as well as medications such as serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) — also known as “antidepressants” — which are meant to help rebalance the levels of key chemicals in the brain.

However, according to some estimates, up to 30{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of adults living with major depressive disorder have treatment-resistant depression, which does not respond to standard lines of treatment.

And around 50{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of adults with generalized anxiety disorder do not respond to first-line treatments, such as antidepressants.

In a bid to find more effective ways of addressing the symptoms of hard-to-treat depression and anxiety, researchers have turned to a sometimes-controversial line of inquiry, namely psychedelics, particularly ketamine, LSD, and psilocybin, the psychoactive compound in magic mushrooms.

What do psychedelics do?

These drugs are, for the most part, illegal in the U.S. and elsewhere, at least for personal use, but researchers can study their effects in humans under closely supervised, clinical trial conditions, and the results of some of these studies have been intriguing.

In our May 2022 podcast, we spoke to Dr. Adrian Jacques Ambrose, medical director of the Columbia Psychiatry Practice Office.

“For anxiety disorder, as well as panic disorder, there’s hyperactivation of what we call the fear network. [By this] I mean specific parts of the brain that includes the thalamus, the amygdala, the hippocampus, and the striatum,” Dr. Ambrose explained.

And since the human brain has a negativity bias — meaning it tends to hold onto negative memories and emotions — this may exacerbate the negative thinking that occurs in anxiety and depression.

Dr. Ambrose believes that standard treatments such as antidepressants may not always work “because of their lack of specificity.” In contrast, psychopharmacological treatments may be able to “rewire” the parts of the brain involved in this vicious cycle of negative thoughts.

Indeed, a study whose results appeared in JAMA Psychiatry in October 2022 concluded that ketamine can ease depression symptoms in as little as 4 hours by “updating” negative beliefs that people with severe depression hold about themselves and the future.

“We observed each patient before and after ketamine and found an early cognitive effect on beliefs about the future. Notably, patients started to show an optimism bias in belief updating 4 hours after [the] first, single infusion. At one week of treatment, the optimist bias in belief updating correlated to the clinical antidepressant effect,” says study author Dr. Liane Schmidt.

And in November, a study from NEJM found that a single, 25-milligram dose of a synthesized formulation of psilocybin also relieved the symptoms of treatment-resistant depression, although the exact way in which psilocybin acts on the brain remains unclear.

The catch

While studies such as the ones mentioned above seem to indicate that psychedelics may indeed be the way to go when it comes to severe anxiety and depression, they all come with a series of caveats.

In the JAMA Psychiatry study, the participants received ketamine infusions, which is a very specific method of administration. They also received their regular antidepressant treatment throughout the study period.

Speaking to MNT, Dr. Guochuan Emil Tsai, neuropsychiatry expert and CEO of the company SyneuRx, not involved in the study, pointed out that:

“Ketamine infusion is available but not commonly used. It’s usually reserved only for treatment-resistant depression and can only be done in facilities that offer IV infusion and can monitor patients. It would be similar to a dialysis center. Ketamine is also a Schedule III controlled substance with inherent risks.”

The NEJM study came with an even greater caveat: Although psylocibin did help reduce depression symptoms in most of the participants, about a week after the treatment, the most commonly reported side effects were suicidal ideation and intentional self-injury.

“It’s not a recreational process — it”s not like do-it-yourself self-help,” Dr. David A. Merrill, psychiatrist, and director of the Pacific Neuroscience Institute’s Pacific Brain Health Center at Providence Saint John’s Health Center in Santa Monica, CA, not involved in the study, told MNT in an interview.

“It really needs to be done with professionally trained, licensed, or certified practitioners who understand the power of these drugs to create a mind-altered state. Dissociation, even at times hallucinations, [are] part of the journey of psychedelics to open the mind to new possibilities, but that journey needs to be supported with professional help,” stressed Dr. Merrill.

So in the course of studying psychopharmacological treatments, a few questions remain: What are the safest doses and delivery methods? Do the benefits outweigh the risks? And who would most benefit from these interventions?

Our editorial team hopes that, in 2023, we may be one step closer to finding the answers to these and other questions that could transform healthcare practices for the better, and that our audience will continue to join us in our exploration of medical innovations.

2022’s most interesting health care research papers, according to the experts

Though the pandemic and all its attendant health care crises remained the major health care story of 2022, churning all the while in the background has been the critical work of academic scholars, operating on longer timelines, who are still trying to make sense of US health care and of medicine itself, to get a better idea of what’s wrong and how to make it better.

To wrap up this year, I asked a couple dozen health policy experts what research released this year (though, as one of them reminded me, these papers are often years in the making) had surprised them, changed their thinking, or struck them as especially notable.

Here are five particularly interesting papers, at least in my view. Because many more than that warrant mention, I have tried to cram in as many references to other work as I could. One of my lessons from this exercise was that there are noteworthy new studies being produced all the time. The US health system certainly merits such extensive investigation, given the number and diversity of its flaws.

These studies cover a broad range of subjects, from the intricacies of Medicaid provider networks to prescription uptake by Medicare beneficiaries to how bystanders react when a person experiences a cardiac episode in public. But first, on the topic of the pandemic…

1) Vaccination education campaigns in nursing homes didn’t make much difference

Several experts pointed me to data sets related to Covid-19 vaccination in nursing homes, the scenes of so much illness and death in that frightening first year of the pandemic. Larry Levitt, executive vice president of the Kaiser Family Foundation, flagged one recent KFF survey that found less than half of nursing-home residents are up to date on their vaccines.

That put into sharp relief the findings of a study that Harvard Medical School’s David Grabowski cited as one of his favorites of the year. The paper, published in JAMA Internal Medicine in January 2022, evaluated an effort to use educational campaigns and other incentives to improve vaccination rates among residents and staff in nursing homes.

They did not find a meaningful effect, despite three months of programming. There was plenty of room to grow, particularly among the staff, roughly half of whom were unvaccinated during the study period. (Vaccination rates among residents were already high at the time, though the experiment still did not find a significant effect of the multi-faceted campaign.)

“The conventional wisdom was that a big part of lagging vaccination rates was a lack of information and knowledge about the benefits of vaccination,” Grabowski said. But this study found instead that “these educational efforts were unsuccessful at encouraging greater vaccination. Although information campaigns sound like great policy, they really aren’t.”

He lamented that the study had been ignored by policymakers, noting federal efforts to increase vaccination rates among this population remain focused on education. Grabowski said the policies with the strongest evidence are vaccine clinics and vaccine mandates for staff.

2) Medicaid’s “phantom” networks may overstate patients’ access to health care

I love good jargon, and “ghost physicians” is one of my favorite new phrases of the year, which was recently brought to my attention by Harvard University professor (and former Vox contributor) Adrianna McIntyre.

It comes from this May 2022 Health Affairs paper, authored by Yale University’s Avital Ludomirsky and colleagues, which evaluated the provider networks of Medicaid managed-care plans. Those are privately administrated plans for low-income people that must follow state and federal Medicaid rules; they have grown in enrollment in recent years, with more states deciding to outsource their role in providing health coverage for the most vulnerable.

One of those rules is that enough doctors and hospitals accept those Medicaid plans, otherwise known as network adequacy. The Health Affairs study examined managed-care plans in four states over several years to get a better sense of providers’ participation in the program.

Their most striking finding is that while nominal participation was fairly high, about one-third of providers who technically accepted Medicaid actually saw less than 10 Medicaid beneficiaries in a given year. The responsibility for providing care to these patients was concentrated among a small number of practices, with 25 percent of primary care doctors providing 86 percent of the care and 25 percent of specialists providing 75 percent of those services.

In other words, while plenty of doctors might say they accept the plans, people who are enrolled in them may in practice find they have relatively few doctors to choose from. “Our findings suggest that current network adequacy standards might not reflect actual access,” the authors wrote in their conclusion. “New methods are needed that account for beneficiaries’ preferences and physicians’ willingness to serve Medicaid patients.”

The move toward more Medicaid-managed care has spurred a lot of debate and study. Matthew Fiedler, senior fellow at the Brooking Institution, sent me a Harvard study with its own surprising finding: In Texas, transitioning Medicaid enrollees to managed care had actually led to an increase in the use of prescription drugs and outpatient services, while the number of avoidable hospitalizations fell.

What seems to have happened, Fiedler said, is the state had been “penny-wise, pound-foolish” when running the program itself by imposing an unusually strict cap on the number of prescriptions patients could fill in a year. With that cap relaxed under the managed-care plans, patients filled more prescriptions and that corresponded to fewer episodes in which they ended up in the hospital when they didn’t have to.

Fiedler thought the study could also have implications for Medicare Advantage as well, another version of a government health insurance program that is being administered by private companies.

“To be clear, in many of these cases, it might well be better to fix this problem by just fixing the public program directly,” he told me. “But given that we often seem unwilling to do that, this does point to one very real advantage of involvement from private plans.”

3) Many Medicare beneficiaries don’t fill important prescriptions

Rachel Sachs, who studies prescription drug policy at Washington University in St. Louis, highlighted a study on a similar subject that was published in Health Affairs in April 2022, led by Vanderbilt University’s Stacie Dusetzina. The researchers studied the difference in prescription uptake by Medicare beneficiaries who receive a government subsidy to offset their drug costs versus those who do not.

The latter group, who can sometimes be on the hook for hundreds of dollars for every prescription they fill, was substantially less likely to actually use their medication as it had been prescribed, even for serious diagnoses like cancer. People receiving subsidies were twice as likely to fill their prescriptions. The study found that 30 percent of prescriptions for anti-cancer drugs and 22 of prescriptions for hepatitis-C treatment were never started.

The problem of drug affordability for Medicare patients has been an ongoing concern. Because of how the program is currently structured, beneficiaries who are enrolled in the traditional Medicare program but do not qualify for subsidies have no upper limit on how much they can be asked to spend on pharmaceuticals in a given year.

As part of the Inflation Reduction Act, Congress is instituting such a cap for the first time, using savings from the new drug pricing controls also included in the law, capping out-of-pocket costs at $2,000 starting in 2025. That is the kind of intervention the Health Affairs authors were calling for when they published the paper. Now we’ll see if that policy change has an effect on seniors actually taking their medicine.

4) Black and Hispanic Americans are less likely to receive CPR in public spaces

One of the experts I asked for input is Harvard Medical School’s Michael Barnett, who publishes his own overview of the year’s best research every year on Twitter. He sent me a few studies, most of which I’ll let him share in his own overview, but one study in particular stuck out, looking at which people are more (or less) likely to get assistance when they have a health emergency in a public setting with other people around.

The paper, published in the New England Journal of Medicine in October by a collection of scholars across the country, examined more than 100,000 incidents of cardiac arrest that occurred outside of the hospital from 2013 to 2019. They focused in particular on whether the person experiencing cardiac arrest in public received CPR from a bystander.

The results were profound: Black and Hispanic people were significantly less likely to be given CPR than a white person, 45 percent versus 60 percent. And this pattern held across neighborhoods of different racial and socioeconomic make-ups. Whether the neighborhood was predominantly white, Black, or Hispanic, up and down the income ladder, in integrated neighborhoods, white people were more likely to receive CPR than someone who is Black and Hispanic.

“Racial and ethnic differences in bystander CPR in public locations raise additional concerns about implicit and explicit biases in layperson response to out-of-hospital cardiac arrests,” the authors wrote.

Racism within the medical system is well established. Black and Hispanic Americans tend to have less access to health care. They tend to have worse experiences with doctors. Clinical trials and other research does not prioritize them. Medical treatments tend to be developed and designed with white people in mind.

But this study would suggest that even the more casual forms of racism and internalized bias can have a real health effect for marginalized Americans.

5) Prices go up after private equity acquires a physician’s practice

Private equity’s deeper investment into US health care is one of the most important ongoing stories in the field right now. The stakes can be life or death, as one paper that I covered last year about mortality rates in nursing homes purchased by private equity firms found. (Of note this year, according to Harvard’s Amitabh Chandra, was another paper that documented the wide disparities in outcomes among nursing homes, even those who are located in the same area.)

A report published by scholars from Johns Hopkins, Harvard, and Oregon Science & Health University in September 2022 in JAMA Health Forum, which Emma Sandoe of North Carolina Medicaid and Duke University shared with me, examined what happened to costs and care utilization when private equity firms had purchased outpatient practices specializing in ophthalmology, dermatology, and gastroenterology, some of their favorite targets.

The study detected several effects: The cost of individual services went up and those practices were seeing more new patients and also charging more time for their existing patients. The amount billed by the private equity-acquired offices per service increased by 20 percent compared to the study’s control group. They saw 38 percent more new patients and there was a 9 percent increase in the number of existing patient visits that were billed as lasting longer than 30 minutes.

On the surface, that could look like partially good news, in spite of the price hikes, with more patients being seen and spending more time with their doctor. But some of the other findings call into question the value of those increases in service volume. In dermatology, the increase in outpatient visits did not correspond to an increase in biopsies ordered. In the gastroenterology practices, there were more visits and scopes but no notable increase in polyp removals. And likewise, at the eye clinics, there was more diagnostic imaging but not any effect on actual cataract removals.

The authors ended their paper with this warning. “Private equity ownership of physician practices has added a distinctly private and market-driven influence to the broader trends in corporate consolidation of physicians by health systems and insurers,” they wrote. “This study contributes evidence for potential overutilization and higher spending on care that will be important for policy makers to monitor.”

Outlook on the Medical Devices Contract Research Organizations Global Market to 2035

Outlook on the Medical Devices Contract Research Organizations Global Market to 2035

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Dublin, Dec. 19, 2022 (GLOBE NEWSWIRE) — The “Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, and Key Geographies: Industry Trends and Global Forecasts, 2022-2035” report has been added to ResearchAndMarkets.com’s offering.

This report features an extensive study of the current market landscape and future opportunities associated with the medical device contract research organizations market. The study also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices.

Moreover, the medical devices are expected to capture more than 40{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years.

However, only a few players engaged in this domain claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in this domain.

In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments.

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in this domain.

Further, in order to support the growing demand, medical device CROs have been re-evaluating and bolstering their existing capabilities to offer a wide range of services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors.

To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent grow, till 2035.

The report features detailed transcripts of interviews held with the following stakeholders:

  • Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)

  • Lee King (Senior Vice President, Business Development and Marketing)

  • Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)

  • Claus Hemiker (Head, Business Development)

  • Christian Wolflehner (General Manager, CW Research & Management)

  • Troy W. Mccall (Chief Commercial Officer, CROMSOURCE)

  • Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research)

  • C. Omprakash (Technical Director and Partner, Vyomus Consulting)

  • Tania Persson (Director of Business Development, A+ Science)

  • Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

  • Who are the key players engaged in offering contract research services for medical devices?

  • Which regions represent the key contract research hubs for medical devices?

  • What are the key regulatory guidelines, related to medical devices that have been established across various geographies?

  • What are the key value drivers of the merger and acquisition activity observed within this domain?

  • What percentage of the medical devices research operations are presently outsourced?

  • What are the likely future trends in contract research services market for medical devices?

  • How is the current and future opportunity likely to be distributed across key market segments?

  • What is the total cost of ownership required to set up a medical device contract research organization?

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Medical Devices
3.2.1. Historical Evolution of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations While Selecting a Suitable CRO Partner

4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Area of Specialization
4.2.6. Analysis by Device Class
4.2.7. Analysis by Type of Clinical Operation Service Offered
4.2.8. Analysis by Type of Regulatory Affairs-related Service Offered
4.2.9. Analysis by Type of Additional Service Offered
4.2.10. Analysis by Medical Device Regulatory Compliance Authority
4.3. Medical Device CROs: Preclinical Service Providers
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Analysis by Type of Preclinical Service Offered
4.4. Medical Device CROs: Standalone Service Providers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Analysis by Company Size and Location of Headquarters

5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.4. Regulatory and Reimbursement Landscape in Europe
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks

6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Recent Developments and Future Outlook
6.3. Charles River Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Recent Developments and Future Outlook
6.4. CROMSOURCE
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Recent Developments and Future Outlook
6.5. CSSi LifeSciences
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Recent Developments and Future Outlook
6.6. Eurofins Medical Device Testing
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Recent Developments and Future Outlook
6.7. IQVIA
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Recent Developments and Future Outlook
6.8. Medpace
6.8.1. Company Overview
6.8.2. Service Portfolio
6.8.3. Recent Developments and Future Outlook
6.9. NAMSA
6.9.1. Company Overview
6.9.2. Service Portfolio
6.9.3. Recent Developments and Future Outlook
6.10. Qserve Group
6.10.1. Company Overview
6.10.2. Service Portfolio
6.10.3. Recent Developments and Future Outlook
6.11. WuXi AppTec
6.11.1. Company Overview
6.11.2. Service Portfolio
6.11.3. Recent Developments and Future Outlook

7. MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS
7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks

8. COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Assumptions and Methodology
8.3. Competitive Benchmarking by Region
8.4. Concluding Remarks

9. BRAND POSITIONING OF KEY INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: Labcorp
9.4. Brand Positioning Matrix: IQVIA
9.5. Brand Positioning Matrix: Syneos Health
9.6. Brand Positioning Matrix: PPD
9.7. Brand Positioning Matrix: ICON
9.8. Brand Positioning Matrix: Charles River Laboratories
9.9. Brand Positioning Matrix: WuXi AppTec
9.10. Brand Positioning Matrix: Medpace

10. CLINICAL TRIAL ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
10.4. Medical Devices: Analysis by Enrolled Patient Population

11. MERGERS AND ACQUISITIONS
11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Medical Device CROs: Mergers and Acquisitions

12. TOTAL COST OF OWNERSHIP IN MEDICAL DEVICES CONTRACT RESEARCH ORGANIZATION
12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Expenditures Incurred by a Medical Device Contract Research Organization
12.4. Total Cost of Ownership of Medical Devices Contract Research Organizations, 2022-2042
12.5. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by CAPEX and OPEX Costs, 2022 and 2042
12.6. Concluding Remarks

13. SURVEY INSIGHTS
13.1. Chapter Overview
13.2. Designation of Respondents
13.3. Types of Services Offered
13.4. Target Therapeutic Area
13.5. Average Number of Annual Projects
13.6. Market Opportunity

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

15. SWOT ANALYSIS

16. FUTURE TRENDS AND OPPORTUNITIES

17. INTERVIEW TRANSCRIPTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/p3pds0

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

New Law Weeds Out Some Blockers to Medical Cannabis Research

Key Takeaways

  • A new law is making it easier for researchers to study cannabis.
  • Researchers previously faced barriers like lengthy study approval procedures and inadequate supply of high-potency products.
  • Experts hope new research on the medical use of cannabis might convince authorities to remove the drug from Schedule I designation.

A new Medical Marijuana Research Law is making it easier for researchers to study cannabis. The law is expected to expedite study approvals for scientists and allow for higher-potency cannabis in clinical trials.

Cannabis is still classified as a Schedule I drug, which is defined as having “no currently accepted medical use and a high potential for abuse.” Other drugs or substances in this category include heroin, LSD, and ecstasy.

So far, 37 states have legalized cannabis for medical purposes, but the Schedule I classification imposes strict limits on cannabis research. Prior to the new law, scientists could not study the effects of high-potency products, and the process of obtaining study permits could take months.

The Drug Enforcement Administration (DEA), which is responsible for reviewing cannabis research applications, was free to take as long it wanted to issue a decision, according to David A. Gorelick, MD, PhD, DLFAPA, a distinguished life fellow of the American Psychiatric Association.

The new law removes some of these restrictions, stipulating that the U.S. attorney general must approve or deny a researcher’s application within 60 days.

“Right now, research is considered somewhat cumbersome,” Gorelick told Verywell. “The [law] has the most promise in the future to kind of unblock the cannabis medical drug-related development process.”

What Else Could This Law Change for Cannabis Research?

Among other changes, the law relaxes the rules on cannabis growers who supply the drug for scientific research.

In the past, the maximum grade for research-use Delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, was lower than what people used legally and illegally, Gorelick explained.

“The complaint from researchers was that the cannabis they had to use for their own research was not representative of what people were actually using,” he said.

Gorelick said he expects higher-quality cannabis to be used in more rigorous clinical research studies in the near future. If researchers can prove that cannabis has legitimate medical use, they might be able to convince authorities to remove cannabis from its Schedule I designation.

The difficult task is that researchers need to get more granular in their studies and test if cannabis can be used to treat a specific condition or disease, according to Larry Walker, PhD, MS, a pharmaceutical researcher at the University of Mississippi.

Currently, in states where medical cannabis is legal, a healthcare provider could issue a permit for patients with conditions such as severe chronic pain, cancer, HIV/AIDS, epilepsy, and multiple sclerosis.

“The capsule form that’s available for prescription is Schedule III,” Walker said.

If the Food and Drug Administration (FDA) agrees that cannabis has legitimate medical use, he added, the drug could be given a Schedule II or an even lower designation.

For now, the law symbolizes the biggest breakthrough in research access.

“This is giving a nudge that [study reviewers] have to respond more quickly and they have to acknowledge that there may be legitimate drug development purposes that shouldn’t be thwarted.” Walker said.

What This Means For You

A new law is making it easier for scientists to research cannabis for medical use in the United States. But the drug is still on a Schedule I designation along with other substances like LSD, ecstasy, and heroin.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Drug Enforcement Agency. Drug scheduling.

  2. National Library of Medicine: MedlinePlus. Medical marijuana.

New Law Weeds Out Some Blockers to Medical Cannabis Research

By Claire Wolters

Claire Wolters is a staff reporter covering health news for Verywell. She is most passionate about stories that cover real issues and spark change.

America’s Primate Shortage Hinders Medical Research

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The US economy faces yet another painful supply shortage – not microchips but monkeys.

Scientists, who fear they’re falling behind on crucial medical progress, have urged the US government to increase spending on lab monkey breeding programs as a smuggling scandal in Cambodia risks worsening an existing scarcity of little monkeys native to Southeast Asia.

Everybody’s Got Something to Hide…

Last month, US federal prosecutors indicted eight people for their roles in an alleged monkey smuggling ring that supplied simians to research labs in Florida and Texas [we’ll wait for you to read that back]. The macaques, which are used to develop vaccines and advance medical research, were allegedly abducted from national parks and other protected areas in Cambodia and taken to breeding facilities where they were provided false export permits. One of the people arrested was actually a wildlife director on his way to a conference on protecting endangered species.

As far as American medical research is concerned, there just aren’t enough monkeys to go around. During the height of COVID, China, which was the US’ biggest supplier at the time – levied an export ban on lab monkeys, causing the price of one primate to triple between 2019 and 2022. A monkey that once went for roughly $5,000 now goes for about $22,000 and the price is expected to increase another 10 grand next year. A barrel of monkeys sure isn’t cheap.

With China now entering yet another wave of Covid outbreaks, fears of a new variant will return, pushing US medical researchers to develop new vaccines without a ready supply of testing subjects:

  • Nancy Haigwood, director of the Oregon Primate Research Center, told the Financial Times her group is a year behind on testing and has grant funding sitting on the shelf because she can’t procure enough primates.
  • Suppliers Charles River and Inotiv recently warned investors to expect disruption in monkey imports from Cambodia. The US National Primate Research Centers have seven breeding facilities with roughly 25,000 primates, but that’s not nearly enough to meet demand.

“Most years, I can say with confidence that the NPRC barely meets, or are unable to meet in a timely manner, all requests,” Wisconsin primate center director Jon Levine told Mother Jones. “We have been chronically receiving no increases in our budgets, or very modest increases in our budgets, for over 20 years.”

Friends, Not Equipment: Of course, one group is happy to see scientists struggling to get more monkeys. Animal rights organization Peta, which has boycotted animal testing for decades, says the US stinks at breeding monkeys so it’s had to rely on stolen primates. Lisa Jones-Engel, Peta’s senior advisor, said the US should switch to more human testing instead. “We have to stop the monkey experimenters from hijacking the funds needed to implement them.”