ACNP testing - AG - Acute Care Nurse Practitioner Updated: 2023

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Following certain lifestyle choices can help in reducing diabetes risk.

Diabetes has always been the course of concern, especially among young professionals According to the World Health Organization, 77 million people above the age of 18 are suffering from Type 2 Diabetes and nearly 25 million people are at risk of diabetes. While lifestyle factors like diet, physical activity, and stress play a significant role in the development of diabetes, genetic predisposition is an equally important contributing factor. Additionally, according to the National Library of Medicine, If a young adult has one parent lineage who is diabetic, the chances of them being diabetic are 40% and if both parents lineage have a history of diabetes, the chances of developing it increases to 70 percent. Dr Anu Prabha, Research Scientist and Product Manager, Human Genomics, Haystack Analytics shared some thoughts related to the increasing diabetes cases in young professionals and how genetic testing can be a better option to choose.

To manage this, apart from adopting healthy dietary choices and inculcating physical activities into their daily routine, individuals should opt for genetic testing that can enable medical practitioners to design personalized care for their patients in terms of medications, nutrition, fitness, and overall lifestyle.

Here Are Some Benefits Of Opting For Genetic Testing!

Early Intervention

One of the topmost benefits of genetic testing is early intervention which helps the doctors understand the genetic makeup of an individual's body and the diseases they are susceptible to, which allows the doctors to detect the disease at an earlier and more treatable stage.

Reducing The Risk Of Long-Term Lifestyle Diseases

Another benefit of understanding the blueprint of your DNA is reducing the risk of long-term diseases. Once the doctors understand your susceptibility to certain diseases, instead of following the traditional method of care regime, they can tailor and customize your treatment accordingly to reduce the risk.

Customize Lifestyle Practices

As lifestyle habits play a crucial role in triggering a disease like diabetes, genetic testing will allow doctors, trainers, or dieticians to help optimize your lifestyle practices according to your DNA. This will not only enhance your overall well-being more effectively and efficiently but also help you to take tailored preventive measures to delay the risk of certain health problems.

In conclusion, individuals, especially young professionals should adopt a combination of healthy lifestyle choices and genetic testing to help them manage their overall wellbeing more effectively and delay the onset of diseases like diabetes. Following a holistic approach can always help keep your body and mind healthy, eventually taking you away from all chronic diseases. Just a few changes can show multiple effects.

On a Saturday in May in Flint, Mich., residents took seats in one of three rings of chairs at a local food bank. The 50 or so participants, spanning three generations, would spend time that morning sharing stories and practicing deep listening as part of a healing circle. It’s one component of a wider community-based movement to build relationships and challenge racist beliefs and systems.

In one circle, healing practitioner Todd Womack asked participants to introduce themselves and describe their favorite desserts. Fingers snapped softly to signal mutual enjoyment. Next, participants paired off, with instructions to take turns asking about something that recently made them smile or laugh — and to listen without interruption. From there, new pairs moved to other topics, such as an accomplishment they were proud of.

Healing circles are a space to foster community, says Lynn Williams, the director of equity and community engagement at the Community Foundation of Greater Flint, who helped organize the event that morning. The circles allow room for “healing of trauma from systems, from oppression, from negativity,” she says. And they provide a place to tell a community’s full story, to “highlight the assets and the cultural contributions.”

The circles are one way to let people know they matter when society keeps telling them they don’t.

The residents of Flint — a city with a majority Black population and many people experiencing poverty — know this disregard well. In April 2014, to cut costs, state officials switched the city’s water source from Lake Huron to the Flint River without an adequate treatment plan. The public health catastrophe that has followed “is a story of government failure, intransigence, unpreparedness, delay, inaction and environmental injustice,” according to the final report from the Flint Water Advisory Task Force, commissioned to find the causes of the water disaster. The human-made crisis turned a necessity into a hazard for the residents of the city, which had a population of around 99,000 at the time. The lack of proper treatment exposed people to bacteria, excessive disinfection chemicals and lead.

Residents reported that their physical health suffered. People broke out in rashes, lost hair and had gastrointestinal illnesses. Researchers found an association between a local, deadly Legionnaires’ disease outbreak in 2014–15 and insufficient disinfection in the water system. Many children have developed health and behavioral problems from lead poisoning. “I am so upset,” says Bishop Bernadel Jefferson of Faith Deliverance Center in Flint, speaking of her grandson’s lead exposure and subsequent learning difficulties. “The system failed him.”

Mental health has suffered, too. Residents have reported experiencing depression, anxiety and post-traumatic stress disorder. With disasters, especially those that involve toxic exposures, “the emotional consequences are long-term, because they’re fueled by this concern [that] health or cognitive functioning has been forever adversely affected,” says Evelyn Bromet, a psychiatric epidemiologist at the Renaissance School of Medicine at Stony Brook University in New York who has studied the Chernobyl nuclear power plant disaster.

For a year and a half, officials dismissed residents’ concerns about the safety of the water. “It was horrifying, because not only were they not believed, but they weren’t taken seriously,” Bromet says. The anger that goes along with that “is of course a detrimental emotional state to be in for a long period of time.”

Other difficult experiences compounded the anguish that came with the water disaster. “This community has been exposed to multiple traumas,” says Womack, a social worker at the University of Michigan–Flint. When the disaster began, Flint was still struggling with the loss of tens of thousands of jobs due to General Motors’ layoffs and plant closures from the 1970s to the 1990s. The COVID-19 pandemic began as the water disaster continued.

Mental health remains a pressing concern for the community. But there aren’t enough mental health providers to meet the need, says Barbara Wolf, a clinical health psychologist at McLaren Health Care in Flint. Genesee County, which includes Flint, is among the areas in the United States with a shortage of mental health professionals, according to the U.S. Department of Health and Human Services.

So, as they’ve done before, Flint residents are finding a way. It was the community’s organizing and activism that brought attention to the water disaster. And as Flint approaches 10 years since the disaster began, local organizations continue to help the community heal. There are mental health and resiliency trainings, mindfulness meditation and community conversations about mental health. “There’s not just one approach,” says Kristin Stevenson, project manager for the Flint Resiliency in Communities After Stress and Trauma, or ReCAST, program at the Greater Flint Health Coalition, and a healing practitioner. “All of these things combined are what create the impact.”

What has happened in Flint — and what continues there — illustrates a community’s activism and perseverance, as well as the mental health fallout of a disaster. But this story won’t end in Flint. Communities across the country could find themselves part of the next chapter, their lives upended by catastrophe. The United States’ aging water infrastructure has led to other water crises and could trigger more. Wildfires, hurricanes and floods, fueled by climate change and other human-caused environmental changes, are increasing in frequency and destructiveness. Mental health will suffer in the aftermath of these traumatic events. The water disaster in Flint can be seen as both a warning and a model of community response.

“We recognize that our struggle, if not now, will become yours,” Womack says.

The making of the water disaster in Flint

A decorative archway spanning one of downtown Flint’s main thoroughfares reads “Flint: Vehicle City.” The city was home to a booming carriage business before General Motors was founded there in 1908. Residents look back with pride on the community’s activism during GM workers’ famous sit-down strike for better pay and recognition of their union, the United Auto Workers. For around six weeks in 1936–37, striking workers occupied factories to stop production. Family and community members provided supplies and support from the outside. The strike heralded the rise of the labor movement in the automotive industry.

As in other cities, Flint’s industrial growth was detrimental to its river, as factories would discharge waste directly into the water. The Clean Water Act of 1972, which regulates pollution from industrial and municipal sources, has improved the health of U.S. waterways, including Flint’s. In 1974, the Safe Drinking Water Act was enacted to safeguard the country’s drinking water. The law sets standards for levels of contaminants, including microorganisms, chemicals and metals such as lead.

In 2014, Flint’s water treatment plant hadn’t been fully operational for almost 50 years. Instead, the city had been purchasing treated Lake Huron water from Detroit’s water utility. But an unelected emergency manager, placed in charge of Flint’s finances by Michigan’s then-Governor Rick Snyder, had authorized a switch to the Flint River as a cost-saving measure. Water treatment is a complex process, and the Flint River water was more corrosive than other water sources. But the Flint plant didn’t test its treatment procedures sufficiently, according to an analysis by water treatment experts. In violation of federal requirements, there was no corrosion control treatment, which helps prevent lead from leaching into the water as it moves through the distribution system’s pipes.

When residents turned on their faucets in the weeks after the switch on April 25, they were unsettled by what came out. “I used to love tap water, just to run it and let it get cold,” Jefferson says. But after the switch, the water left a film in her mouth. Flint resident Gina Luster liked to chew ice, but it started to taste “like metal, like I’m chewing steel.” Cynthia Watkins, apostle at the Well International Church Ministries in Flint, remembers the water “just smelling, it was horrible.” For Roshanda Womack, a professional storyteller and spouse of Todd Womack, the water had a strong odor and was sometimes cloudy or had a slight brown tinge to it.

People in the community spoke out about the poor water quality, with some reporting rashes from exposure to the water. But officials maintained that the water was safe for use.

Warning signs mounted in the following months. The water in the distribution system tested positive in August for E. coli, which can indicate fecal contamination and inadequate disinfection. This prompted a boil water advisory. In October, General Motors announced that it would stop using the city’s water at an engine plant over concerns about corrosion. While the company switched to a different water supply for manufacturing, officials still claimed Flint’s water met safety standards for people. Throughout 2014, church leaders and other community members worked to elevate people’s concerns about the water.

At the end of 2014, the city was served with a Safe Drinking Water Act violation, having exceeded allowable levels of trihalomethanes, disinfection by-products tied to an increased risk of cancer. These chemicals form when disinfectant added during treatment reacts with naturally occurring materials in river and lake water. One of the challenges of water treatment is maintaining proper disinfection while limiting by-product chemicals.

After the public notice of the violation in January 2015, Flint resident LeeAnne Walters asked the city to test her water. Samples from February and March revealed lead levels around seven and 27 times what spurs regulatory action. Walters’ home plumbing was plastic. An analysis of the city service line to the house revealed it was the source of the lead. When Walters’ 4-year-old son was tested for lead in March, his level was 6.5 micrograms per deciliter. No amount of lead is considered safe. At the time, the U.S. Centers for Disease Control and Prevention used a reference value of 5 µg/dL, developed based on national surveys, to identify kids with the highest lead levels. In 2021, the CDC lowered that reference value to 3.5 µg/dL.

As the year continued, local organizations and churches formed the Coalition for Clean Water, which passed out flyers to inform residents of the water safety issues and collected water samples for testing. People protested, with rallies in Flint, Detroit and Lansing, the state capital. In August, organizers delivered to the mayor a petition, with more than 26,000 signatures, demanding to switch back to water from the Detroit system.

Then, at a September news conference, local researchers announced an alarming rise in the percentage of Flint children with lead levels of 5 µg/dL or higher. The analysis included children younger than age 5 who had had their levels checked as part of routine lead screening — 736 children in 2013, before the water source changed, and 737 after, in 2015. The percentage of kids considered to have high lead levels increased from 2.4 percent in 2013 to 4.9 percent in 2015, the researchers reported in 2016 in the American Journal of Public Health. In neighborhoods with the most lead in the water, the jump was from 4.0 to 10.6 percent. A similar change was not seen in 2,202 children who lived outside of the city and had a different water source.

Lead harms children’s developing brains and nervous systems. Studies have found that the metal disrupts communication between nerve cells and impairs the hippocampus, a brain region important in learning and memory. Children exposed to lead can develop learning disabilities, speech and hearing disorders, and behavioral problems. The damage can shape the rest of their lives.

Officials ultimately couldn’t brush aside the evidence of poisoned children. The city reconnected to the Detroit water system on October 16, 2015. But that water still had to flow through Flint’s pipes, which had become corroded. The city has been replacing its lead service lines but has repeatedly missed court-ordered deadlines and still isn’t finished. Lead levels have been in compliance with federal regulations since 2016 but have fluctuated recently. In 2022, lead levels rose to the highest seen in six years.

“We’re still not fixed,” says Kent Key, a health disparities researcher at the Flint campus of Michigan State University’s College of Human Medicine.

The Flint Water Advisory Task Force reported that the state government was primarily responsible for the water disaster.

The anguish Flint residents have felt

The Flint community organized, rallied and distributed testing kits and bottled water while people there lived through a disaster. “The water disaster was a traumatic experience,” Todd Womack says. “At the time, I don’t think people were saying it was traumatic. I think they were saying, ‘How do we get this basic need?’”

Eventually, the trauma rose to the surface. There had been so much worry, stress, anger and grief. Parents who had cajoled their kids to choose water over soda and juice were distraught. “I feel so guilty now,” Luster says. “I was poisoning my kid.” Pets died unexpectedly, which seemed to be tied to drinking the water. “I ended up losing both my dogs,” Watkins says. “That was just devastating.” Getting enough bottled water was a financial hardship for many. “I watched people, low-income families or on a fixed income … take half of their money to buy water every month,” Jefferson says.

And for so long, residents were told, “ ‘You’re paranoid, you’re crazy, the water is fine,’ ” Roshanda Womack says, “when you can see it’s not fine.” Jennifer Carrera, an environmental sociologist at Michigan State University in East Lansing, says there were “so many ways in which the treatment of the residents minimized their experiences…. Gaslighting is a very fair way of characterizing what happened to Flint residents.”

Yet General Motors got a different water supply for its plant. “For parts, for automobile parts,” Jefferson says, but not for people. “It was all right for us to be poisoned. It was all right to be sick. It was all right to die.”

Dionna Brown, a sociology graduate student at Wayne State University in Detroit, grew up in Flint and was a teenager during the water disaster. Brown felt “like the government is trying to poison a Black city.” She realized, “Black children, we can’t have a childhood. We have to grow up fast.”

“To live with that level of betrayal,” says Bromet, the Stony Brook psychiatric epidemiologist, “of course it takes its toll.”

As does the lack of justice. “The perpetrator, in a just and fair society, is held accountable,” Key says. “In the Flint water crisis, that still hasn’t happened.” The city has been “forced to work with the perpetrator, the state, to work towards recovery.”

The experience has left many unconvinced that the city’s water is safe. “I think you’re just going to have a large portion of the population that is never going to drink the water again,” says social epidemiologist Jerel Ezell of the University of California, Berkeley, who grew up in the Flint suburbs.

Worrying about water “puts a strain on you,” says Flint resident Tyshae Brady. “I don’t want to always go over to a friend’s house and go, ‘Hey, is your water safe to drink?’ ” The unease extends beyond Flint, too. Flint church elder Sarah Bailey, who has worked on stroke prevention in the community and other projects, recalls being at a Boston restaurant with colleagues. “The waitress brings some water to the table in glasses, and I reach over and say, ‘Do you happen to have any bottled water?’ ” One of her colleagues told Bailey the water was safe. “I said, ‘For you…. The water was not safe for me.’ ”

The mental health aftermath of the water crisis

The disaster has weighed heavily on the mental health of residents, both children and adults. From December 2018 to March 2020, researchers surveyed the caregivers of 1,203 children, ages 3 to 17. The caregiver-reported rates of anxiety and depression among the children were 13 percent for anxiety and 8 percent for depression, higher than the national rates of 9 and 4 percent for that age group, the researchers reported in September in the American Journal of Public Health.

A different research team surveyed 1,970 adult residents from August 2019 to April 2020 — around that time, Flint’s total population was just over 81,000. Twenty-two percent of the respondents had experienced symptoms of depression in the past year, while 24 percent met criteria for post-traumatic stress disorder. That’s higher than the estimated past-year rates, 8 percent for depression and 5 percent for PTSD, for the U.S. population. Extending the findings to Flint’s population suggests that around 13,600 adults may have experienced depression and around 15,000 may have had PTSD, the researchers reported in 2022 in JAMA Network Open.

People who were worried the water had harmed their or their family’s health were more than twice as likely to meet the criteria for depression and about 1.7 times as likely for PTSD, compared with people without this concern.

Past tragedies, such as a serious accident, physical abuse, sexual assault or a previous environmental calamity, can increase mental health risks when disaster strikes. “Your cumulative exposure to potentially traumatic events drives a lot of the risk for either developing or maintaining PTSD or depression,” says Dean Kilpatrick, a clinical psychologist at the Medical University of South Carolina in Charleston and one of the authors of the study in adults. Kilpatrick and colleagues found that the risk of developing symptoms of depression increased by a factor of close to three, and for PTSD symptoms by a factor of 4.6, for Flint residents with past exposure to a potentially traumatic event, compared with those without.

For some, mental health issues from disasters may persist for years. Researchers followed mothers who experienced Hurricane Katrina and had incomes less than twice the federal poverty line. The women were surveyed at three points after August of 2005, when the storm hit the U.S. Gulf Coast. Although rates of post-traumatic stress symptoms declined over time among the women, 1 in 6 still had symptoms 12 years after the hurricane, researchers reported in 2019 in Social Science & Medicine. Mothers with young children who were evacuees after the Chernobyl disaster and Chernobyl cleanup workers have had long-lasting mental health consequences.

Despite the potential impacts, only 35 percent of respondents in the study in JAMA Network Open reported that they had ever been offered mental health care to attend to issues that arose from the water disaster. If offered, most people — 79 percent — took advantage.

The COVID-19 pandemic, another traumatic experience, hit the community while they were still dealing with the water disaster. In the most recent Community Health Needs Assessment for Flint and surrounding Genesee County, from 2022, 45 percent of respondents to the assessment’s resident survey indicated that they were dealing with stress, and 33 percent said they had mental health problems such as depression or anxiety.

How the community is helping and healing

Having too few mental health care practitioners is not an issue unique to Flint. Nearly 166 million people in the United States, about half the population, live in areas with a shortage of mental health professionals. The COVID-19 pandemic has only exacerbated the problem.

Treatment options did recently expand somewhat in Flint. In May, local mental health services provider Genesee Health System opened a new outpatient clinic that serves uninsured county residents. The treatment facility is funded in part by a recently passed property tax increase to support mental health in the county.

Beyond that, Flint organizations are taking community-based approaches to help residents cope. The Flint ReCAST program, supported with a grant from the federal Substance Abuse and Mental Health Services Administration, funds local organizations seeking to address trauma and stress in the community. ReCAST has supported art, music and dance programs for young people and an initiative to build mindfulness skills among the police and community members.

ReCAST also funds Genesee Health System to offer free community mental health and resiliency trainings, on courses ranging from recognizing suicidal ideation to learning about mental health and stigma to building resiliency. ReCAST and Genesee mental health professionals have teamed up for virtual conversations about mental health called Talk About It Tuesdays.

The Flint Public Health Youth Academy, which Key began developing in 2014, is a homegrown initiative to inspire Flint’s young people to pursue careers in public health. “I wanted to create a youth group that did not allow the water crisis to be a sentence of doom and gloom,” he says, but rather a jumping-off point to create the next generation of public health professionals. Among the academy’s activities is an annual summer camp that centers on a public health topic, such as environmental justice.

Looking to the future, Stevenson, the project manager for ReCAST, is interested in bringing training of mental health ambassadors to Flint. The idea is to train trusted community members to be a source of mental health information for their neighborhoods. Stevenson is also a big proponent of healing circles as a way to help people heal and build resilience.

At the close of one healing circle on that Saturday in May, Todd Womack took out a skein of moss green yarn. Womack asked the participants to be ready to share something they appreciate about themselves. Womack went first, then tossed the skein to another participant while holding on to a piece of the yarn. As each person took a turn, the skein zigzagged across the space, unwinding along the way. In the end, everyone in the circle was holding on to the web of yarn, a physical reminder of the community and connections created that morning.

That afternoon, three different groups formed to discuss changes residents would like to see in Flint. People responded on sticky notes to different questions, such as what Flint would look like without gun violence. People talked about the city’s history, GM’s layoffs and the abandoned homes that still dot many neighborhoods, the result of years of population loss. After a peak of nearly 197,000 in 1960, the latest population estimate, from 2022, is under 80,000.

The people gathered that Saturday are among those who have stayed. They are Flintstones, as residents call themselves. While brainstorming about Flint’s future, playful chants broke out between the groups, each of which had taken on a Flint-related name. “Flintstones!” one group cried. “810!” another responded, referring to the local area code. “Bedrock!” boomed the third, naming the town from the old The Flintstones cartoon.

When residents reflect on Flint, the strong sense of community comes up again and again. It’s how residents have stood up for their health and safety during a disaster, and it’s how they continue to care for each other.

“There’s really this unity and connectedness with anyone who has lived here,” Todd Womack says.

“We’re a loving city,” Dionna Brown says, “and we’re going to be OK.”

“There are amazing, deeply committed people that live here … there’s a lot of commitment, there’s a lot of passion,” Lynn Williams says. “And that’s why we stay.”

Research that could lead to the first early detection blood test for pancreatic cancer has received critical funding from PanKind, The Australian Pancreatic Cancer Foundation.

Pancreatic cancer is one of Australia's biggest killers, with poor survival rates marred by a lack of distinct symptoms and screening tools needed to detect the disease in its initial stages.

It's hoped the test will, for the first time, accurately identify patients with early stages of pancreatic cancer – a crucial step towards improving survival rates and quality of life for patients.

At a glance

• Project to develop a blood-based test to identify patients with early pancreatic cancer receives PanKind funding boost.

• The test is based on a critical WEHI discovery of proteins that can identify early pancreatic cancer in patients. Currently, there are no early detection biomarkers for the disease.

• Researchers hope the test could, in future, be used by general practitioners and oncologists as a tool for early intervention to enable more effective treatment options for patients.

Pancreatic cancer is projected to be the fourth biggest cancer killer in Australia this year, with 3600 people predicted to die from the disease.

It is often diagnosed late due to a lack of specific symptoms in the early stages of the disease, meaning most patients are diagnosed once the cancer has grown and has already begun to affect nearby organs.

Project lead Dr Belinda Lee said the new grant would help the team translate their findings into a diagnostic test, potentially improving the lives of hundreds of thousands of people in Australia and around the world.

"There are no early detection biomarkers for pancreatic cancer and this needs to urgently change," Dr Lee, a consultant medical oncologist at WEHI, said.

"We have identified 13 proteins that could distinguish between the early and late stages of pancreatic ductal adenocarcinoma (PDAC) – the most common type of pancreatic cancer that's fast-becoming the cancer of our generation.

"While the 5-year survival rate of most other cancers has improved, the incidence and death rate from PDAC is rising – and it's projected to become the second leading cause of cancer-related death by 2030.

"Even with a diagnosis, there are no biomarkers that can guide clinical decisions for pancreatic cancer, meaning clinicians have limited opportunities to ensure the right, and best, treatment for their patients.

"We hope to validate these proteins and show that they can be used to reliably screen for early pancreatic cancer.

"This would allow us to create the first diagnostic test to identify patients who have early stages of pancreatic cancer – something that unfortunately does not exist at the moment."

Significant data

To achieve this goal, researchers will leverage the global PURPLE Pancreatic Cancer Translational Registry, established by Dr Lee at WEHI in 2016 with philanthropic support, which also helped the team identify the 13 critical proteins.

The registry is a large-scale database that tracks the treatment journey of patients at 48 cancer centres across Australia, New Zealand and Singapore, with over 4000 patients and 2000 biospecimens currently available.

Data from the registry confirms that 70% of patients present with advanced disease, highlighting the need for biomarkers to enable earlier detection.

"We will utilise state-of-the art technologies and computational methodologies to compare the protein signature in the blood of healthy individuals, to pancreatic cancer patients with early and late-stage disease," Dr Lee said.

"The results will allow us to identify potential novel blood-based biomarkers that can be further developed to create a simple, non-invasive screening test to identify early-stage pancreatic cancer.

"We hope this test can be used by general practitioners to identify patients with disease, or by oncologists to identify the right treatment for patients.

"The ultimate goal is that this tool leads to earlier diagnosis of this silent cancer, thereby increasing the number of patients who go into remission and helping us triple survival rates by 2030."

The project, Development of a blood-based test to identify patients with early pancreatic cancer, is supported by PanKind's $100,000 Marianne Allan Pancreatic Cancer Research Grant.

TAMPA (BLOOM) – The DUTCH Plus is said to be a comprehensive dried urine and saliva test that maximizes the available information from sex and adrenal hormone production and metabolism.

Nurse practitioner, board certified health coach & certified creation coach, Lori Finlay, joined Gayle Guyardo the host of the global health and wellness show Bloom, to share why it’s important to have this added layer of protection.

WASHINGTON (SOA) — There’s a growing national conversation about toxic chemicals known as PFAS, as federal health bodies take action to address contamination and assess health risks. We first reported on a new study linking a PFAS chemical to testicular cancer earlier this week. Now, in an exclusive report, we examined new data about PFAS found in servicemembers’ blood and new efforts in Washington to get care and compensation for those exposed.

Retired Air Force firefighter Kevin Ferrara remembers working with AFFF, firefighting foam we now know was made with PFAS, toxic forever chemicals that have been tied to a host of health problems including cancer.

"They told us it's soap and water and we believed it," Kevin Ferrara told Spotlight on America. "We slathered ourselves in this stuff, it came into contact with bare skin and eyes, nose and mouth."

Today, Ferrara has made it his mission to help firefighters understand the potential risks from their exposure to that foam. He told us firefighters come to him and ask about the health risks. "Usually the first question I get is, 'Am I going to get cancer?'" said Ferrara.

Answering those questions is complicated, but new studies are shedding light.

As we first reported earlier this month, a first-of-its-kind federal study performed the largest examination of PFAS exposure and testicular cancer to date, by looking at the banked blood of Air Force servicemembers. It found those employed in fire protection had elevated concentrations of PFOS, a PFAS chemical, in their blood. Higher blood levels of PFOS were linked to testicular cancer.

It's the latest in a growing body of research tying PFAS to health effects, but despite widespread use of firefighting foam, and suspected contamination in the groundwater of hundreds of military bases, exposure to PFAS is not widely considered a service-connected injury, and sources tell Spotlight on America there's a lack of understanding and uniformity among medical providers.

"We're calling PFAS, the new Agent Orange," said Kevin Ferrara. "It's frightening because you look at what the DoD has done to veterans that were exposed to Agent Orange, they strung them along for decades until they finally recognized it."

Congress mandated that the Department of Defense offer blood tests to military firefighters to look for PFAS chemicals in 2020.

The first results were reported to Congress this year. Spotlight on America dug through the data, finding that more than 9,100 firefighters opted for a blood test in 2021.

You can read the full report to Congress below.

We took the results to PFAS researcher and former West Virginia University Professor Dr. Alan Ducatman.

"When you get to the 95th percentile, which is 5% of people, those exposures get to be quite high," Dr. Ducatman said. "There are some people with extraordinary exposures, and there's every opportunity to figure out what those people are doing and to think about the jobs and what may be leading to those exposures that could be backtracked, and public health could be improved."

Most of the blood tests performed, about one third, were servicemembers in the Air Force. The PFAS detected most often in the serum was PFOS, which was found in 95.6% of the samples.

Overall PFAS geometric mean blood concentrations ranged from a high for PFOS at 3.1 nanograms per milliliter (ng/mL), followed by PFHxS (2.8 ng/mL), PFOA (1.1 ng/mL), and PFNA (0.42 ng/mL).

In a 300-page report, the National Academies of Sciences suggested that 20ng/mL of PFAS in blood is serious enough to screen patients for signs of testicular cancer and other health effects.

Among the DoD's blood test results, levels of just one PFAS chemical at 150 ng/mL. That's more than seven times higher than the NAS designated level that could indicate potential health effects.

Still, the full extent of exposure in the military community at large is unknown.

Blood tests are only offered to active duty and reserve firefighters, not veterans or other servicemembers who may have worked with AFFF.

The VA's web site does not recommend blood tests, saying most Americans have PFAS in their blood and saying "blood tests cannot be linked to current or future health conditions."

Congressman Dan Kildee (D-MI) doesn't believe people understand the risk to veterans. He created the Congressional PFAS Task Force in 2019.

"We have not seen, whether it's in the VA or the DOD, we haven't seen the kind of urgency that we think should be applied to PFAS contamination," Rep. Kildee said. "I just don't think the the federal government is doing anywhere near enough."

For now, even with the results of a blood test in hand, we discovered military firefighters are fending for themselves.

Kevin Ferrara said he's spoken with firefighters left confused by their results.

"A lot of times they say, the doctor looks at them and says, 'I have no idea what this data means. Good luck.'" Kevin Ferrara said. "That's not what these firefighters need to encounter when they see a physician."

Dr. Alan Ducatman told us it's unreasonable to expect that all doctors are PFAS experts, but it's important for medical monitoring systems to be in place. "It would be good to get a cadre of doctors for the military and for communities who have had these elevated exposures who do understand the problem and who can help those community members."

Spotlight on America obtained guidance the military gave to its practitioners offering PFAS blood tests, telling them to inform patients “any follow-on health care or medical evaluations based on the PFAS laboratory result must be sought from their private healthcare at their own expense.”

Congressman Kildee calls that "unconscionable."

He's introducing legislation called the Veterans Exposed to Toxic PFAS Act, which would require the VA medical system to treat those cases as duty-related, to include high cholesterol, ulcerative colitis, thyroid disease, testicular cancer, kidney cancer and pregnancy-induced hypertension.

But the bill has not advanced.

"When a person puts on the uniform of the country, they accept certain risk," Rep. Kildee said. "But we also say to them, if you get injured, we're going to take care of you. We're gonna have your back. And the very idea that we have to pass legislation to codify a promise that I think is implicit is very frustrating to me."

It's frustration shared by Kevin Ferrara.

"Congress can make change within a day with a swipe of a pen," he said. "Every single day that Congress is sitting on this and arguing over whose name's going to be on the bill, who's going to sponsor it, who's gonna vote on it? We have veterans out there every day that are suffering from PFAS, and they're dying from this stuff."

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The VA told Spotlight on America it's reviewing new studies about PFAS. You can read our full Q&A with the VA below:

Q1. (VHA) Is the VA aware of the federal study that linked PFOS in service members to testicular cancer ? What is the VA’s response to that study? Is there discussion about how those findings may inform the treatment of military members?

A1. We are currently reviewing this study. Veterans who feel as though their health has been impacted by exposure to PFAS during their military service are encouraged to file a claim for disability benefits. These claims are considered on a case-by-case basis.

Q2. (VBA) Is the VA aware of legislative efforts to designate PFAS exposure as a service-connected injury? What is the VA’s response to those efforts, and does it plan to comply with the law if passed?

A2. We are closely monitoring the research regarding exposure of service members to PFAS. PFAS are synthetic chemicals that are contained in many products such as fire-fighting foams (aqueous film forming foams (AFFF)), clothing, furniture, food packaging, and may be contained in drinking water and certain foods.

While no presumptions have been established to date for any specific medical condition based on exposure to PFAS, a presumption is not required to establish service connection. VA makes decisions on claims based on exposure to PFAS or a specific source of PFAS, such as aqueous film forming foams, on a case-by-case basis. For example, for a Veteran filing a claim for disability due to exposure to aqueous film forming foams, VA reviews the facts and evidence such as the types, levels, and duration of exposure (if known), onset and nature of claimed medical condition(s) and other factors to determine if disability compensation is warranted. If there is an approximate balance of positive and negative evidence, VA gives the benefit of the doubt to the Veteran.

Our general policy has always been that disability compensation can be granted if a Veteran has a current disability that is related to his or her military service including disabilities related to in-service exposures like PFAS. Any Veteran who feels that military service has negatively impacted his/her health is encouraged to submit a claim for disability compensation.

Q3. (VHA) Does the VA recommend that military firefighters receive blood tests for PFAS, in light of the study finding that those employed in fire protection had elevated levels of PFOS?

A3. We are currently reviewing scientific information related to PFAS blood testing and the utility of such tests in a clinical setting. It has been established that a blood test for PFAS gives only a snapshot of what is in the body at that time; it cannot inform on when an exposure occurred, source of exposure, or current or future health outcomes. We will continue to discuss this issue and will review additional information as it becomes available. We are also actively working to address research gaps related to PFAS-related health outcomes in the following efforts:

A collaboration between VA’s Health Outcomes Military Exposures (HOME) program, Central Arkansas VAMC and Naval Health Research Center is leveraging assets from the Millennium Cohort Study to investigate PFAS levels in military firefighters (occupationally exposed) and construction workers (occupationally unexposed) as identified by military occupational specialty (MOS) codes. The study will also investigate correlations between PFAS levels and cardiometabolic outcomes and biomarkers.

A pilot study collaboration between HOME’s Exposure Science Program, Defense Centers for Public Health – Aberdeen and the National Institute for Environmental Health Sciences is to investigate and track PFAS exposures in active-duty firefighters via dried blood spots. Correlations with biomarkers of effect will be evaluated.

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Spotlight on America also posed a list of questions about blood testing to the Department of Defense. You can read their full responses below:

1) What is being done to analyze blood test results on a wide scale?

Response. Since October 2020, PFAS testing has been offered to all DoD firefighters during their annual physical exams as directed by Congress (Section 707 of the National Defense Authorization Act for Fiscal Year 2020). The PFAS testing offered to each DoD firefighter is directed in DoD Policy, “DoD Manual 6055.05-Occupational Medical Examinations: Medical Surveillance and Medical Qualification, Section 5.13”, available at https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/605505m.PDF?ver=3u-UoR7v7wydz-RIKQkI_Q%3D%3D. Currently, an individual’s PFAS levels cannot be used to predict adverse health effects and no occupational screening values for PFAS have been established. Exposure assessments and health studies are under way by organizations such as the Department of Health and Human Services (DHHS) Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances Disease Registry (ATSDR). They may inform whether screening values can be determined for PFAS in the blood of the general public and for occupational settings. Results from our analysis of DoD firefighters is included in the response to the second question.

2) Can your office provide data on what has been collected and found?

Response. PFAS levels in blood are the result of exposures from all sources: environmental, occupational, and use of consumer products. The presence of PFAS in DoD firefighter blood does not tell us how, where, when, or for how long a person was exposed to PFAS, and whether it was from firefighting or other sources of PFAS. The following six PFAS were tested in the blood of DoD firefighters from October 1, 2020 through May 1, 2023: perfluorooctanoic acid (PFOA); perfluorooctane sulfonate (PFOS); perfluorohexanesulfonic acid (PFHxS); perfluorononanoic acid (PFNA); perfluoroheptanoic acid (PFHpA); and perfluorobutanesulfonic acid (PFBS). Additional PFAS were added, beginning in May 1, 2023. Summary statistics for the first year of DoD firefighter blood testing can be found on https://www.health.mil/Reference-Center/Reports/2023/02/14/Perfluorinated-Chemicals-PFCs-Contamination-and-First-Responder-Exposure.

Analysis of results from samples collected from the second year of testing (October 1, 2021 through September 30, 2022) is currently underway. In addition to similar summary statistics, the DoD will include some initial trending information between the first and second year of offering tests to DoD firefighters.

Additionally, the DoD is currently planning to have future blood samples analyzed using the CDC’s analytical method. This will allow the DoD to reevaluate PFAS being analyzed and consider additional PFAS analytes to better align with those being analyzed by the CDC. The CDC indicates that their scientists found four specific PFAS (PFOS, PFOA, PFHxS, and PFNA) in the blood of nearly all of the people tested, indicating widespread exposure to these PFAS in the U.S. population. CDC data suggest that over 98% of Americans have detectable levels of PFAS in their blood. The data tables showing PFAS blood testing results for the general population since 1999 can be viewed at: https://www.cdc.gov/exposurereport/.

3) What examinations are underway?

Response. The DoD is collaborating with other Federal agencies that are leading efforts associated with the completion of environmental and occupational exposure assessments, risk assessments, and health studies. The ATSDR and CDC’s National Institute for Occupational Safety and Health (NIOSH) are conducting health and exposure studies to understand PFAS exposure pathways from environmental and occupational PFAS sources, and whether these exposures are linked with potential health outcomes. The results of these studies will inform the development of exposure assessments, occupational exposure limits and medical surveillance requirements for the DoD. In addition, the Department will update its guidance to DoD healthcare providers when ATSDR revises their PFAS clinical guidelines.

4) How many of these blood tests have been performed?

Response. DoD records indicate that in Fiscal Year (FY) 2021, 10,208 DoD firefighters were offered a blood test for PFAS as part of their existing annual firefighter occupational medical surveillance exam. Of these, 9,104 DoD firefighters chose to have their blood tested and 1,004 DoD firefighters opted not to have their blood tested. A complete analysis of recent (FY2022 and beyond) blood testing data is ongoing and unavailable at this time.

HUNTINGTON — The Gateway Regional School Committee is working on a new visitor policy that will permit the School-Based Health Center, run by the Hilltown Community Health Centers, to allow some adult patients to come in during school hours.

The request was made by the lead family nurse practitioner at the school clinic, Brenda Chaloux, in order for her to be able to continue seeing some of her Hilltown patients. Chaloux is at school during clinic open hours from 7:30 a.m. to 3 p.m.

The clinic provides immunizations, physical exams, emergency care, first aid, prescriptions, mental health counseling, nutrition counseling, optometry services, sick visits and rapid in-house testing for Gateway students.

The school-based health clinic is separate and in addition to school nurses that Gateway has on staff.

At the School Committee meeting on Nov. 8, Lyndsey Papillion of Russell, who serves on the Policy Subcommittee, said subcommittee members had hashed out a new agreement that addressed some of the concerns they had, the biggest of which was security.

Papillion said Chaloux would escort community members to and from the door and check identification for visits to the clinic. She said according to Chaloux, on some days she sees 10 students and on other days, two students.

The new policy would undergo a quarterly review by Superintendent Kristen Smidy, who said she would make sure it does not take away from student care, and that the clinic would still be available to students during emergencies.

“We need to ensure that students and staff are secure in the building,” she said, adding that the school also wants to ensure that the rural community has access to health care.

The clinic currently conducts wellness visits by appointment with students. Chaloux said four to five community members might use the clinic per day. Papillon said among her patients are many staff members and parents who are already vetted by the schools. On an average day, the clinic might see four adults and six students, for example.

Papillion said the School Committee would have to vote to accept the policy every year. If health clinic personnel change, there would be an immediate review of the policy.

“Gateway is the hub of the community. If we can make it work, we can keep Brenda as a valuable asset,” Papillion said.

“It’s the perfect storm of the right people at the right time,” said committee Chair Sarah Page, adding, “If it was going to work, these are the people we would need in place.”

During the discussion, a question was asked if the committee had considered limiting the adult patients to those who always have access to the school building. They said to a certain extent, many of the patients are already vetted, but the school won’t have full access to the patient list. Gateway will provide the clinic with its trespass list.

School Committee Blandford representative Nicole Daviau said the school is open to the public for performances, Council on Aging lunches and other events. She said she was confident in the policy of having Chaloux walk patients to and from the door.

Chester representative Jeanna Briggs said she had just come from the basketball tryouts, at which 40 to 50 parents were in the building.

“I think you did the best job you could. Sounds great,” Briggs said.

Jason Forgue, another Chester representative, asked if current practice allows any teacher in the building to have any adult visitor they want.

Assistant Superintendent Stephanie Fisk said volunteers that work directly with students must pass a criminal record check.

Daviau said that visitors are under the purview of teachers, such as the people helping with a recent flower sale. Fisk said 99% of the people who came to sort flowers are the people who chaperone trips.

Forgue said he studied the grant agreement with the health clinic, and could not find any mention of services for anyone other than the students. Smidy said the grant specifies that staff should be on site and available to students, but is silent on whether the staff can also see other patients.

Page said the permission is being sought by Chaloux, who said she is committed to the school-based health center, and won’t be adding any adult patients to her caseload. According to committee members, Chaloux said if she is not permitted to see her patients from the community, she would have them see other health care providers.

Forgue asked the committee what would determine when the new policy is not working. Papillion said if there is a security breach, if students are not getting seen, or if the current Hilltown Community Health Centers staff resigns. Smidy suggested adding to the policy that it could be shut down for any reason at any time.

The committee voted to approve the policy with the suggested changes.

Reflecting on his 10 years as CEO of the medical device play – a milestone achieved last month – Michael Kavanagh says the numbers tell the story.

A decade ago, Nanosonics (ASX:NAN) turned over $14.8 million, two years after its Trophon probe sterilisation device was approved in the US. The company also lost $5.8 million.

Fast forward to 2022-’23 and the company posted $166 million of revenue and made a net profit of just under $20 million.

Kavanagh adds the numbers tell only part of the story.

“The part I’m most proud of is the amazing capabilities we have built into the business,” he says.

“We are one of a handful of labs in the world today (with expertise) in biofilm on medical devices, especially in very small lumens of less than one millimetre in diameter.

“We have had to build capabilities in biosciences, microbiology and chemistry.”

Having Trophon-ized hospitals around the world – especially in the US – Nanosonics is poised to commercialise its second instrument, called Coris (see below).
 

Tackling hospital infections

Based in Sydney, Nanosonics was founded in 2001 by microbiologist Dr Ron Weinberger and engineer Stuart Hodgetts, who were inspired by the need for hospitals to reduce infections caused by poorly-cleaned medical devices.

The first device iteration was the Trophon EPR – as in Enhanced Protection and Reprocessing – which uses hydrogen peroxide vapor to disinfect ultrasound probes much more thoroughly than the old manual methods.

Nanosonics claims the Trophons protect 98,000 patients daily from ultrasound probe cross contamination – or 25 million a year.

Hey! That’s almost the size of Australia’s population.

Nanosonics listed in May 2007, raising $27 million at 50 cents apiece.

The company launched the Trophon EPRs in 2009 and the pimped-up Trophon 2s in 2018.

The US Food and Drug Administration (FDA) approved the Trophons in 2011.

Previous to his decade-long Nanosonics gig, Kavanagh was marketing head honcho at Cochlear.

Another key contributor is Maurie Stang, who chaired the company from 2007 until July last year.

On October 3 this year, long-time chief financial officer McGregor Grant stepped down, in favor of former local GE Healthcare CEO Jason Burriss. Grant has since won a board seat on, and is chair of, device play Impedimed.

A notable recent Nanosonics board addition is Dr Larry Marshall, the sometimes-controversial scientist and entrepreneur who headed CSIRO for more than eight years.
 

Germs gone with Trophon

About the size of a microwave, Trophons sanitise probes to certified high level disinfectant (HLD) standards.

The units protect against nasty bugs including drug-resistant bacteria, fungi, blood-borne viruses, venereal diseases and – if anyone still cares – Sars-Cov-2.

The Trophon process takes seven minutes and produces harmless water and oxygen as a byproduct of the disinfectant hydrogen peroxide.

Pre-Trophon, sterilisation standards have ranged from a quick ‘once-over’ with a cloth to a procedure involving an isolating room with dangerous chemicals.

As well as selling (or leasing) the units, Nanosonics also makes money from servicing and consumables. The latter consists mainly of the hydrogen peroxide canisters that are used in the procedure (rather like a dishwasher powder tablet).

In the US, the Trophons were distributed exclusively by GE Healthcare. But this arrangement was revised and the company now mainly sells directly.
 

Hospitals are doing it hard

Nanosonics continues to grow its base of Trophons – albeit at a slower run rate than pre-pandemic.

“Our customers [hospitals] are experiencing one of the most difficult operating environments for a very long time,” Sargent told last week’s AGM.

“Costs are rising at a faster rate than revenue and governments have increasing budgetary pressures.”

As of June 2023, Nanosonics had an installed base of 32,450 Trophons, up nine per cent for the year and 55 per cent higher than five years ago.

Of these, 28,390 are in the US (up nine per cent). Europe and the Middle East account for a further 2,100 (up 10 per cent) and Asia Pacific (mainly Australia) another 2,050 (up eight per cent).

The full-year accounts show 2,600 newly installed Trophons, down 16 per cent year-on-year.

But there were 1,800 upgrades from Trophon to the bells-and-whistles Trophon 2. These units include enhanced audit features to enable hospitals to keep up with ever-stricter compliance requirements.
 

Coris takes a flexible approach

A new product, Coris, is intended for flexible probes commonly used in procedures such as colonoscopies, gastroscopies, enteroscopies, endoscopic ultrasounds and bronchoscopies.

They have more fiddly bits than rigid endoscopes and are harder to clean, a process requiring scrubbing and long hours of standing.

As a guide, up to 200 manual actions are required (such as brushing and flushing) to clean the instruments. Because the channels can be one millimetre in diameter, “extensive biofilms” – that is, gunk – remain after cleaning.

Cleaning the probes costs $US11 to $US37 each – more than mere lunch money.

Coris delivers a “novel sonicated mist” that penetrates probe surfaces including the body handle and all crevices, thus reducing the risk of pathogens.

As with the Trophons, the Corises emit harmless oxygen and water.

The company says 60 million endoscopies are done each year in the US, Europe, and Australia, with gastroscopies (especially colonoscopies) accounting for 45 million.

Kavanagh expects Coris to have “at least the same” financial impact as Trophon, although the revenue from capital (equipment) sales are likely to be lower.

That’s because the Corises are placed centrally, rather than at the point of care (as with the Trophons). But the units are likely to be used more, resulting in higher consumables income.

“With Coris we clearly understand the problem and have been able to innovate in a very complex area,” Kavanagh says.
 

Star-spangled spanner in the works

Not for the first time, the FDA recently showed “it’s my way or the highway” by demanding that testing of Nanosonics’ key new product, Coris, be carried out on its shores and not here.

An FDA submission under the agency’s de novo (novel device) route is now expected in the March quarter of 2024.

Kavanagh says the FDA wanted to see more work in relation to “human factors” – that is, ensuring the instrument can be easily used and not misused.

He says the FDA’s demands were a blessing in disguise: “It’s lot better to know [the requirements] before you submit for approval, rather than to have to go back and re-do them.”

Nanosonics is part of the FDA’s Safer Technologies Program (Step), a ‘concierge’ style process to Strengthen communication with the agency and streamline the route to approval.

“The review does not bypass statutory requirements or make it faster, but it certainly helps the cause,” Kavanagh says.
 

Finances and performance

Consolidating its post-pandemic recovery, Nanosonics reported revenue of $166 million, 38 per cent higher, in the year to June 2023.

Net profit surged 431 per cent to $19.9 million. Adjusted to exclude expenditure on growth initiatives, earnings from the existing sales grew 175 per cent to $32.5 million.

At August’s full-year profit, management guided to 15 to 20 per cent revenue growth in 2023-’24.

At last week’s AGM, management declined to update the current-year outlook, given only four months of it had elapsed.

The 2022-’23 research and development bill amounted to $29.5 million, up 32 per cent and attributable mainly to the Coris program.

The R&D spend accounted for 18 per cent of revenue, compared with the industry standard of 12 per cent. But Kavanagh says this proportion will decline as the company matures and grows its revenue.

Capital sales (that is, Trophon units) accounted for 67 per cent of total revenue ($54.2 million, up 44 per cent), with consumables (the cartridges) and service income accounting for the rest (112 million, up 35 per cent).

Over the last 12 months, Nanosonics shares have traded between $3.28 (mid-October 2022) and $5.80 (late April this year).

They peaked at a record $8 in December 2020 and have traded as low as 18 cents (November 2018).

Nanosonics stock share price today

What the brokers say

Broker Wilsons’ Nano-watcher Dr Shane Storey says the company’s full-year earnings beat expectations, but the Coris delay announcement was “clearly the biggest disappointment”.

He notes the “ongoing dismay of investors who have long awaited Nanosonics’ second product”.

The firm chalks in a modest $12.8 million of inaugural Coris revenue in the 2025-’26 year.

Dr Storey still rates Nanosonics as “overweight” – which is current stockbroker-marketing-speak for “a buy” – but has downgraded his valuation from $6 to $5.46.

RBC Capital Markets concurs the profit was okay, but lower-than-expected new Trophon sales, the Coris delay and weak guidance were all negatives.

For its two bobs’ worth, Citi rates the stock a sell, with a revised valuation from $4.20 a share to $3.90.

“It remains unclear when markets outside the US will become material,” the firm harrumphs.
 

Dr Boreham’s diagnosis:

Is Nanosonics undervalued?

Kavanagh notes the Trophon business generated a pre-tax profit of $44 million, which means the company would be wildly profitable if it simply stopped investing in new products.

The installed Trophon base is still ticking up and with the average unit now seven years old, more users will be angling for an upgrade.

Management cites an “installed base opportunity” of 140,000 units: 60,000 in the US, 40,000 in Europe/Middle East and 40,000 in Asia Pacific.

If Crucible’s slide rule is correct, Nanosonics has a 23 per cent overall market penetration. But this is skewed by a market share approaching 50 per cent in the US and only five per cent in Europe and the Asia Pacific (albeit with 85 per cent saturation of the Australian market).

Not surpassing, the company is ramping up its sales efforts in the UK, Ireland, and Germany, while it’s got more than a weather eye on the germ-obsessed Japanese market.

One broker opines the company is “catalyst-less” until Coris gets to market – a claim with which Kavanagh can’t agree.

“The growth prospects for the business for Trophon alone are still quite robust and the business continues to evolve,” he says.

As one market luminary – possibly Warren Buffett – once said: the share market is the transfer of wealth from the impatient to the patient.

On that note, Nanosonics’ 15 per cent share slide since its financial results might present an opportunity for the true believers.
 
The views, information, or opinions expressed in the interviews in this article are solely those of the interviewees and do not represent the views of Stockhead. Stockhead does not provide, endorse or otherwise assume responsibility for any financial product advice contained in this article.

Disclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. But he likes to think he posits probing questions while keeping clean at the same time.