In the effort to save lives and find another safe and effective COVID-19 vaccine, Stony Brook Medicine is participating in a Phase 3 clinical trial to test the safety and effectiveness of a Novavax investigational vaccine for SARS-CoV-2, the novel coronavirus that causes COVID-19.
Stony Brook is the only Long Island site participating in this clinical trial, and one of two in New York State to be selected for the trial.
The study began on Dec. 27 and is led locally by principal investigator Benjamin J. Luft, MD, Edmund D. Pellegrino Professor of Medicine at the Renaissance School of Medicine at Stony Brook University, and Adult Infectious Diseases Expert; and Sub-Investigator Sharon Nachman, MD, Professor of Pediatrics and Associate Dean for Research at the Renaissance School of Medicine. The randomized, blinded placebo-controlled phase III clinical trial will assess the immunity and safety of the Novavax vaccine candidate, as well as its ability to reduce disease in those who contract the virus.
Sponsored by the National Institutes of Health’s (NIH) COVID-19 Prevention Network, the study will recruit up to 30,000 participants at multiple sites across the U.S. and Mexico. Stony Brook is expected to enroll 500 participants, with the vaccine distributed mainly through Stony Brook Medicine’s Advanced Specialty Care in Commack, because of its ease of access and on-site phlebotomy and pharmacy.
Stony Brook was chosen as a trial center, in part, because of the institution’s outstanding expertise in infectious disease research – including vaccinology – and for the ability to perform clinical trials in subjects with complex medical conditions. The study will leverage Stony Brook’s extensive relationships with the first responder and essential worker communities to offer the vaccine trial to those at particularly high risk. Additionally, Stony Brook aims to bring the vaccine trial to underrepresented populations who are also at higher risk for infection.
The clinical trial is a pivotal phase-three study, following phase one and two trials, in which volunteers produced strikingly high levels of antibodies. The results from the phase one study were published in the September issue of The New England Journal of Medicine. There are many benefits to participating in the study:
Level of antibody production. Based on Novavax’s phase two study, patients who received the investigational vaccine have reached protective levels of antibody production lasting for as long as they have been followed in the clinical trial.
Two-to-one randomization. The clinical trial is a two-to-one randomization of an investigational vaccine compared to placebo (most vaccine studies are one to one). This means that for every two people who receive the vaccine candidate, one will receive a placebo — increasing a participant’s chances of receiving the vaccine candidate.
Follow-up and monitoring. Each participant will be monitored for a two-year period. This will allow for a long-term safety assessment of all participants in the clinical trial.
Participants must be enrolled over a six- to eight-week period. They must be over age 18 and have not previously tested positive for COVID-19. At least twenty-five percent of participants must be 65 years of age or older. Those who are more likely to have an increased risk of SARS-CoV-2 infection due to community exposure, such as working in jobs that requires public interaction, are encouraged to participate.
Participants must be in reasonably good health, including those who have preexisting conditions, such as high blood pressure, diabetes or heart disease, that are stable. The investigational vaccine is not live, so participants cannot become ill with COVID-19 as a result of receiving the vaccine candidate. Enrollees are encouraged to have gotten their flu vaccine prior to enrolling in the study. All vaccines, including the flu vaccine, must be received at least four days prior to, or seven days after, receiving any study-related injections.
For more details about the clinical trial and Novavax, see this link.
Cars line up at the Stony Brook coronavirus testing site. Photo by Kyle Barr
New York State has partnered with Stony Brook University to provide drive-through testing for the coronavirus at Stony Brook University’s South P Lot off Stony Brook Road. Residents must make appointments in advance by phone at 888-364-3065 or online at covid19screening.health.ny.gov.
Hours of Operation
Monday through Friday, 8 am to 6 pm
Saturday and Sunday, 8 am to 3 pm
Please note: The hours of the testing site during the New Year’s Day holiday are as follows:
Thursday, Dec. 31: 8 am to 6 pm
Friday, Jan. 1: Closed
Saturday, Jan. 2: 8 am to 5 pm
Sunday, Jan. 3: 8 am to 3 pm
Anyone who believes they’re at risk should call the Department of Health Hotline, 888-364-3065, and talk to experts to determine if and how they should be tested.
Walk-ins are not accepted and will not be seen.
All test results will be provided by the Department of Health. Call the DOH Hotline at 888-364-3065.
Click here for a map and directions to the testing site.
St. Catherine Chief Nursing Officer Mary Jane Finnegan gives a flu shot during a free mobile clinic at the end of September. Photo from St. Catherine hospital
They lost patients, sleep and time with their families and yet, through some of the most difficult conditions in over a century, they persevered, brought together by the shared goal of saving lives threatened by the pandemic.
The Times Beacon Record Newspapers is pleased to honor the health care workers who put themselves in harm’s way to offer comfort, cures and solutions for COVID-19.
State Sen. Jim Gaughran (D-Northport) described health care workers as “heroes beyond belief.” He added, “There are folks who have gotten sick and died, simply because they were just doing their jobs.”
Unusual Requests
Indeed, in some cases, these health care workers took on tasks that aren’t typically a part of their job description or training.
Tricia Coffey on the phone at Huntington Hospital. Photo from Coffey
Take Kristen Thomas, a registered nurse at Mather Hospital in Port Jefferson. A priest came up to her in the halls of the hospital to ask for an unusual favor. A person had died and the family, who couldn’t be by his side, asked for last rites. The priest knew he couldn’t enter the room.
He asked, “Would you mind taking holy water and anointing the patient?”
She approached the patient, made the sign of the cross and prayed, as the priest stood outside the door.
“A moment like that, you never really plan to do that,” Thomas said. “We tried to give the family a little bit of closure. They didn’t get to attend the normal [rituals].”
For the community and health care workers, normal took on new meaning, especially in the first few months of the pandemic, when Suffolk County became an epicenter of the virus.
With family unable to sit by the bedside, nurses often stepped up, holding up iPad and phones so the family could spend time together virtually.
Marilin Dilone, Emergency Department nurse at Stony Brook University Hospital, called the young family of one of her patients.
Marilin Dilone, emergency department nurse at SBUH decked in full PPE gear. Photo from SBUH
His wife “put the baby on the phone — the baby looked like he was maybe 10 months old. The baby was making noises. I swear [the patient] opened his eyes. The wife is crying. Such a moment, we take for granted. He could hear her say, ‘I love you.’ To be able to provide that was very humbling for me.”
Like Dilone and so many other nurses, Robert Collins, a nurse at Mather Hospital ,shared how he held an iPad up to patients whose conditions were deteriorating so they could say goodbye to their families.
He had to stay in the room because some of the patients couldn’t hold the iPad.
“You do that once or twice, it kind of sticks with you,” Collins said.
Deep Connections
The connections the medical staff made to the families of patients extended well beyond the typical interactions.
“We had patients for an extended period of time,” said Patricia Coffey, nurse manager of the Critical Care Unit at Huntington Hospital.
Coffey, who spent 11 weeks actively caring for patients as her managerial duties “went to the wayside,” said the staff talked to families for extended periods of time. She spoke with some families daily, spending as much as two-and-a-half hours each day on the phone.
The nurses felt like members of the family because the normal support system couldn’t provide bedside support.
“You were channeling the family to the patient,” Coffey said. The nurses were “rooting so hard” for the patients.
When one of those patients who was in the hospital died after a long battle, she said it was “unbelievably heartbreaking — you felt like one of your own family members had died.”
She still keeps in touch with family members.
Mather Nurse Robert Collins. Photo from Mather
Coffey said one of her neighbors was admitted to the hospital with COVID and was on her floor. Coffey’s children and her neighbor’s children grew up together and their daughters were friends.
She not only spoke with his wife every day during her 60-hour weeks, but she also called her coworkers over the weekend to ask how he was doing.
The conversations with the neighbor’s wife were “a little hard. I wanted to be honest with her. He was very critical. At the same time, I was trying to be hopeful. It was a hard balance.”
Coffey said he was “one of the lucky ones who survived.”
Dilone of SBUH described how the work was more physically demanding.
She would “try not to ask for people” as she didn’t want to expose others if it wasn’t necessary. “You are taking care of patients more by yourself, turning them and doing chest PT [physiotherapy] — it was physically more demanding,” Dilone said.
Dark Moments
Watching patients who died took its toll, even on people who have been in the medical profession for decades.
MaryJane Finnegan, chief nursing officer at St. Catherine of Siena Medical Center in Smithtown, described the unusually high number of people dying from the virus. The hospital was running out of space for the dead. The morgue was filled and an additional refrigeration truck outside also filled quickly.
Mather Nurse Kristen Thomas. Photo from Mather
“One day, eight people died — usually in a week, you can have eight people die, but not eight in a day,” Finnegan said.
Nikki Fiore-Lopez, chief nursing officer at St. Charles Hospital in Port Jefferson said a nurse was present for the death of her mentor. Watching her die was “one of the darkest moments” for the nurse, Fiore-Lopez said.
Many medical professionals encouraged their patients to fight through the worst of the virus.
Stony Brook’s Dilone stayed with a patient whose blood oxygen level kept dropping. She wouldn’t let him fall asleep because she was worried he’d get intubated. She reminded him of his family and that he needed to help himself.
“I felt like Nurse Ratched,” Dilone said, referring to the dreaded nurse from the movie “One Flew Over the Cuckoo’s Nest.”
Dilone spent hours with this patient. Later, a doctor told her keeping the man awake prevented him from getting intubated.
Unexpected Challenges
With a virus no one had battled before, health care workers had to be flexible, learning about everything from new protocols for admitting patients to the latest and best treatments.
Chief Nursing Officer at St. Charles hospital Nikki Fiore-Lopez delivers flowers to patients at Christmas with Foundation Board Chair member Doug Casimir in 2019. Photo from St. Charles
The staff had to confront the “speed with which everything changed,” said Dr. Eric Morley, associate professor and clinical director in the Department of Emergency Medicine at Stony Brook University’s Renaissance School of Medicine. “Every day, there were new protocols, new ways to deal with things.”
Hospitals had to create a forward triage system to deal with the flood of COVID patients amid all the other potential emergencies hospitals routinely have.
These efforts required hundreds of employees to “get on the same people to sort people out,” Morley said. Training staff to manage the flow of patients required constant communication.
Even some of the smaller elements of managing the crisis took Morley’s time, such as getting new traffic signs to direct people to an alternate site.
Hospital managers were continually confronted with numerous unexpected challenges.
Ken Roberts, president of Mather Hospital, said the hospital had to ensure the PPE was hospital grade and not counterfeit.
“There were a lot of suspicious and unscrupulous suppliers when supply and demand was unbalanced, and everyone was in crisis,” he explained in an email.
Health care workers tapped into their personal skills to connect with patients.
Angel Figueroa, a registered respiratory therapist at SBUH who grew up in New York City and learned Spanish thanks to his Puerto Rican heritage, walked into some rooms and spoke Spanish to patients.
When he greeted patients in Spanish, “I would see their eyes open up [and think], ‘Somebody understands me.’”
They would ask him numerous questions, particularly because the medical information came at them so quickly.
Mather’s Collins described how the routine changed so dramatically the moment he arrived at work.
Mather President Ken Roberts holds a sign thanking health care workers. Photo from Mather
“Rapid response bells were going off as soon as you walked in,” he said. “You didn’t take your coat off” before patients needed attention. “People were not doing well. That was happening more frequently than before. That was an adjustment.”
On the other side of the struggle, health care workers felt a tremendous sense of relief when patients continued their recoveries at home.
“When people were discharged, the staff was thrilled,” St. Catherine’s Finnegan said. “We’d play the [Beatles] song, ‘Here Comes the Sun.’ A lot of hospitals did that. People would gather as many as possible to wish the person well as they were wheeled out.”
Teamwork
Through the difficulties, though, Morley appreciated the support from the community and the families, along with the teamwork and camaraderie from so many departments and staff that all pulled together.
Roberts expressed similar sentiments.
“I was extremely pleased at the teamwork displayed by all hospital staff during the height of the pandemic,” he said.
The Mather president was also grateful for the letters, cards, donated meals, handmade masks and donated PPE.
“The local communities we serve gave us and continue to give us tremendous support and encouragement,” Roberts said. “That has meant so much to the staff to know that the community was supporting them and recognizing their efforts.”
Stony Brook Respiratory Therapist Angel Figueroa wearing mask and shield. Photo from SBUH
Coffey, from Huntington Hospital, was impressed with how, even amid such extraordinary and challenging times, numerous groups collaborated.
“In many ways there were positive things — the community, the team, everyone working together,” she said. “Parts of it were so uplifting. As hard and as difficult and sad and heart wrenching [as it was], so many other parts, you just saw such humanity. It was amazing.”
Lasting Thoughts
Finnegan said the staff was incredibly appreciative of all the food local restaurants donated.
In fact, some of them joke that they gained the “COVID-19,” referring to the weight they put on while they were working numerous shifts and benefiting from all the donated food.
Morley “rediscovered” Twinkies during COVID in the break room. He has since been able to lose the weight the snack cakes added.
While gyms were closed, Collins relieved stress by buying a 400-pound tractor-trailer tire that he flipped up and down along his driveway. He also took a sledgehammer and “beat on it.”
The exertion would make him tired enough that the stress would dissipate for the day.
Dr. Eric Morley from SBU participates in COVID testing. Photo from SBU
Ultimately, what made an ever-expanding job — that affected so many aspects of health care workers’ personal and professional lives — manageable was the shared sense of purpose and the inspiration people drew from each other.
“The fact that the staff was out there doing it” helped give her energy, St. Charles’ Fiore-Lopez said. “We had patients to care for, we had shifts. We had days and weeks and months to get through. They put one foot in front of the other and I needed to do the same.”
Morley appreciated the way the Stony Brook staff pulled together during an intense and challenging time.
“Although it was grueling, it was a special thing to go through with that group of people,” he said.
Resolutions that focus on health and fitness are made each year. Numerous people are eager to lose weight, improve their physical fitness levels or even stop habits that can hinder their mental or physical wellness.
People have many options when they seek to lose weight. Fad diets may promise quick results, but highly restrictive eating plans or marathon workout sessions can be dangerous. Taking shortcuts or risks in the hopes of losing weight can lead to various health issues and ultimately put people’s overall health in serious jeopardy. Thankfully, there are many safe ways people can lose weight. The first step in safe weight loss is to visit a doctor and let him or her know your plans. The doctor can help determine if a specific eating plan or exercise routine is safe based on your current health.
Certain medications can affect metabolism and even contribute to weight gain, so a discussion with the doctor can help ensure people aren’t putting their health in jeopardy when their goal is to get healthy. It’s also vital that people trying to lose weight do not believe everything they read online.
Research published in The American Journal of Public Health in October 2014 found that most people who search the internet for tips on how to lose weight come across false or misleading information on weight loss, particularly in regard to how quickly they can shed some pounds. The Centers for Disease Control and Prevention advises the safest amount of weight to lose per week is between one and two pounds. People who lose more per week, particularly on fad diets or programs, oftentimes are much more likely to regain weight later on than people who took more measured approaches to losing weight.
In addition, the Academy of Nutrition and Dietetics notes it is better to lose weight gradually because if a person sheds pounds too fast, he or she can lose muscle, bone and water instead of fat. The calories in, calories out concept is something to keep in mind when attempting to lose weight. But metabolism and other factors, including body composition and physical activity levels, also are factors. How well one’s body turns calories into fuel also needs to be considered. The best ways to experiment are to start slowly. • Calculate the average daily calories consumed in a day using a tracker. This can be a digital app on a phone or simply writing down calories on a piece of paper. Track over a few days and see, on average, how many calories you’ve been consuming.
• Notice extra calories. Many diets can be derailed by eating extra calories that you don’t realize you’re consuming. That cookie a coworker insists you eat or the leftover mac-and-cheese from your toddler’s plate can be sources of extra calories. Be mindful of what’s being consumed, including sweetened beverages.
• Explore the science. According to the Scotland-based health service NHS Inform, one pound of fat contains 3,500 calories on average. Cutting calorie intake by 500 calories per day should see you lose 1 pound per week. The same goes in the other direction. Eating 500 more calories per day for a year can result in gaining close to 50 pounds. Small changes really add up.
• Eat filling foods. Choose low-calorie, high quality foods, like vegetables, whole grains and lean proteins. Meals that provide satiety can help eliminate between-meals snacks that can derail your weight loss efforts.
• Seek support as a way to create accountability. Share weight loss plans with a friend or relative who can help monitor your progress and keep you on track.
• Incorporate strength training. Good Housekeeping says the more lean muscle you have, the faster you can slim down. Start slowly with strength training, using free weights or body weights. Aim for strength workouts three to four times per week and alternate with calorie-blasting cardio. Explore safer ways to lose weight, including taking a gradual approach that promotes long-term weight loss.
Corals in the Gulf of Aqaba in the Red Sea. Photo by Maoz Fine
A paper published in Frontiers in Marine Science on December 15 is calling for action to remove the oil from a decaying and inactive tanker in the Red Sea that holds approximately one million barrels of oil – four times the amount of oil contained in the Exxon Valdez, the tanker that had a disastrous environmental oil spill in 1989 – before its current seepage turns into a massive oil spill into the sea. The paper, a policy brief, is authored by a team of international scientists led by Karine Kleinhaus, MD, MPH, an Associate Professor of the School of Marine and Atmospheric Sciences (SoMAS) at Stony Brook University.
Scientists produced a computer simulation of the spread of oil from the abandoned tanker in the Red Sea. The projection shows mass spread during winter compared to summer due to current patterns. The data shown was produced by running the model for 30 days. Oil spread even further from the tanker when the model ran for a longer period of time. Photo from SBU
Called the Safer, the tanker is a floating storage and offloading unit (FSO) abandoned for years, and with access controlled by Yemen’s Houthis. The paper, titled “A Closing Window of Opportunity to Save a Unique Marine Ecosystem,” comes shortly after The New York Times reported on November 24 that the Houthis will grant permission to a United Nations (UN) team to board the Safer to inspect and repair the vessel in the near future.
“The time is now to prevent a potential devastation to the region’s waters and the livelihoods and health of millions of people living in half a dozen countries along the Red Sea’s coast,” says Dr. Kleinhaus. “If a spill from the Safer is allowed to occur, the oil would spread via ocean currents to devastate a global ocean resource, as the coral reefs of the northern Red Sea and Gulf of Aqaba are projected to be among the last reef ecosystems in the world to survive the coming decades.”
She explained that the reason the coral reefs of the northern Red Sea are unique is because they survive in much warmer waters than today’s ocean temperatures, which are becoming too high for most coral to tolerate (over half of the Great Barrier Reef has degraded due to marine heat waves caused by climate change). Additionally, the fish living on the reefs off Yemen in the southern Red Sea are a major resource of food for the populations of the region, and the entire sea and its coral reefs are a highly biodiverse and rich ecosystem.
Dr. Kleinhaus and co-authors point out that in May 2020 seawater breached the Safer and entered the engine compartment, and news agencies have reported oil spots next to the tanker, indicating likely seepage. The tanker has been abandoned since 2015, which the authors emphasize is a long advance warning of a decaying tanker poised to degrade to the point of a mass oil leak into the Red Sea.
The paper reveals a computer model of how the oil will disperse if a major leak begins this winter. The model shows that the oil will reach much further if the spill occurs now rather than in summer, due to the typical winter currents in that region of the Red Sea. A spill now will cause much broader and more extensive devastation as a result.
Despite the signs of the Safer’s structural deterioration, access to the tanker has yet to be achieved and concrete steps to repair or to prevent an oil spill have yet to been taken, the authors point out. Dr. Kleinhaus adds that winter is the worst time to have an oil spill in that region, as winter currents will disperse oil much more widely.
The authors urge that “Emergent action must be taken by the UN and its International Maritime Organization to address the threat of the Safer, despite political tensions, as a spill will have disastrous environmental and humanitarian consequences, especially if it occurs during winter. With millions of barrels of oil, a day passing through the Red Sea, a regional strategy must be drafted for leak prevention and containment that is specific to the Red Sea’s unique ecosystems, unusual water currents, and political landscape.”
Fotis Sotiropoulos displays a slide during Zoom presentation. Photo from Stony Brook University
The CDC has issued its strongest mask guidance yet during the COVID-19 pandemic, calling for “universal mask wearing” in all activity outside of one’s home. The new guidance lists “universal wearing of face masks” as the first recommendation to help stop the spread of the disease. It says masks should be worn for all indoor activity outside of an individual’s home, as well as during all outdoor activity when at least 6 feet of social distancing can’t be maintained.
“Larger, heavy saliva particles can in fact settle within the recommended six-foot CDC guidelines and could contaminate surfaces. However, the greater concern is the smallest particles, or “aerosols,” that can be transported by the airflow several feet away from the body and stay suspended for longer periods of time,” said Sotiropoulos.
“A virus is primarily spread by respiratory droplets produced by exhalation. As we exhale, sneeze and cough it creates a range of particles at a range of scales,” said Sotiropoulos. “Airborne transmission occurs more easily when droplets are very small and stay suspended for a long period of time and can be inhaled and penetrate lung tissues, which is the case with coronavirus.”
These findings led a team in the Department of Civil Engineering, including assistant professor Ali Krosronejad, research associate Christian Santoni and PhD students Kevin Flora and Zexia Zhang, to study the effectiveness of social distancing and face coverings.
The research used computational fluid dynamics modeling for coughing and breathing, indoors and outdoors, with masks and without. High-fidelity numerical simulations of respiratory particulate transport on high-performance supercomputers provided strong evidence that even the simplest masks are effective in protecting others by dissipating the forward momentum of expiratory jets, especially in indoor environments. The details of the study were published in a paper, entitled “Fluid dynamics simulations show that facial masks can suppress the spread of COVID-19 in indoor environments,” in American Institute of Physics (AIP) Advances.
“The difference is stunning,” Sotiropoulos said. “Masks can modify the structure of a cough and dramatically diminish its energy and forward propagating momentum. The bottom line is: Wear a mask, any mask, and stay six feet apart to both protect yourself and others around you.”
With flu season’s arrival amid the coronavirus pandemic and public division over preventative protocols, residents and staff of the Gurwin Jewish Nursing & Rehabilitation Center in Commack took matters into their own hands, launching their first-ever Public Service Announcement (PSA) educational campaign. The 45-second PSA video highlights simple everyday practices to keep illness at bay while the nation awaits the rollout of the COVID-19 vaccine.
Preventing the spread of illness in the elderly population is critical, and during the current crisis has taken on more urgency. Mitigating the flu through vaccine and personal hygiene habits has been shown to reduce sickness and hospitalization, this at a critical juncture when healthcare resources are strained due to the pandemic. Calls to “Wear a mask,” “Wash your hands” and “ Do your part” can be heard throughout Gurwin’s “Stop the Spread” video campaign from both employees throughout the 460-bed nursing home, as well as the residents themselves, who are among the most vulnerable. Social distancing and flu shot recommendations are also voiced by campaign participants.
Huntington Hospital has been recognized with American Heart Association’s Mission: Lifeline gold plus award for its high-quality care of people with severe heart attacks. The hospital earned this distinction by providing life-saving, time-sensitive patients who experience ST Elevation Myocardial Infarction (STEMI), the most serious type of heart attack caused by a blockage of blood flow to the heart. National guidelines recommend that balloon angioplasty be performed within 90 minutes or less of arrival to the hospital.
This is the first time the hospital has achieved the gold designation; Huntington Hospital received the silver award last year.
“This achievement was made possible through Huntington Hospital’s partnership between its emergency department and cardiac catheterization laboratory teams, as well as our strong relationship with our community first responders,” said Lawrence Ong, MD, vice president of cardiology for Northwell Health’s Eastern region and chairman of cardiology at Huntington Hospital. The hospital has two cardiac catheterization laboratories as well as two electrophysiology areas
Treatment done this quickly has been made possible in part through the hospital’s use of the LifeNet system, which allows first responders to securely send important health information Electrocardiograms (ECG) to Huntington Hospital’s emergency cardiac team so they can mobilize to help the incoming patient.
For more information about Huntington Hospital’s cardiac services, call 631-351-2000.
At the St. Charles Give Veterans a Smile Day, veteran Kevin Magrane is treated by Michelle Wah, DDS; and Renee Calasciabetta, dental assistant.
Catholic Health Service’s (CHS) St. Charles Hospital Stephen B. Gold Dental Clinic in Port Jefferson recently hosted its 5th annual Give Veterans a Smile Day. The event provides men and women who have served our country in the armed forces with quality dental care free of charge.
This year’s event was dedicated to Mark Cherches, DDS, who passed away on September 18th. A military veteran, Dr. Cherches served as director of the St. Charles Dental Residency Program for 40 years and was instrumental in founding Give Veterans a Smile Day.
“It is humbling and very uplifting to help these men and women who have done so much to protect our freedom,” said St. Charles Department of Dentistry Director Keri Logan, DMD. “Many of our military veterans no longer have dental insurance. A veteran must be 100% service-disabled to qualify for dental care from the Veterans Administration.”
This year’s November 4th event provided service members numerous much-needed dental procedures, including exams, oral cancer screenings, cleanings, extractions and fillings. Also, free flu shots were provided.
Beginning in 2021, the Give Veterans a Smile Day will be held twice a year thanks to a grant from the Mother Cabrini Health Foundation.
For information about the Stephen B. Gold Dental Clinic, please call (631) 474-6332.
Statins may be overprescribed for the primary prevention of cardiovascular disease. Stock photo
Do primary prevention benefits outweigh the risks?
By David Dunaief, M.D.
Dr. David Dunaief
Statins were first approved in the U.S. over 30 years ago. Today, they are one of the most commonly prescribed medications in the United States. Yet, many in the medical community still disagree about who should be taking a statin and for what purpose; some believe that more patients should be on this class of drugs, while others think it is overprescribed. This is one of the most polarizing issues in medicine — probably rightly so.
The biggest debate is over primary prevention with statins. Primary prevention is treating people with high cholesterol and/or inflammation who may be at risk for a cardiovascular event, such as a stroke or heart attack. Currently, recommendations of the American College of Cardiology and the American Heart Association do not align with those of the U.S. Preventive Services Task Force, which is currently reviewing its own recommendations because of data updates.
Most physicians agree that statins have their place in secondary prevention — treating patients who have had a stroke or heart attack already or who have coronary artery disease.
We will examine benefits and risks for the patient population that could take statins for primary prevention. On one side are those who point to statins’ benefits: reduced cancer risk, improved quality of life and lowered glaucoma risk. On the other, we have those who note statins’ side effects: increased diabetes risk, fatigue and cataracts, to name a few. Let’s look at some of the evidence.
Effect on cancer
A study published in The New England Journal of Medicine involved 300,000 Danish participants and investigated 13 cancers. It showed that statin users may have a 15 percent decreased risk of death from cancer (1). As you can imagine, this news was greeted with excitement.
However, there were major limitations with the study. First, researchers did not control for smoking, which we know is a large contributor to cancer. Second, it was unknown which of the statin-using population might have received conventional cancer treatments, such as radiation and chemotherapy. Third, the dose of statins did not correlate to risk reduction. In fact, those who took 1 to 75 percent of prescribed statin levels showed more benefit in terms of cancer mortality risk than those who took more. We need a better-designed trial to determine whether there really is an effect.
Another study, a meta-analysis of 13 observational studies, showed that statins may play a role in reducing the risk of esophageal cancer. This is important, since esophageal cancer, especially adenocarcinoma that develops from Barrett’s esophagus, is on the rise. The results showed a 28 percent risk reduction in this type of cancer. The authors of the study surmise that statins may have a protective effect (2).
Although there is an association, these results need to be confirmed with randomized controlled trials. Aspirin has about the same 30 percent reduction in colorectal cancer, yet is not recommended solely for this use because of side effects.
Eye diseases: mixed results
In two common eye diseases, glaucoma and cataracts, statins have vastly different results. In one study, statins were shown to decrease the risk of glaucoma by five percent over one year and nine percent over two years (3). It is encouraging that the longer the duration of statin use, the greater the positive effect on preventing glaucoma.
Statins also help to slow glaucoma progression in patients suspected of having early-stage disease at about the same rate. This was a retrospective study analyzing statin use with patients at risk for open-angle glaucoma. We need prospective (forward-looking) studies. With cataracts, it is a completely different story. Statins increase the risk of cataracts by over 50 percent, as shown in the Waterloo Eye Study (4). Statins exacerbate the risk of cataracts in an already high-risk group, diabetes patients.
Quality of life and longevity:a mixed bag
In a meta-analysis involving 11 randomized controlled trials, statins did not reduce the risk of all-cause mortality in moderate to high-risk primary prevention participants (5). This study analysis involved over 65,000 participants with high cholesterol and at significant risk for heart disease.
However, in this same study, participants at high risk of coronary heart disease saw a substantial improvement in their quality of life with statins. In other words, the risk of a nonfatal heart attack was reduced by more than half and nonfatal strokes by almost half, avoiding the potentially disabling effects of these events.
Fatigue effect
Some of my patients who are on statins ask if statins can cause fatigue. A randomized controlled trial published in the Archives of Internal Medicine reinforces the idea that statins increase the possibility of fatigue (6).
Women, especially, complained of lower energy levels, both overall and on exertion, when they were blindly assigned to a statin-taking group. The trial had three groups: two that took statins, simvastatin 20 mg and pravastatin 40 mg; and a placebo group. The participants were at least 20 years old and had LDL (bad) cholesterol of 115 to 190 mg/dl, with less than 100 mg/dl considered ideal.
In conclusion, some individuals who are at high risk for cardiovascular disease may need a statin, but with the evidence presented, it is more likely that statins are overprescribed in primary prevention. Evidence of the best results points to lifestyle modification, with or without statins, and all patients with elevated LDL (bad) cholesterol should make changes that include a nutrient-dense diet and a reduction in fat intake, as well as exercise.
References:
(1) N Engl J Med 2012;367:1792-1802. (2) Clin Gastroenterol Hepatol. 2013 Jun; 11(6):620–629. (3) Ophthalmology 2012;119(10):2074-2081. (4) Optom Vis Sci 2012;89:1165-1171. (5) Arch Intern Med 2010;170(12):1024-1031. (6) Arch Intern Med 2012;172(15):1180-1182.
Dr. David Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, visit www.medicalcompassmd.com.
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