Wednesday, July 31, 2019
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Keep using sunscreen while FDA updates recommendations on safety of sunscreen ingredients
Media coverage of a recent study has left many people concerned about the safety of sunscreen. But while further testing appears to be warranted, we know for certain that sunscreen protects against skin cancer.
Let’s take a closer look at the JAMA study, evolving FDA recommendations on sunscreen ingredients, and how you and your family can safely protect yourself from the sun’s rays.
What did the study look at?
First, some background. The FDA recently announced that it will be updating its recommendations on the safety of sunscreen ingredients later this year. In general terms, they are trying to answer two questions:
- To what extent are the chemicals in sunscreen absorbed into the body?
- What are the health effects of these chemicals being absorbed into the body?
In the JAMA study, FDA researchers asked 24 healthy individuals to apply sunscreen four times a day for four days to large areas of their body. The participants were randomly assigned to apply a sunscreen spray, cream, or lotion. All of the sunscreens contained some combination of four active ingredients: avobenzone, oxybenzone, octocrylene, and ecamsule. Thirty blood samples were collected from the participants over seven days.
What did the study find, and what do the results mean?
The researchers found systemic concentrations of more than 0.5 nanograms per milliliter (ng/ml) of all four active ingredients in the blood of these volunteers.
These findings, while interesting, should be considered in the context of several limitations. This study is called an exploratory maximal usage trial (MUsT), because the sunscreen products were applied according to the maximum limit of the products’ directions for use, which likely far exceeds use by the average consumer.
Furthermore, while the FDA recommends that active ingredients in sunscreen that exceed 0.5 ng/ml should undergo toxicology testing to check for harmful health effects, this number is somewhat arbitrary, as it is not known what the significance of this blood level means. The FDA acknowledges that without further testing, we do not know what degree of absorption should be considered safe.
What is the FDA saying about sunscreen?
Thus far, titanium dioxide and zinc oxide are two sunscreen ingredients that the FDA deems “generally recognized as safe and effective” (GRASE). These ingredients are not absorbed into the body.
In order to be determined GRASE, a drug must have gone through adequate clinical testing to establish its safety and efficacy, and medical experts must agree, based on those studies, that the product is safe based on the intended, recommended usage. Two other active sunscreen ingredients, PABA and tolamine salicylate, are considered non-GRASE, and they are not legally available in the US.
The FDA is asking for more safety data on an additional 12 active sunscreen ingredients in order to determine whether they can be classified as GRASE. Any sunscreen ingredients that do not receive a GRASE designation in the FDA’s final report, due to be delivered in November 2019, will need to go through a New Drug Application (NDA) process. New products that contain GRASE ingredients do not need to go through the NDA process.
Should I keep using sunscreen?
Absolutely. Exposure to ultraviolet (UV) rays from the sun is a major risk factor for skin cancer, which is the most common type of cancer in the US. Sunscreen use has been shown to protect against UV-induced skin cancers — as well as sunburns and signs of aging.
The FDA has not asked the public to stop using sunscreens that contain avobenzone, oxybenzone, octocrylene, or ecamsule. That’s because while the JAMA study concluded these ingredients were absorbed by the body when applied at high concentrations, we do not know whether this affects a person’s health.
Furthermore, there have not been any reports of serious side effects from sunscreen products related to systemic absorption. In fact, the FDA has announced on its website that “given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreen and other sun protective measures as this important rulemaking effort moves forward.”
What should I do to protect my skin until the FDA releases its new recommendations?
Continue to follow these dermatologist-recommended practices:
- Avoid going into direct sunlight or seek shade between 10 am and 2 pm, which is when UV radiation is the strongest.
- Apply sunscreen to all exposed areas, using a broad-spectrum sunscreen that is SPF 30 or higher.
- Sun protective clothing, including long-sleeve shirts, long pants, hats, and sunglasses, can be a wonderful option for sun protection, especially for young children. Look for clothing that has an ultraviolet protection factor (UPF) rating.
For more information on sunscreens and safety, visit this website by the American Academy of Dermatology.
Follow me on Twitter @KristinaLiuMD
The post Keep using sunscreen while FDA updates recommendations on safety of sunscreen ingredients appeared first on Harvard Health Blog.
UK HealthCare again named best Ky. hospital in U.S. News & World Report rankings; Baptist Health has three of six on list
Kentucky Health News
Six Kentucky hospitals have been named among the nation's "Best Regional Hospitals" in the annual rankings by U.S. News & World Report magazine.
They are, in order: the University of Kentucky hospital, St. Elizabeth Healthcare Edgewood-Covington Hospitals, and in a tie for third, Baptist Health Lexington, Baptist Health Louisville, Norton Hospital in Louisville and Baptist Health Paducah.
To make the list, a hospital must offer a full range of services and either be ranked nationally in one of the 12 measured specialties or have three or more high-performance specialty rankings or three or more high performance procedures and conditions rankings.
UK HealthCare, for the fourth consecutive year, claimed the No. 1 ranking with its Albert B. Chandler Hospital. The hospital also ranked in the top 50 hospitals nationally for cancer for the third year in a row, moving to its highest ranking yet in this category, 33rd. The hospital's Markey Cancer Center is the state's only National Cancer Institute center, one of 71 in the nation.
"The criteria for a hospital to be listed in the top 50 for cancer care is rigorous and competitive," Dr. Mark Evers, director of the center, said in a news release. "This ranking, along with our status as an NCI-designated cancer center, is evidence of how we are making an impact in cancer care across Kentucky and beyond."
Among specialties, UK ranked as high performing in geriatrics, nephrology (kidneys) and orthopedics.
The rankings, now in their 30th year, compared more than 4,500 medical centers across the country in 25 specialties, procedures and conditions. Kentucky has more than 120 hospitals.
Baptist Health had three of the state's top six hospitals, with Baptist Health Paducah gaining its first ever rank in the Best Hospitals survey, according to a Baptist Health news release.
“Our physicians, nurses and staff are centered on providing high quality patient care every day,” Gerard Colman, Baptist Health CEO, said in the release. “U.S. News & World Report rankings underscore that excellence, and confirm that we’re living out our mission of leading in clinical excellence, compassionate care and growth to meet the healthcare needs of our communities.”
The report also recognizes hospitals that are "high performing" for nine common adult procedures and conditions, including repair of abdominal aortic aneurysms, aortic valve surgery, chronic obstructive pulmonary disease, colon cancer surgery, heart bypass surgery, heart failure, hip replacement, knee replacement and lung cancer surgery.
UK Healthcare ranked high performing in all of the categories except abdominal aortic aneurysm repair, for which it received an average rating.
St. Elizabeth Healthcare ranked high-performing in one specialty, urology, and all but one of the procedures and conditions; it received an average rating for heart bypass surgery.
Baptist Health Lexington ranked high-performing for all the procedures and conditions except aortic valve surgery and knee replacement, for which it was rated average.
Baptist Health Louisville ranked high-performing for all the procedures and conditions except hip replacement and lung cancer surgery, for which it got an average rating.
Norton Hospital ranked high-performing for five of the procedures and conditions (COPD, colon cancer surgery, heart failure, hip replacement and knee replacement). It got an average rating on the other four.
Baptist Health Paducah ranked high-performing for aortic valve surgery, COPD and heart failure and was rated average rating on the other six.
Louisville's Jewish Hospital, which included evaluations of Sts. Mary and Elizabeth Hospital, dropped off of this year's U.S. News & World Report Best Regional Hospital list, having only ranked high-performing in two of the procedures and conditions categories, including COPD and heart failure. It received average marks for the rest.
Jewish Hospital recently put its heart transplant program on hold, and the future of the hospital remains uncertain since the University of Louisville announced in June that it would not purchase it.
The report offers an overview of 123 Kentucky hospitals with a breakdown of each of the measured categories, as relevant to the services the hospital provides. Click here for more information on how the magazine ranks the hospitals, including details on this year's methodology changes.
Nationally, the Mayo Clinic in Rochester, Minn. claimed the No. 1 spot again on the Best Hospitals Honor Roll. Massachusetts General Hospital ranked No. 2, followed by Johns Hopkins Hospital in Baltimore at No. 3, according to the magazine's news release.
Tuesday, July 30, 2019
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Should you see a chiropractor for low back pain?
If you’ve ever seen a doctor for back pain, you’re not alone. An estimated 85% of people experience back pain severe enough to see a doctor for at some point in their life. Yet despite how common it is, the precise cause of pain is often unclear. And a single, best treatment for most low back pain is unknown. For these reasons, doctors’ recommendations tend to vary. “Standard care” includes a balance of rest, stretching and exercise, heat, pain relievers, and time. Some doctors also suggest trying chiropractic care. The good news is that no matter what treatment is recommended, most people with a recent onset of back pain are better within a few weeks — often within a few days.
What’s the role of chiropractic care?
Some doctors refer back pain sufferers to a physical therapist right away. But many people with back pain see acupuncturists, massage therapists, or a chiropractor on their own. Experts disagree about the role of chiropractic care, and there are not many high-quality studies to consult about this approach. As a result, there are a number of questions regarding the role of chiropractic care: Should it be a routine part of initial care? Should it be reserved for people who don’t improve with other treatments? Are some people more likely to improve with chiropractic care than others?
The answers to these questions go beyond any academic debate about how good chiropractic care is. Estimates suggest that low back pain costs up to $200 billion a year in the US (including costs of care and missed work), and it’s a leading cause of disability worldwide. With the backdrop of the opioid crisis, we badly need an effective, safe, and non-opioid alternative to treat low back pain.
A recent study on chiropractic care for low back pain
A 2018 study published in JAMA Network Open is among the latest to weigh in on the pros and cons of chiropractic care for treating low back pain. Researchers enrolled 750 active-duty military personnel who complained of back pain. Half were randomly assigned to receive usual care (including medications, self-care, and physical therapy) while the other half received usual care plus up to 12 chiropractic treatments.
After six weeks of treatment, those assigned to receive chiropractic care:
- reported less pain intensity
- experienced less disability and more improvement in function
- reported higher satisfaction with their treatment
- needed less pain medicine.
While no serious side effects were reported, about 10% of those receiving chiropractic care described adverse effects (mostly stiffness in the joints or muscles). Five percent of those receiving usual care had similar complaints.
All studies have limitations
And this one is no exception. While this study suggests that chiropractic care may be helpful for low back pain, some aspects of the study make it hard to be sure. For example:
- It only lasted six weeks. As mentioned, most new-onset back pain is better by then regardless of treatment. For those with more long-lasting back pain, we’ll need more than a six-week study.
- The differences in improvement between those receiving chiropractic and usual care were small. It’s not clear how noticeable such a difference would be, or whether the cost of chiropractic care would be worth that small difference.
- The study included a mix of people with new and longer-standing low back pain and a mix of types of pain (including pain due to a pinched nerve, muscle spasm, or other reasons). If this study had included only people with muscle spasm, or only people who were obese (rather than military recruits), the results might differ. So, it’s hard to generalize these results to everyone with back pain.
- Most of the study subjects were young (average age 31) and male (77%). All were generally healthy and fit enough to pass military fitness testing.
- Study subjects knew which treatment they were receiving. This creates potential for a placebo effect. Also, the added time and attention (rather than the spinal manipulation) might have contributed to the response. Then again, these factors may not matter to a person who just wants relief.
- This study only included people who were willing to receive chiropractic care.
Even within the two groups, the care varied — that is, not everyone in the usual care group received the same treatment, and this can also be said for the chiropractic group.
If any of these factors had been different, the results might have been different. For example, it’s possible that if an older population of people with chronic low back pain had been studied, “usual care” might have been the better treatment.
Bottom line
This new study lends support for chiropractic care to treat low back pain. But it’s important to recognize the limitations of this trial, and keep in mind that treatment side effects were more common among those receiving chiropractic care. In addition, chiropractic treatments aren’t free (although, fortunately, insurance coverage for chiropractic care is becoming more common).
This won’t be — and shouldn’t be — the last study of chiropractic care for low back pain. But until we know more, I’ll continue to offer it as one of many treatment options.
The post Should you see a chiropractor for low back pain? appeared first on Harvard Health Blog.
Monday, July 29, 2019
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New FDA-approved weight loss device shows promise
Obesity is a disease that currently affects our population in epidemic proportions, and which has a profound effect on health and quality of life. As a physician dedicated to the prevention and treatment of the medical complications of excess weight, I frequently see patients whose efforts at restricting calories and increasing physical activity are not resulting in sustained weight loss.
When that’s the case, particularly if the excess weight is causing health issues, we can consider adding other treatment tools, which include weight loss medications, or weight loss surgeries. And while these options have increased dramatically over the last one to two decades, we still desperately need more treatments, as neither medications nor surgery are accessible or appropriate for every individual affected by obesity.
What is Plenity?
Gelesis100 (Plenity), just approved by the Food and Drug Administration in April and expected to come on the market later this year, is an exciting recent innovation in weight management. Although Plenity comes in capsule form, it is actually a weight loss device, not a medication. The capsules are filled with hydrogel particles. When taken with a full glass of water before meals, the particles expand in the stomach and take up space, leading to the sensation of fullness. The gel particles eventually move through the intestinal tract, and are broken down by enzymes and excreted.
In the pivotal randomized, double-blind, placebo-controlled clinical trial about 60% of those who followed a diet and exercise plan plus took Plenity lost 5% or more of their initial weight. And about 25% of those who took it were high responders, losing 10% or more of initial weight. Average weight loss was modest: -6.4% for the Plenity group vs -4.4% for the control group. (Of note, the desired endpoint of achieving at least 3% more weight loss in the Plenity group compared to the control group was not met.)
Who might benefit from Plenity?
Given the modest weight loss effects, Plenity will not be the cure to the obesity epidemic. And for people with significant weight to lose, it may not help enough.
Even so, I am enthusiastic about the approval of Plenity as the first treatment of its kind for overweight and obesity, because of how it will fit into the landscape of weight reduction treatments. Plenity is approved for use not only in those with obesity (defined as a body mass index [BMI] above 30) but also in people who are overweight (starting at a BMI of 25). This means that a broader population might be eligible to use Plenity compared to weight loss medications, which are approved for people with a BMI above 30, or a BMI above 27 with certain medical conditions, such as type 2 diabetes.
Access for those who have overweight, but who would not be eligible for pharmacologic (or surgical) treatments, could be incredibly impactful. Not only is close to 40% of the world population in the overweight range, but weight loss at lower BMI can help prevent future weight-related health problems.
What else do I need to know about this new weight-loss device?
There were few safety concerns in the clinical trial of Plenity; in fact, no treatment-related serious adverse events occurred. In addition, Plenity is not absorbed into the body at all. As a result, there is little reason to worry about pharmacologic side effects, or interactions with other medications, both of which frequently limit people’s ability to use weight-loss drugs.
This treatment approach also holds promise for future incremental innovations. For example, the in-the-pipeline Gelesis200 (not to be confused by Harry Potter fans with the Nimbus 2000), is based on Gelesis100 and is currently being studied for possible effects on coexisting obesity and diabetes. And as further research is conducted, we may gain the ability to predict who will be a high responder, and select those individuals for treatment.
The devil is always in the details, and we still don’t know how much these capsules are going to cost. Those of us who work to help people lose weight — and those of us who need to lose it — stand to be quite disappointed if it’s priced as high as most weight loss medications, or is not covered by insurance.
It is exciting that as we continue to understand more about obesity, we have more medical strategies to help people lose weight. I am cautiously optimistic that Plenity will represent a safe and effective option for a subset of people with overweight and obesity.
The post New FDA-approved weight loss device shows promise appeared first on Harvard Health Blog.
Sunday, July 28, 2019
Scores of reported cases of Rocky Mountain spotted fever in Lincoln Trail area; awaiting state health department confirmation
Rocky Mountain spotted fever, the main tick-borne disease in Kentucky, has affected scores of people in the area served by the Elizabethtown-based Lincoln Trail District Health Department.
The six-county department "has investigated a total 79 cases of Rocky Mountain spotted fever for June in the district, which comprises Hardin, Meade, LaRue, Nelson, Washington and Marion counties," Mary Alford reports for The News-Enterprise in Elizabethtown.
In Grayson County, which is in the Lincoln Trail Area Development District but has a separate health department, 26 cases were reported from July 7 to 17. All the numbers are subject to confirmation by the Kentucky Department for Public Health. In a typical year, the entire state has 10 to 30 cases, Grayson Brown, director of the University of Kentucky Public Health Entomology Laboratory, told Kentucky Health News as the summer tick season began.
Dog ticks (middle) are the usual carriers of Rocky Mountain spotted fever. |
How can you protect yourself from these diseases, which can be debilitating and in rare cases fatal? Use insect repellents, shower soon after being outdoors, and check for ticks daily, especially in hard-to-see places, Rebecca Morris writes for The Record in Grayson County, citing material from the federal Centers for Disease Control and Prevention web page about ticks.
CDC recommends "a full body check upon return from potentially tick-infested areas," Alford writes. "Ticks most commonly attach around the ears, inside the belly button, behind the knees, between the legs, around the waist and especially in and around the hair. To remove a tick, people should use tweezers to grab the tick close to the skin and gently pull on the arachnid with steady pressure, and wash hands and the bite site with soap and water after the tick is removed. Also, apply an antiseptic to the bite."
Other tips, from UK's Brown:
- Check your pets.
- Keep grass and shrubs trimmed, and clear overgrown vegetation in your yard.
- Don't walk through uncut fields, brush and overgrown areas.
- Walk in the center of hiking trails.
- Wear light-colored clothes, which make it easier to spot ticks.
- Wear long pants tucked into boots or socks, and tuck your shirt into your pants.
- Place a band of duct tape, sticky side out, around your lower legs to trap ticks.
- Use tick repellent that has DEET or picaridin, or use permethrin-based clothing sprays.
"After five days without medical treatment, patients can have altered mental states, lapse into a coma, develop respiratory problems or even have organ failure," Morris writes, citing the CDC. The disease "can lead to death if patients aren't treated early."
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Health departments and their employees making tough choices now that the General Assembly has passed Bevin's pension bill
The law written and signed by Gov. Matt Bevin freezes the pension costs of health departments for another year, at 49 percent of payroll, avoiding an increase to 83 percent, which would have forced layoffs and program cuts, and could have put some of them out of business.
But now the health departments must choose whether to stay in the Kentucky Retirement System "at full cost, leave the retirement system by paying a lump sum equal to future projected benefits payments, or buy their way out in installment payments over 30 years," writes David Zoeller of The Paducah Sun.
Zoeller notes that the Marshall County Health Department "has already been making tough decisions," such as ending its school-nurse program and cutting its staff by almost 30 percent.
John Cheves of the Lexington Herald-Leader notes, "Public employers that quit KRS will be encouraged through financial incentives to freeze their employees’ pensions so they accrue no further benefits. Instead of a pension, employees will be transferred into a riskier defined-contribution retirement plan, such as a 401(k), with a balance that rises and falls with the stock market, and that retirees can outlive if their money runs dry. . . . Some could lose hundreds of thousands of dollars in anticipated retirement benefits if their pensions are frozen."
Cheves's object example is the Garrard County Health Department, which has seven employees, some of whom are less than 10 years from retirement. "Under the state pension formula, the final decade on the job is crucial to maximizing their monthly retirement checks," he notes, and gives a specific example:
"Cathy Stapleton, a nurse at the health department, is 55 with plans to retire at 62. She doesn’t want her pension to be frozen and replaced with a 401(k) account that would have seven years — not the usual 30 to 40 — to build wealth through compound interest. One ill-timed market crash could sink her." She told Cheves, "It means a lot when you come into a pension. It means you have a retirement where you can count on having that income every month." Getting a new 401(k) plan at age 55 "would be a lot different."
Department Director J Smith told Cheves he will recommend to the Garrard County Board of Health that it stick with KRS and pay the 83 percent. "Telling middle-aged people who devoted their lives to public service that they’re suddenly going to risk financial insecurity in their senior years is not a viable choice, he said," Cheves reports, quoting him directly: “We’re not going to opt out. If we opt out, to me, we’re screwing our employees here. Some of my people have got just a few years left. We expect to get what we were promised. We were promised a pension.”
The department has already eliminated family-planning services, cut health education, "laid off its emergency-preparedness coordinator and a front desk clerk, and officially eliminated a third position, Smith’s old job, which he still does in addition to being director," Cheves reports. "That means he splits his time between inspecting schools, businesses, septic tanks and the like for safety and cleanliness, and managing the department."
“I’ll admit, our response time is slower now because of it,” Smith told Cheves. “When people used to call in for a site evaluation, we usually could get out there the same day. Now it might take us a week. It’s just — I’m sorry, we don’t have the people we used to. . . . I told our Board of Health that if we want to keep the services we have left, we’re going to have to have a tax increase.”
Kentucky River District Health Dept. area |
Skin-cancer rates have spiked 800% among young women; experts advise limiting exposure to sun and tanning beds
The research, presented at the summer meeting of the American Academy of Dermatology, found that between 1970 and 2009, rates of melanoma, the deadliest form of skin cancer, increased 800 percent among women 18 to 39, an AAD news release said.
During a similar time frame, the researchers also found that basal-cell and squamous-cell carcinoma rates also increased, 145% and 263%, respectively.
“Because there’s a delay between UV exposure and when skin cancer appears, most women don’t think it will happen to them,” Dr. M. Laurin Council, a dermatologist and associate professor at Washington University in St. Louis, said in the release. “This data reveals the disproportionate rise in the number of skin cancers in women and the need for further education regarding UV exposure.”
Indoor tanning by Caucasian girls and young women "is of particular focus," says the release, because it is estimated that indoor tanning may cause more than 400,000 cases of skin cancer in the U.S. each year.
"One indoor tanning session can increase a user's lifetime risk of developing melanoma by 20%, squamous cell carcinoma by 67% and basal-cell carcinoma by 29% . . . and this risk increases with each use," says the release.
Council says limiting exposure to UV rays from the sun or other sources like tanning beds is the best way to decrease your risk for skin cancer. She adds that it is especially important to avoid sun exposure between the hours of 10 a.m. and 2 p.m. because that's when the sun's rays are the strongest.
The Centers for Disease Control and Prevention adds that the sun's UV rays can damage your skin in as little as 15 minutes and notes that a tan does not indicate good health, but instead is the skin's response to injury, because skin cells signal that they have been hurt by UV rays by producing more pigment called melanin.
"Every time you tan, you increase your risk of getting skin cancer," says the CDC.
Other suggestions to protect yourself from the sun include wearing protective clothing including lightweight, long-sleeved shirts and pants, a wide-brimmed hat and sunglasses when out in the sun, as well as using a broad-spectrum, water-resistant sunscreen with an SPF of 15 or higher (Council says the SPF should be 30), and apply every two hours, as well as after swimming or sweating
Council also calls on parents to teach their children about the dangers of sun exposure and tanning beds, and their relationship to skin cancer.
In Kentucky , melanoma of the skin, or skin cancer, is one of the top 10 cancers by rates of new cases, at 28.7 cases per 100,000 people.
UK gets $11 million grant to decrease cervical cancer in Eastern Ky. with focus on risks: smoking, HPV and low rates of screening
The research will address three of the risk factors that contribute to these high rates -- smoking, the human papillomavirus (HPV) and low rates of cervical-cancer screenings among women in the region, according to the news release.
The first project in the program will work to reduce smoking among women in rural communities through various interventions, including strategies to help women who are not quite ready to quit, the lead investigator of this project told Alex Acquisto of the Lexington Herald-Leader.
"Instead of ignoring the smokers who are not ready to quit today, we're going to work with them anyway," said Jessica Burris, an assistant professor of psychology and a member of UK's Markey Cancer Prevention Control Program.
Eastern Kentucky has some of the highest rates of smoking in the nation, which contributes to its likewise high rates of cervical cancer. Smoking not only causes cancer almost anywhere in the body, it can also block your body from fighting it once you have it, says the federal Centers for Disease Control and Prevention. And women who smoke are about twice as likely as non-smokers to get cervical cancer, according to the American Cancer Society.
Mark Dignan, professor in the UK College of Medicine and co-leader of the Markey Cancer Prevention and Control Program, will lead two projects that focus on the human papillomavirus, or HPV, which the CDC attributes to 90 percent of all cervical cancers.
"We really shouldn't have cervical cancer," Dignan told Acquisto. "We know what causes it, we can detect it, and we can treat it." It is the only cancer for which there is a vaccine, but Kentucky's children are among the least vaccinated for HPV, one of the most common sexually transmitted diseases
The grant will fund a project to improve HPV vaccination rates among people between 11 and 26. The other will mail HPV self-testing kits to women in the region who are not being screened for cervical cancer or are "underscreened."
In addition to cervical cancer, HPV can also cause cancers in the vagina, vulva, penis, anus, rectum and the back of the tongue and throat. Among these cancers caused by HPV, more than 90% could be prevented by the vaccine, according to the CDC.
Burris and Dignan told Acquisto that they expect around 70,000 Kentuckians to be impacted by their project, which is scheduled to start in a couple of months.
The project, funded by the National Cancer Institute, involves a collaboration by the Markey center with Ohio State University, the University of Virginia and West Virginia University. It will involve 10 health systems in Appalachia, including two in Kentucky: Big Sandy Health Care, which operates seven clinics in Eastern Kentucky, and Juniper Health, which has locations in Wolfe, Lee, Breathitt and Morgan counties.
Saturday, July 27, 2019
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Friday, July 26, 2019
Deepest study yet finds only 36% of those who'd be affected by Ky.'s proposed Medicaid work rules aren't meeting them already
Kentucky Health News
Gov. Matt Bevin says "hundreds of thousands" of able-bodied adult Kentuckians on Medicaid should be working but choose not to. But when his new Medicaid "community engagement" rules were set to kick in last July, only about 48,000 people on the program were short of meeting the requirements, according to a study of Medicaid records and a random-sample survey of people on the program.
Bevin made his assertion at a July 12 Kentucky Chamber of Commerce meeting in Louisville while promoting his new Medicaid plan, which, among other things, requires "able-bodied" adults on Medicaid who are not primary caretakers to work, attend school, take job training, search for a job or volunteer 80 hours a month, if they don't qualify for an exemption or are in drug treatment.
The plan, called Kentucky HEALTH, for Helping to Engage and Achieve Long Term Health, was set to start July 1, 2018. Two days before that, and again on April 1, it was blocked by U.S. District Judge James Boasberg of Washington, D.C. He ruled that federal officials failed to show how the requirements would serve the objective of the 1965 Medicaid Act, to provide people with medical coverage. He also struck down a similar plan in Arkansas. The administration of President Donald Trump has appealed the ruling.
The study was done by health researchers at the University of Pennsylvania, whom the state and the Centers for Medicare & Medicaid Services hired to evaluate Kentucky HEALTH if it takes effect. Kristi Putnam, deputy secretary of the state Cabinet for Health and Family Services, said the study was not commissioned by the cabinet, but was done under an agreement in the contract that allows the university to conduct its own research. The study was published in the Journal of the American Medical Association, meaning it underwent review by other experts before publication.
"I would disagree with that on a universal basis," she said. "I think you have to consider the whole picture of those who are not employed in Kentucky, and not just the ones who are not meeting [the requirements for] benefits programs that are at this point theoretical programs. I think you have to take it as a whole."
She added, "We still believe that there are those hundreds of thousands of people," but the way the study represents those individuals "is a little bit difficult to see."
The study findings
The researchers found that when the program was first set to roll out 13 months ago, 330,075 of the nearly 1.4 million Kentuckians on Medicaid would have been required to participate in Kentucky HEALTH in some way: work or other community engagement; reporting of engagement activities; paying income-based premiums; and earning credits to get free dental and vision care.
Of this group, 132,790, or nearly 40 percent, would have been required to meet the community engagement requirements (the only part of the program that the study evaluated). Most of the 132,790 people were already in compliance; 25,422 were excluded because they were medically frail, 57,981 were working the required 80 hours a month; 727 were volunteering that much; and 235 were doing a sufficient combination of work and volunteering.
That left 48,427 who were not meeting the proposed community-engagement requirements. That is 36% of those who would be required to meet those requirements, 15% of those who would be required to meet any of the other new requirements, and 3.5% of the total Medicaid population.
Chart shows how estimates were made. Data with blue backgrounds are population counts from claims data; in tan backgrounds are estimates from a survey of 9,396 Medicaid beneficiaries. |
"I recognize that the governor's statement was not [about] underemployment, but that is part of the group that we are trying to help through this," she said.
She said the number the cabinet typically uses to represent how many able-bodied individuals on Medicaid could be working is between 150,000 and 200,000, a number that she said varies because tens of thousands of people move in and out of the program each month.
When Bevin used the phrase "hundreds of thousands, his office told Kentucky Health News that the figure came from the Census Bureau's 2017 American Community Survey, a poll that estimated 443,723 Kentuckians "do not have a disability and are not in the labor force."
Dustin Pugel, a policy analyst at the liberal-leaning Kentucky Center for Economic Policy, pointed out that only 136,400 of the 443,723 people Bevin's office cited were eligible for Medicaid, had insurance, were not disabled and were not in the labor force. ""It becomes pretty clear that we are not talking about 443,000 sitting on their couches," he said.
He said the census poll shows that of the 136,400 Medicaid-eligibles who are not in the workforce, 57,800 had related children in their home; 24,600 were enrolled in school; 6,100 received retirement income; 19,000 received Medicare, which means they did not self-attest to a disability, but had a health condition that qualified them for Medicare coverage as a non-senio. He noted that the numbers are estimates rounded to the nearest hundred and have large error margins.
"The point is that there are far fewer than 443,000 Kentuckians covered by Medicaid who are not working, and of those who are covered by Medicaid but outside the labor force, many have good reason to be," he said. "To assume that all of them could or should turn around and 'go get a job' is wrong headed."
The study surveyed a random sample of 9,936 people who would be subject to the new requirements. That produced estimates of the well-being of the 48,427 who were not meeting the community-engagement requirements: 27% reported fair or poor physical health; 25% reported fair or poor mental health; 33% reported that a health condition limited their activities in the previous 30 days; 60% needed medical care in the last six months; 27% went to a hospital emergency department in the last six months; and 17.5% were working, but less than 80 hours a month.
Pugel and Jason Dunn, policy analyst with Kentucky Voices of Health, said the study, confirms what other studies have found, but is stronger because it used the survey and Medicaid claims during 2018.
"These studies all seem to come up with the same results," Dunn said. "People are either already working . . . and then the rest are providing care-taking for an ill or disabled relative or a child, or they are in school full time. There are just very few that meet that narrow population of not doing something, and we don't know why."
Pugel said, "We don't know what those folks situations are, we only know that they are not currently meeting the requirement as it is written."
Bevin and other advocates of the requirements have argued that free medical care discourages people from seeking work because they might lose their eligibility.
Dunn said the study "shows that the work reporting requirement is simply not necessary. That's the main point that we've been trying to get across, that requiring this level of activity for the sake of eligibility is not necessary. . . . It is ultimately going to harm people in the long run by denying them access to care."
The study also found that between 10% and 20% of those subject to the new rules may need to report hours through other means, like phone or mail, since they did not have access to the internet.
It found that the proportion of Medicaid enrollees that were required to meet the community engagement reporting requirement didn't vary by geographic area, despite large differences in economic opportunities across the Kentucky workforce areas.
The Green River region in Western Kentucky, which includes Owensboro, and Kentuckiana Works, which includes Louisville, stood out in the 10 local workforce areas because about 20% of those who would be required to report community engagement hours did not meet the proposed requirements. The rest of the state ranged from 12.6% to 15.6% for this measure.
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From Brexit to TRexit: Transperineal biopsies pose a challenge to the traditional transrectal biopsy method
By now most of us are familiar with Brexit, the UK’s pending divorce with the European Union. But in a play on that term, British doctors are also moving towards an exit they’ve dubbed “TRexit” from the most common sort of prostate biopsy: the transrectal ultrasound guided biopsy, or TRUS.
Men who test positive on the PSA cancer screening test will usually have a prostate biopsy that’s performed in either of two ways. With a TRUS, doctors guided by an ultrasound machine can sample the prostate using a biopsy needle inserted through the rectum. Alternatively, the biopsy needle can be inserted (also under ultrasound guidance) through the perineum, the patch of skin located between the anus and the scrotum. Since it’s traditionally been easier to perform, and less painful for the patient, the TRUS method is preferred globally, accounting for 99% of the estimated one million prostate biopsies performed every year in the United States.
But now, UK doctors want to abandon the TRUS for the transperineal method. Why? In short, because TRUS biopsies have been associated with a growing risk of hard-to-treat infections. According to Michael Gross, a researcher in the department of urology at Weill Cornell Medical College in New York, “up to 25% of all men carry antibiotic-resistant strains of E. coli bacteria at biopsy, and those rates are increasing across the country and across the world.”
During a TRUS procedure, E. coli and other fecal strains can glom onto the biopsy needle and enter the prostate. Up to 5% of TRUS-biopsied men develop sepsis, and many of them require costly hospitalizations. But since transperineal biopsies bypass the rectum and its associated bacteria altogether, the risks of infection are negligible by comparison.
Fewer threats from drug-resistant bacteria
At the 2019 annual meeting of the American Urological Association last May, a British team from Guy’s Hospital, London, reported results from a feasibility study with 678 men who were given a transperineal biopsy (58% of them under local anesthesia) for either suspected or diagnosed prostate cancer. The complication rates were low, and the incidence of sepsis requiring treatment among the men was 0.16%.
Doctors have mostly avoided transperineal biopsies because of the perceived need for general anesthesia, which is expensive and potentially risky for certain patients. Unlike the rectum, which has few nerve endings in regions close to the prostate, the perineum is highly innervated and sensitive to pain. But according to Gross, local nerve blockers can effectively limit pain from the transperineal biopsy, and recent published evidence shows some men actually prefer it to TRUS.
Studies have shown that, when combined with magnetic resonance imaging scans that focus on regions of the prostate that look suspicious for cancer, both sorts of biopsies detect clinically significant tumors with comparable accuracy.
Will doctors here take TRexit’s lead in abandoning TRUS for the transperineal approach? That remains to be seen, and depends on more access to training opportunities. “The doctor’s experience and comfort level with a transperineal biopsy is very important,” says Dr. David Crawford, a urologist at the University of California, San Diego. The American Urological Association gave its first course on transperineal office-based biopsy this year.
Gross and his colleagues say transperineal biopsies performed under local anesthesia in a doctor’s office offer a viable alternative as threats from antibiotic-resistant bacterial strains steadily increase. But in what’s becoming a more widespread practice, doctors who perform TRUS biopsies can also swab the rectum for bacteria days prior to conducting the procedure, and then give antibiotics targeted at the specific species they find. Dr. Jim Hu at Weill Cornell Medical College is currently putting together a multi-institutional study designed to compare infection rates between transperineal biopsies and TRUS biopsies preceded by a rectal swab.
“As with any procedure, the physician performing the biopsy must feel comfortable and familiar with it,” says Dr. Marc Garnick, Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor in chief of HarvardProstateKnowledge.org. “Future research is needed compare quality of the biopsies obtained by either approach, as well as their associated complication rates and overall patient satisfaction, before the transperineal biopsies procedure displaces the more traditional TRUS method here.”
The post From Brexit to TRexit: Transperineal biopsies pose a challenge to the traditional transrectal biopsy method appeared first on Harvard Health Blog.
HPV vaccine: A vaccine that works, and one all children should get
Human papillomavirus, or HPV, is the most common sexually transmitted infection. Most of the time, the body clears it without problems. But when it doesn’t, it can lead to cancer. HPV is the leading cause of cervical cancer, and it can also lead to cancers of the vagina, vulva, penis, anus, and mouth. Every year, there are more than 40,000 cases of cancer caused by HPV.
The HPV vaccine can prevent most of them.
Research shows the HPV vaccine is effective
A study published in the journal Pediatrics underlined just how effective the vaccine is. Researchers studied women ages 13 to 26 between 2006 and 2017, looking at their protection against different strains of HPV. They studied women because initially the vaccine was given only to women, so we have the longest data about its effects in women. What they found was really encouraging. Not only did the vaccine seem to protect against the strains covered by the vaccine, but women who got it were less likely to be infected by other strains, showing that the vaccine has cross-reactivity against other strains of HPV.
What was even more encouraging was that over the 10-year period, even women who didn’t get the vaccine became less likely to be infected with HPV. This is called herd immunity. By making the infection less common, those who are vaccinated help protect other people.
All of this is great news — and yet only about half of US teens are fully vaccinated against HPV. For comparison, 94% of US children have had both doses of MMR when they start kindergarten.
What makes some families hesitate about the HPV vaccine?
For some families, the fact that the vaccine prevents a sexually transmitted infection makes parents squeamish. While it’s understandable that parents of 11- and 12-year-olds (when vaccination usually begins, although it can be given as early as 9) might not think that their child needs to be protected against a sexually transmitted infection, vaccinating early makes sense. The vaccine works best if vaccination is complete well before they start having sex — and being realistic, not only is it hard to predict exactly when that will happen, but once teens get older it’s not always as easy to be sure they go to the doctor and get vaccinated. Doing it early ensures their protection.
And for parents who worry that giving the vaccine could somehow be perceived as permission to have sex, and might make teens more likely to do so, research shows that this doesn’t happen.
Parents also worry about the safety of the HPV vaccine. We have now had many years of experience with the vaccine, with many thousands of doses. The vast majority of side effects are mild, such as fever or muscle pain, and last only a day or two. Some teens feel faint after getting it, which is why it’s recommended that they sit or lie down for about 15 minutes afterward. While unexpected allergic reactions can always occur, lots of very careful research has not shown any serious side effects from the vaccine.
The bottom line
The bottom line: the HPV is a safe, effective vaccine that helps to prevent cancer. Whenever we are given a chance to prevent cancer, we should take it.
Follow me on Twitter@drClaire
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Thursday, July 25, 2019
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The DASH diet: A great way to eat foods that are healthy AND delicious
The Dietary Approaches to Stop Hypertension (DASH) diet is an eating plan based on eating plenty of fresh fruits and vegetables, and choosing lean proteins, low-fat dairy, beans, nuts, and vegetable oils, while limiting sweets and foods high in saturated fats.
A recent study published the American Journal of Preventive Medicine found that men and women younger than 75 who most closely followed the DASH diet had a significantly lower risk of heart failure compared to study participants who did not follow the DASH diet. Currently, about 5.7 million adults in the United States have heart failure, and about half of those who develop heart failure die within five years of diagnosis.
The DASH diet and heart health
This latest study adds to established research linking the DASH diet with heart health. For example, the original DASH trial, published in the New England Journal of Medicine in 1997, found that the DASH diet reduced blood pressure in adults with borderline high blood pressure (hypertension). Importantly, the DASH trial represented a broad spectrum of men and women, including racial and ethnic minorities from a variety of socioeconomic levels.
In a second study, researchers added a low-sodium modification to the DASH diet. In this trial, participants following a DASH diet were randomized to receive 3,000, 2,300, or 1,500 milligrams (mg) of sodium per day. The study found that the low-sodium (1,500 mg/day) DASH diet was as effective for lowering blood pressure as a first-line blood pressure-lowering medication. This is significant because, according to the American Heart Association, an estimated 103 million adults in the United States have high blood pressure, defined as a reading of 130/80 mm Hg or greater.
Why does the DASH diet work?
The DASH diet
- is low in saturated fat and dietary cholesterol
- is low in sodium (if following the low-sodium version)
- is rich in potassium, magnesium, calcium, protein, and fiber
- emphasizes fruits, vegetables, and low-fat dairy
- includes whole grains, fish, poultry, and nuts
- limits red meat, sweets, and sugary beverages.
These components seem to work synergistically to reduce risk factors for heart disease.
Getting started on the DASH diet
If you’d like to try the DASH diet, follow these guidelines, which are based on a 2,000 calorie per day diet.
Food group | Daily servings | Examples of one serving |
Whole grains | 6–8 | 1 slice bread; 1/2 cup cooked rice; pasta; 1 ounce dry cereal |
Vegetables | 4–5 | 1 cup raw, leafy vegetables; 1/2 cup cooked vegetable |
Fruit | 4–5 | 1 medium apple; 1 cup melon |
Low-fat/fat-free dairy | 2–3 | 1 cup milk or yogurt; 1 1/2 ounces cheese |
Lean meat, poultry, fish | 6 or less | 1 ounce cooked lean meat, fish, poultry; 1 egg |
Nuts, legumes, seeds | 4–5 per week | 1/3 cup nuts; 2 tablespoons peanut butter; 1/2 cup cooked legumes |
Fats and oils | 2–3 | 1 teaspoon healthy oil (olive); 2 tablespoons salad dressing |
Sweets | 5 or less per week | 1 tablespoon sugar; 1 cup soda; 1/2 cup sorbet |
Adapted from the National Heart, Lung, and Blood Institute, National Institutes of Health |
Here are some tips for incorporating the DASH diet throughout your day.
Fruits and vegetables
- Start loading up on fruits and vegetables with your first meal of the day. Try an egg white omelet, cooked in olive oil. Add spinach, mushrooms, and yellow and orange peppers. Or make a quick smoothie using strawberries, blueberries, greens, and low-fat yogurt or low-fat milk.
- Assemble a marvelous salad for lunch with fresh salad greens, your favorite fruits and veggies, a healthy protein like beans, tuna, chicken, or tofu, a sprinkling of nuts or seeds, some whole grains like farro or quinoa, and a drizzle of olive oil and lemon.
- Make a stir-fry for dinner. Start with a healthy oil (olive or peanut), add some garlic, and load up with onions, peppers, baby bok choy, broccoli, mushrooms, asparagus, and any other vegetables you may have. Frozen vegetables are fine too. Make a little space in the wok to cook some chicken, shrimp, or tofu. Don’t forget to add some spices for flavor!
Dairy and whole grains
- Try a whole-grain cold cereal with low-fat milk or old-fashioned oats prepared using milk.
- Use low-fat cottage cheese and add some fresh chives. Serve on a few whole-grain crackers.
- Make a whole-wheat pasta and add some low-fat feta or goat cheese. Include a few peas and cherry tomatoes. Top with some extra virgin olive oil or a little pesto.
Healthy fats
- For a healthy dressing, mix 2/3 cup extra virgin olive oil to 1/3 cup vinegar, add a teaspoon of Dijon mustard, a dash of salt, and some ground pepper.
- Use olive oil when preparing roasted, stir-fried, or grilled vegetables.
- Try avocado toast — a slice of whole-grain bread with 1/2 an avocado sliced thin. Squeeze some fresh lemon over, and top with a teaspoon of sesame seeds.
Nuts, legumes, and seeds
- Add some nuts to your oatmeal or plain yogurt.
- Add pumpkin or sunflower seeds to salads.
- Have a small package of nuts or seeds on hand as a late afternoon snack.
- Make a vegetarian chili with black or red beans, chopped onions, canned tomatoes, minced garlic, cumin, and chili powder. If you use canned beans, rinse and drain them or buy the low-sodium version.
Fish, poultry, or lean meat
- Use lean protein as a part of the meal, not as the focus or the only food on your plate.
- Add chicken, fish, and occasionally lean meat to soups and salads where vegetables, whole grains, herbs, and nuts can take center stage.
- Try fish or chicken kabobs on the grill with chunks of red onion, portobello mushrooms, and yellow, red, and green peppers.
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Opioids for acute pain: How much is too much?
Two recent articles have again highlighted how often opioid pain relievers — medications like oxycodone and hydrocodone — are excessively prescribed in the US for acute pain, sometimes for vulnerable populations and sometimes for conditions for which they are probably not even indicated.
The first paper, by authors at Boston Children’s Hospital, evaluated visits to the emergency department by adolescents and young adults (ages 13 to 22) over an 11-year period from a nationwide sample. About 15% of patients — roughly one in six — were prescribed an opioid, with high rates seen for ankle sprains, hand fractures, collarbone fractures, and particularly dental issues, for which an incredibly high 60% of patients in this age group received an opioid.
Speaking of dental issues, the second paper compared opioid prescribing by dentists in the US and England. In this study, the researchers looked at opioid prescriptions in 2016, and the numbers are shocking. In the US, 22% of prescriptions written by dentists were for opioids, compared with just 0.6% for British dentists, and US dentists prescribed about 35 opioids per 1,000 population, compared to just 0.5 opioid prescriptions per 1,000 population in England. Additionally, the opioid prescribed in England was a relatively weak codeine-like drug, whereas in the US the majority of prescriptions were for hydrocodone, a stronger opioid with greater abuse potential.
When does an opioid prescription make sense?
It is simply impossible that pain experienced by people in the US is that staggeringly different than in the UK. So why the discrepancy? While it is possible that pain is being undertreated in the UK and more adequately treated in the US, I don’t believe that to be the case. The difference is that, in the US, prescribers were reassured for years that opioids were a safe and effective way to treat pain. And yes, they are effective, but as evidenced by the vast increase in opioid-related overdose deaths seen in the country over the past decade, they are not safe.
On the other hand, medications like acetaminophen and ibuprofen — those over-the-counter pain medicines that you can get at any supermarket — actually work amazingly well for acute pain. As an example, a large survey study of over 2,000 patients who underwent a range of dental procedures discovered that the vast majority experienced adequate pain relief with over-the-counter or non-opioid prescribed pain medications. And similar studies are abundant. Another study looked at patients treated for low back pain in the emergency department and found no difference in pain after five days, whether the patient was treated with an anti-inflammatory medicine (naproxen) or if an opioid was added. It just didn’t make a difference, so why take the risk?
Yet another study evaluated variation within the US for treatment of ankle sprains. Over 30,000 patients were studied. On average, about a quarter of patients received an opioid prescription, but the state-level differences were astounding, ranging from under 3% in North Dakota to 40% in Arkansas! All for a condition that, in general, should get better with ice, elevation, and a brace.
Of course, there are times when the over-the-counter medications are not going to be sufficient to treat acute pain. In those situations, the goal should be to take the non-prescription medications first, and then add an opioid only when the pain is unbearable. Typically, this period of severe pain is in the first three days after a surgery or trauma. For example, colleagues in my department evaluated opioid consumption in the days after suffering an acute fracture. Most patients needed only about six pills of oxycodone.
The same trend is seen after surgery. A large study of six other studies found that between two-thirds and 90% of post-operative patients reported unused opioids after their surgery, and as many as 71% of the tablets went unused. We therefore subscribe to the recommendations of the Opioid Prescribing Engagement Network (OPEN) program in Michigan, which recommends relatively small opioid prescriptions after surgery, such as 10 pills after having your appendix removed or hernia repaired, and just five for procedures like a breast biopsy. Patients do fine, even with these smaller numbers of pills, and are at less risk of developing long-term opioid use.
What to be aware of for teenagers and young adults who get an opioid prescription
My general recommendation for opioid-naïve patients, regardless of age, is the following: if you have a simple problem, like a sprain or a dental procedure, or even back pain, do whatever you can to avoid an opioid. Ask your doctor about which over-the-counter pain treatments you can safely take and maximize those. For more severe pain, such as from fractures or after surgery, use the minimum number of opioids needed to tolerate the pain, then back off once the pain is bearable and continue with the non-prescription treatments.
For adolescents and young adults, extra caution is needed. The adolescent brain is developmentally predisposed to developing addiction, and therefore at high risk. Although opioid misuse among teens is decreasing, it still is a major problem. Among high school seniors, past-year misuse of pain medication was 3.4% in 2018, and about a third of high school seniors thought that these drugs are easily accessible. It is therefore paramount to protect adolescents from these medications. If prescribed, they should ideally be stored securely and dispensed by a parent or guardian following the appropriately prescribed schedule. Education about the medicine, and the dangers of being dependent on the medication, is essential. This is also a great time for parents to talk to their children about drug use in general.
What to do with leftover pills
When the acute pain from those first few days is gone, if there are leftover opioid pills, discard them safely. I cannot reiterate this enough. About two-thirds of adolescents who misused opioids got them from friends or family for free. There are lots of places to safely discard pills. In fact, the Drug Enforcement Administration offers a website that lists the closest bin locations. If one of those is not accessible, mix the medication with coffee grounds or dirt, seal it in a plastic bag, and dispose of it in the trash. Just be sure not to flush it down the toilet, as opioids and other drugs can contaminate the water supply.
The post Opioids for acute pain: How much is too much? appeared first on Harvard Health Blog.
Tuesday, July 23, 2019
Republican legislators propose taxing electronic cigarettes, as a health measure and a revenue measure
Foundation for a Healthy Kentucky President Ben Chandler shakes hands with Rep. Jerry Miller as Rep. Kim Moser and Health Comm. Jeff Howard look on. |