FDA Issues New Warning on Testosterone Therapy Medication

The Food and Drug Administration (FDA) announced on March 3rd that it will require pharmaceutical companies that produce testosterone replacement therapy (TRT) medication to include warning labels on their products regarding the potential risk for heart attack and stroke.

ABC affiliate KVUE News reports that the FDA is concerned that the popular and controversial treatment for low testosterone in men can increase the risk of heart attack, stroke, and other cardiovascular problems. Its warning comes after a 2014 study that suggests TRT doubled the risk of heart attack for men over 65, and tripled the risk for younger men with pre-existing heart conditions.

Not all in the medical field agree with the FDA’s assessment, however. Dr. Paul Pagley, a cardiologist at the Heart Hospital of Austin and Austin Heart, considers the FDA’s demand for a warning label to be dubious, as there are several other studies that come to the opposite conclusion — that TRT doesn’t increase risk at all.

“It’s a little bit of a controversial topic right now,” Pagley said. “There may be some increased risk of heart attack or other heart problems with testosterone supplementations. On the other side of the fence, testosterone has a lot of good effects for men with true low T.”

Patients with “low T” (as low testosterone, or hypogonadism, is commonly shortened to) are actually exempt from the FDA’s warning as TRT does improve such patients. However, the risk for cardiovascular illnesses increases for those who do not have low T, but who simply take it in an attempt to increase strength and stamina.

“To use testosterone, it should be a definite requirement,” Pagley said. “In other words, it’s truly for men with true low testosterone. It should not be used in a situation just to feel better or stronger.”

In addition, the Seattle Times reports that men taking cholesterol medicine such as pitavastatin (Livalo), atorvastatin (Lipitor), and simvastatin (Zocor) are also at risk of having the testosterone levels drop, so they are cautioned about taking TRT medicine.

Low testosterone can be tricky to diagnose. The male body’s testosterone levels naturally peak around 30 years of age and subsequently decreases by 1-2% every year. Some patients initially feel that their symptoms are mere signs of aging. Men who suspect they have low testosterone should seek out medical testing immediately.

Testosterone Replacement Therapy Not Linked With Cardiovascular Risks, Study Finds

The debate over the effectiveness and safety of testosterone replacement therapy (TRT) now has another study to contend with.

Hcplive.com reports that on March 7th, a team of researchers in the United States and the United Kingdom released a study on the potential link between TRT and cardiovascular illness. Presenting at the Endocrine Society’s 97th Annual Meeting and Expo (commonly referred to as EXPO 2015) in San Diego, California, the team found no definite link between cardiovascular conditions such as heart disease and stroke and the popular treatment for low testosterone.

The team openly admits that prior studies and literature reviews have lead to conflicting conclusions regarding the link. They add that their study is no different. The uncertainly, they feel, has been “heightened by recent retrospective analyses of observational data. Prior studies, including relatively small prospective clinical trials of hypogonadal men, have yielded conflicting results.”

Dr. Salim Janmohamed, head of the research team, and his colleagues reviewed data from two large, placebo-controlled clinical trials conducted in different countries that studied the effect of darapladib, an inhibitor used to treat atherosclerosis. The trials included adults of both genders with a history of either stable coronary heart disease or recent acute coronary syndrome. The subjects of the student underwent treatment for cardiovascular risk factors. Specially, the researchers focused on three major cardiovascular events, also called MACE: cardiovascular death, heat attacks, and strokes.

The team found that ultimately darapladib “did not significantly reduce the risk of CV events.” They studied the risk of MACE in men who underwent testosterone replacement therapy for both less than a year and more than a year, and compared them to men who did not undergo the therapy from both trials. Factors such as age, body mass index (BMI), weight, height, cholesterol, blood pressure, diabetes, medication use, smoking, glomerular filtration rate (GFR), and geographic region.

Although Dr. Janmohamed and his team stressed that only a small number of the test subjects underwent TRT and that most of them were American men, they found no discernible link between the therapy and risk of MACE.

The team writes that their findings “suggest that TRT [testosterone replacement therapy] is not associated with an increased risk of MACE in men with well-characterized coronary heart disease. The incidence of MACE was 11.1% in non-testosterone treated males and 7.9% in males on TRT.” They also noted that the data does not “corroborate recent observational reports that testosterone therapy is associated with increased CV risk.”

The report comes at a time when TRT is hotly contested as an effective method of treating low testosterone. If left untreated or diagnosed, low testosterone can lead to weight gain, chronic fatigue, reduced muscle mass, low libido, and other medical conditions. Pharmaceutical companies offer synthetic testosterone as a form of TRT.

Critics claim that the therapy is unnecessary and can increase the risk of cardiovascular illnesses, among other things. Some critics sight recent studies and data that demonstrate these risks, although there are other studies, such as Dr. Janmohamed’s, that find the opposite to be true.

Regardless, the studies have not stopped pharmaceutical companies from churning out TRT drugs due to increasing demand. Most recently, pharmaceutical giant Endo International released a new TRT called Natesto on March 16th.

As reported by the Philadelphia Business Journal, Endo claims that the new drug is the first and only nasal spray product on the market approved by the Food and Drug Administration (FDA). The FDA approved Natesto in May of last year.

It should be noted that Dr. Janmohamed’s study was composed of authors employed by GlaxoSmithKline, a pharmaceutical company known to produce and distribute TRT drugs.

Low testosterone is a serious medical condition that can lead to high blood pressure, weight gain, loss of muscle, low libido, and depression. Studies have shown that men with low testosterone have a 33% greater risk of dying during the next 18 years of their lives compared to men who have normal testosterone levels.

After-School Activities Boost Children’s Confidence

A West Covina, California gym owner is making a difference in the lives of school-aged children, offering free running, cardio, and weight lifting classes after school four days a week. Called “Maria’s Kids After School,” the program allows children between 12 and 17 years old to go to CrossFit Insurgent after 3 p.m. for an hour of learning and exercise.

CrossFit Insurgent owner Brian Franzen first started the program to provide guidance for children whose parents could not afford organized sports. Some parents even have multiple children in the program. Corrine Carmona has had three children participate.

“Everywhere else you go, you have to pay,” she told the San Gabriel Valley Tribune. “I think it was so awesome of him to do that for the kids. There are a lot of parents who can’t afford it.”

As children between 10 and 16 increase their amount of physical activity, their self-esteem and self-efficacy improve.

Franzen created his after school program to help children learn. Telling the San Gabriel Valley Tribune about the recreation center where he spent much of his childhood, Franzen explains: “I learned responsibility and discipline. I feel like it’s my turn to provide something like that for the kids and families who may not have the funds to put them through organized sports.”

Teens in Danville, Kentucky are also working with similar goals in mind. Ellie Begley and Maddi Karsner, of Boyle County High School, have volunteered to teach gymnastics at the Kentucky School for the Deaf (KSD).

Gymnastics class at KSD is once a week, and is open to boys and girls of elementary school age. In the summer, class will be offered twice a week as a part of summer school, and the teens hope to continue teaching in the fall.

Because neither teen is proficient in sign language, they rely on interpreters, teachers, and parents to help them communicate with the students. In return for gymnastics training, the students are helping the teens learn to sign.

Ramona Karsner, Maddi’s mother and leader of KSD’s kindergarten through eighth grade program, has noticed the students gaining more confidence and stamina, telling the Advocate-Messenger,”These girls get to help carry on their love for gymnastics and cheer and build that into the kids…It’s a win-win situation.”

Parents wishing to enroll their children in similar programs are encouraged to look for after-school activities in their area.

Chiropractor’s Acupuncture Needle Collapses Woman’s Lung, Lawsuit Alleges

A San Diego woman is suing an unlicensed acupuncturist, claiming that a procedure he mishandled caused her lung to collapse.

“I remember I was sitting there… having a hard time breathing, so I kept trying to take a deep breath,” plaintiff Jaime Del Fierro said. “I didn’t know if it was a nerve that was hit or a muscle, and maybe when I breathe it was kind of pinching the nerve, I had no idea. I mean anytime I had acupuncture before I had great results.”

Del Fierro went to Dr. Walker Scott for help with her ongoing tension headaches, paying him for chiropractic adjustments and for acupuncture procedures. When she told Scott about the pain, she says he dismissed her symptoms and sent her home. Several hours later, Del Fierro took herself to a hospital, where she then underwent surgery for what doctors told her was a collapsed lung.

“It was really, really scary for me,” she said. “I kind of went into like a really dark place because I faced mortality.”

According to the lawsuit, one of Scott’s acupuncture needles “pierced through plaintiff’s chest wall and into the pleural space surrounding her lungs, causing acute pneumothorax, a collapsed lung.”

Now, Del Fierro is suing Scott for thousands of dollars in hospital bills and damages. Sean Foldenauer, Del Fierro’s attorney, said that the lawsuit also seeks a court injunction for Dr. Walker Scott to stop performing acupuncture on patients.

Though he would not comment on the specifics of the case, Scott did say in an interview that the lawsuit came as a big surprise.

“This is my first time ever dealing with anything of this magnitude, so I guess I’ll have to say, you know, I wish I could tell you way, way more but you’ll have to give it a little while and I’ll get back to you,” he said.

In order to guard against such incidents and ensure that practitioners are properly trained, it takes five years and over 3,000 hours for the California state board to grant a license to a practitioner.

Though his website lists “electro-acupuncture” as an area of practice, state records show that Scott does not have an acupuncture license.

“It’s really important to do your homework because had I known that he wasn’t licensed, I never would have went to see him,” said Del Fierro. “I just don’t want anybody to suffer like I did. I don’t want it to ever happen again.”

Why Bumper-to-Bumper Bus Ads Aren’t Leaving State College, PA Anytime Soon

The Centre Area Transportation Authority (CATA), which serves State College, PA, has said the massive, bumper-to-bumper graphic advertisements that currently emblazon the sides of its buses are here to stay.

According to a February 16 StateCollege.com article, these wrap-around ads were first applied to four CATA buses in January 2014 as part of a year-long test run. In a recent meeting, CATA board members voted to make these wraps permanent, which means all CATA buses will now be emblazoned with these giant ads.

Mobile advertisements such as vehicle wraps are among the most effective methods for generating brand exposure, as more than 95% of Americans report being reached by mobile advertising regularly.

The CATA vehicle wrap ads cover almost every inch of each bus, including most of its windows. For obvious safety reasons, the front windshield and front-side windows are not covered.

Public reception to these mobile billboards has been largely mixed. Some people voiced concerns about the bus windows being covered; however, many CATA riders told StateCollege.com that the bold advertisements don’t bother them.

“Overall, the input we received was very positive,” CATA spokesperson Jackie Sheader explained. “There were a couple of concerns, mainly about aesthetics and maintaining the CATA brand on our buses.”

The bus wraps have brought a major source of funding to CATA, which had been struggling financially up until this point — CATA would have had to cut the number of bus routes it offers if it hadn’t found a way to make more money. Sheader said the four trial bus wraps helped generate $35,000 toward CATA’s bottom line in their first year of use.

Full implementation of the bus wraps will be gradual. CATA plans to have 12 of its 71 buses covered in wrap graphics by July 1, according to Sheader. If every ad opportunity is purchased, these wraps could ultimately bring in as much as $120,000 in funding for CATA each year.

Georgia Woman Forced To Call 911 After Hospital ER Fails To Provide Treatment for Life-Threatening Condition

In most cases involving 911 responders and life-threatening medical conditions, patients call the emergency hotline before being transported to the nearest emergency room. But for Christy Mitchell, a Georgia resident with a rare pulmonary disease, simply going to the emergency room at Gwinnett Medical Center in Lawrenceville, Georgia was not enough — Mitchell actually had to call 911 after arriving at the hospital’s emergency room because she wasn’t getting the immediate care that she needed.

According to CBS 46 News, Mitchell suffers from a life-threatening disease that requires medicine to be “pumped into her body every two minutes” to ensure that her blood flow stays constant and transports enough oxygen to her lungs. When Mitchell’s medicine pump suddenly malfunctioned, she called a friend to drive her to the closest hospital right away.

But when she arrived at the ER, Mitchell says that she encountered some problems when she tried to explain how serious her condition is. After offering to call up the PA who works with Mitchell regularly, and who could explain her condition to the hospital staff more fully, Mitchell was told that calling the PA wouldn’t make a difference, since that medical technician worked at a different facility which had “no jurisdiction” at the Gwinnett Medical Center.

Left with no other choices — and no hope of receiving treatment before the dozens of other patients in the ER — Mitchell says that she left the hospital and proceeded to call 911 immediately.

“Making that decision to leave the ER was the hardest thing I’ve ever done in my life,” said Mitchell’s friend Brannon Chappell, who had driven her to the hospital.

Chappell then drove Mitchell to a nearby shopping center, according to Fox6 News, where an ambulance arrived and provided immediate treatment to restart her medication flow.

According to Fox6 News, the specialist who normally treats Mitchell stated that he wasn’t surprised by the incident — very few people suffer from the same pulmonary disease, meaning that very few emergency medical staff know how life-threatening it can be if the medication isn’t administered on time. Beyond inserting a regular IV, the specialist explained, the staff at Gwinnett Medical Center likely had no clue how or why Mitchell’s medication had to be administered.

Although Mitchell’s case is not the norm, it’s evidence of a growing problem among hospital emergency rooms: too many patients seek treatment at emergency rooms when they don’t really need it, and patients like Mitchell are left without adequate immediate treatment. Mitchell certainly couldn’t sit around in the ER waiting room for hours until the center was able to understand her condition — she couldn’t even wait the 15 minutes that patients often encounter at urgent care clinics.

The hospital has declined to provide any specific details about Mitchell’s incident, citing mandated privacy regulations, but it did release a statement saying that “[ER] patients are assessed and treated based on acuity [and] initiation of certain treatments require physician orders to ensure patient safety.”

Study: Resistance Regarding Electronic Health Records Culturally, Not Empirically, Based

Hospitals and doctors’ offices across the country have worked in recent years to adopt electronic health records, spurred largely by the 2011 Health Information Technology for Economic and Clinical Health (HITECH) Act and its financial incentives. But critics say these EHRs have not been shown to significantly improve patient care quality, and may even leave patients vulnerable to having their information stolen.

According to a recent study, however, the real reason such anxiety surrounds the implementation of EHRs is simply fear of change among medical professionals. “They want to stick with what they know works,” co-author Jaeyong Bae, of Northern Illinois University, said in a March 5 news release.

Bae, along with William E. Encinosa of Georgetown, found that hospitals that do not use EHRs see a 14% increase in medical errors over those that do. Because of this and other factors, their study concludes that cultural changes, and not efficacy, are the real impediment to expansion and more efficient use of EHRs.

The study has been published in the March issue of the journal Healthcare.

 

The Question of Interoperability

Another major criticism of EHRs is that current efforts — including billions of dollars in public funds awarded through the HITECH Act — have done little to address interoperability, or sharing of EHRs among practitioners.

Part of the vision of EHRs is that doctors will be able to pull up information from visits with other providers and be able to better coordinate care, but even Bae acknowledges this is not yet fully a reality.

Because providers use many systems, most of which are incompatible with one another, it’s fairly common for one practitioner to receive patient information via fax or in physical form, then have to actually enter it into a new EHR.

Interoperability was even the subject of a scathing blog post written by five American senators and released on the Health Affairs blog March 4. “What have the American people gotten for their $35 billion dollar investment [in the HITECH Act]?” the authors ask. “… There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.”

Utah Public Health Official Warns That Measles Danger Has Not Passed

After a California-centered measles outbreak that has affected at least three Utah residents — as well as 146 others in seven states, Canada and Mexico — Dr. Joseph Miner of the Utah County Health Department is still concerned that the public is not as knowledgeable as it ought to be about the potential for a serious outbreak in the state.

“Because the vaccine has been so successful, a lot of parents think they are not at risk and don’t know how serious [outbreaks] are,” Miner told KSL News Feb. 17.

Many of those affected by the California outbreak either visited Disneyland or were in contact with other park guests or workers. The strain contracted by the patients is similar to one prevalent in the Philippines, which is unsurprising given the number of out-of-country tourists who visit the amusement park every year. Most of the infected people had not been vaccinated.

All three of the cases in Utah involved unvaccinated teens from the same family.

Miner said it’s important that people look to history for perspective on just how seriously measles should be taken, and let that guide both policy debates and personal decisions regarding vaccination opt-outs.

“Cemeteries have many, many gravesites of infants, toddlers and preschool children who died from vaccine-preventable diseases,” he warned. “We could easily return to that if people decided they didn’t want to immunize.”
A National Focus on Measles

The most recent outbreak has also spurred conversation on a national level. The Centers for Disease Control and Prevention issued new guidance on the treatment of measles Feb. 20, saying that Vitamin A should be used.

Patients should be treated in airborne isolation rooms to prevent the transmission of the highly contagious disease, and people showing symptoms are being encouraged to call their healthcare providers for guidance instead of just showing up in clinics or emergency rooms, since a lack of adequate preparation places other patients at risk.

The good news, at least, is that modern tools in the form of electronic health records are helping physicians and public health officials to better track immunizations and urge non-compliant patients to come in for the necessary shots.

As of 2013, about 69% of physicians reported that they had already applied or intended to apply to participate in the Medicare or Medicaid EHR incentive programs — one major driver of the rapid adoption of electronic records — and having such records makes it far easier for staff to rapidly contact people who may simply have forgotten about the vaccination schedule, rather than purposefully chosen not to vaccinate.

The MMR (measures, mumps and rubella) vaccine is typically given in two doses, the first between 12 and 15 months of age and the second between ages four and six.

Utah Spent $115,000 Containing the Measles Outbreak

Since December, controversy has raged over an outbreak of measles that occurred at Disneyland and quickly spread across the United States. In recent weeks, most of the debates and fears have centered around the importance of vaccinations and the likelihood of this highly contagious disease causing a serious outbreak. However, as health officials begin to suggest that their states are safe, a new question is emerging: how much does it cost to manage an outbreak of an illness like the measles?

This query was recently answered in Utah, only days after state public health managers announced that the area’s measles outbreak was over. The ordeal began when two unvaccinated minors from Utah County returned home after a visit to Disneyland in mid-December. Before testing positive, the patients unknowingly exposed hundreds by visiting movie theaters, grocery stores, and church services. But while officials from the Department of Health stated that as many as 400 people could be affected, only one other patient, also unvaccinated, contracted the disease.

This unexpectedly positive outcome was the result of the constant effort of local health departments, who conducted numerous case investigations, assessed patients, and reviewed immunization records. Staff members also made more than 1,600 phone calls to 117 potential patients, who were quarantined and monitored daily. As part of these efforts, the Utah Public Health Laboratory conducted 29 laboratory tests, sending two samples to the Centers for Disease Control and Prevention (CDC). Meanwhile, the Utah Poison Control Center responded to 300 calls from the public and the Utah County Health Department provided 586 measles, mumps, and rubella vaccines in January, logging more than 600 staff hours to meet public demand.

All in all, 90 Utah public health employees spent a total of 3,000 hours managing the measles outbreak. As a result, it has been estimated that the state spent $115,000 working to contain the virus cluster. However, this amount does not include indirect costs, such as public education, medical consultations, and private health care expenses.

While the state outbreak has been declared over, public health officials will continue to track any potential new cases. To prevent another outbreak, people are encouraged to get vaccinated for measles and other viruses if they have not done so already. If you cannot make an appointment with your doctor or find a vaccination program in your area, consider visiting an urgent care center. These walk in medical clinics offer a number of treatments for non-life-threatening conditions, as well as routine blood work, x rays, physical exams, and more.

Recalled Frozen Berries Contaminated With Hepatitis A Linked to Chinese Factory

Instances of food contamination in Chinese packing plants seem to have risen in frequency over the years, and this time it’s frozen mixed berries contaminated with hepatitis A that are making people sick.

Last week, Australian authorities began investigating after five people fell ill after consuming frozen berries distributed by Patties Frozen Berries.

The Guardian reports that those people have since been diagnosed with hepatitis A. According to the Centers for Disease Control and Prevention, symptoms of hepatitis A include fever, vomiting, fatigue, jaundice, joint pain, and dark urine. Contamination occurs after contact with the fecal matter of an infected person.

After an investigation, the contamination has been linked to a packaging plant. The berries are grown in Chile and China before distribution in Australia, but the contamination is thought to have taken place where the berries are packaged in China.

“The particular risk that we’ve identified here is that a country that has endemic hepatitis A, that is China, has been involved with packing these berries,” Finn Romanes, the department’s senior medical adviser, told Australian Broadcasting Corporation radio. “Clearly there’s strong evidence that there may have been a contamination during the packing process, as they are fully sealed and then transported to Australia.”

Patties Foods then extended the recall that was already in place, which covered all 1kg packs of Nanna’s Frozen Mixed Berries. The extended recall now includes 300g and 500g packs of Creative Gourmet Mixed Berries.

Among the more memorable food production snafus in China are infant formula (which killed six and sickened 300,000) and frozen strawberries that caused 11,000 German children to fall ill with diarrhea and vomiting in 2012. Food recalls fall under product liability, which has the second-highest median damage awards of all types of personal injury cases, garnering an average of $300,000.

According to the New York Times, food production and contamination in China have been a concern due to compromised water quality because of pollution and rapid industrialization, and poor and unsanitary factory conditions.