1. CASE STUDY: NuCalm and PTSD

    Make your appointment now at: 619-239-LIFE(5433)


    As many of you are aware, NuCalm was originally invented to treat acute Post-Traumatic Stress Disorder (PTSD). We all know someone suffering from addiction or PTSD, and we all struggle with finding ways to help them. Blake DeLoach tells his story here about the sacrifices he made to serve his country, living with his war wounds and how NuCalm is continuing to provide relief for his unseen injuries.

    Joseph “Blake” DeLoach, who is 30 years old, was born is a small rural town in South Carolina, not far from the U.S. Marine training base at Parris Island. From the time he was a young boy, Blake remembers having a deep love for the military. As a child, he dressed up in Army fatigues and playacted missions in his yard. “Even as a child I knew joining the military was what I was going to do,” Blake recounts, “and as soon as I came of age I tried to enlist in the Marines.”

    But Blake’s childhood was not all playacting and frolic. Far from it. When he was young, he and his older brother were abandoned by their unloving, alcoholic mother, leaving them in the sole care of his father. “I couldn’t ask for a better father,” Blake says. “He’s still the reason I am what I am today. He provided for us and we never went without a meal, although sometimes dad did.”

     Because his father worked the graveyard shift, he needed to sleep during the day. Since Blake’s brother was four years older than him, he was usually off spending time with his friends, leaving Blake mostly on his own. His feelings of isolation did not improve when Blake turned old enough to begin school. He didn’t enjoy school and found it difficult. Because of the loneliness he felt, Blake began to use drugs. “I was twelve or thirteen when I started using cocaine,” he admits. “That’s what I turned to because I really didn’t have anyone or anything else in my life at the time. There’s really no answer for why I did what I did. That’s just the way it played out.”

    Blake’s life took another turn for the worse when his mother came back into his life demanding time with her children. As a result, Blake says, “I got shuffled around like a bag of potatoes. I went to six different schools and just got tired of it.” Moreover, his difficulties with school did not improve. He was forced to repeat ninth grade three times because of his poor grades, and once he entered tenth grade and came of age, Blake chose to drop out of school. “I just wasn’t good at school,” he says. “I couldn’t understand it. It just wasn’t for me, so I dropped out.”

    In place of school, Blake found work through local temp agencies, biding his time until he could enlist in the military. During this time, using the money he earned, Blake paid for and passed a course to obtain his General Equivalency Degree (G.E.D.). Then, as soon as he was old enough, he went to enlist in the Marines, only to be told a G.E.D. was not enough to be accepted into the Corps. Disheartened, Blake returned home. “I didn’t even consider enlisting in the Army,” he says. “I wanted to be a Marine.” Then fate intervened. That same night, Blake received a call from an Army staff sergeant who had obtained his name and number from the Marine recruiting office. Blake returned to the recruiting office at 11pm and spoke with the sergeant until one in the morning. The next day, after taking and passing his qualification tests, Blake signed his enlistment papers to join the Army. “My goal was to get a combat-oriented job so that I could serve my country,” he says. “I didn’t want to be a paper pusher or anything like that. I’m a people pusher.”

    Based on his qualifications, Blake was offered positions in the infantry or as a cavalry combat scout in the 19th Delta. According to the U.S. Army’s website, a “cavalry scout is responsible for being the eyes and ears of the commander during battle. They engage the enemy in the field, track and report their activity and direct the employment of weapon systems to their locations.” Blake asked for more information about the cavalry scout position, insisting on an honest answer. “I was told, ‘Well, if you like hard work, long days, and getting dirty in the mud and so forth, you’ll love the job.’ I said, sign me up.” Blake was then told about the Army’s Airborne School, or Jump School. This interested him, so he signed up for that too.”

    It was during this time that Blake married his first wife, someone he’d known since sixth grade. One week later, he departed for six weeks of basic training at Fort Knox, Kentucky. Soon thereafter, misfortune again struck Blake. “I arrived for basic training on March 22, 2005,” Blake recalls. “By April second, my wife was already cheating on me with another man. That was a hard thing to go through, undergoing the hardest training of my life while learning my wife was cheating on me.” Blake got through this by choosing to focus on his training in the hopes that his wife would “come around” by the time he completed it. That didn’t happen. “I graduated jump school in September but she didn’t show up for the ceremony.”

    Given two weeks leave before he had to report for duty for his next assignment in Anchorage, Alaska, Blake returned home to meet with his wife, only to find another shock awaiting him. She revealed that she was pregnant but did not know if the child was Blake’s or that of the other man she had been seeing. Blake also learned that the other man was “a big drug dealer and drug user in the county.” Because Blake still genuinely cared for her he told her if she wanted to stay with him, he knew he could provide both her and the child a better life than the other man could. “So, I took her back and the baby, a boy, was born in January, 2006.” (Years later, Blake learned that the child was not his, but he accepted him as his son and never stopped loving and supporting him.)

    By then, Blake was stationed in Alaska, further pursuing his military training. There, despite his commitment to her and their child, his wife still continued to betray him, including writing multiple bad checks in his name that resulted in Blake nearly being arrested and having to undergo a criminal profile.  “It was a big mess,” Blake says, “but I stayed with her. Then I was deployed to Iraq, but before I left, I learned she was pregnant again.”

    In March, 2007, Blake was seriously injured for the first time while serving in Iraq. “I got blown up,” he deadpans. “I was on patrol walking down a street in South Baghdad when an IED (improvised explosive device) blew up about ten feet in front of me.” Despite suffering a shoulder injury and trauma to his brain, “I pushed through the mission, and then returned home later that month, in time for my second son to be born.” His respite home was short-lived, however. Two weeks later, Blake was back in Iraq “pushing through more missions” despite lingering problems with his shoulder. “Every time I would put on my gear, my arm would go numb,” he says. Eventually, it was determined that because of his injury he was experiencing poor circulation in both his arm and shoulder. As a result, he was medevaced home in June of that year, where he underwent intensive therapy to rebuild his shoulder. It was during this time that Blake first began to experience symptoms of post-traumatic stress disorder (PTSD). They manifested when he found himself unable to be around his infant sons when they cried. Their cries were too much for him cope with because while in Iraq the opposition forces regularly played recordings of babies crying and screaming. The memories of that triggered Blake’s response to his own children’s cries. “I couldn’t bear to be around them when they cried because it bothered me so deeply,” he says.

    Before much longer, Blake’s enlistment in the Army was coming to an end, but because of his desire to continue to serve his country, he wanted to re-enlist. Meanwhile, his wife again got pregnant and his third son was born in February, 2008. Blake re-enlisted so that he could continue to look out for his fellow Army colleagues and new recruits arriving in combat zones for the first time. “During my first tour of duty, none of us in my unit knew what to expect once we got to Iraq,” Blake explains. “I re-enlisted specifically so that I could help my new unit better prepare for what they might face over there. We were a smooth, solid unit, just a good group of guys. I was glad to be with them because the military was my heart, but it was also hard for me because I was unable to spend much time with my children. I think I was only able to be with them on their birthdays twice during that time” due to how life is in the military.

    Blake’s next tour of duty was to Afghanistan. Two months into his deployment there he learned that his wife had taken his sons and once again left him for another man. In order to cope, he kept his focus on his mission “and keeping my guys safe.” When he was finally able to return home on leave, Blake learned that the new man his wife had left him for was someone he’d protected from being beaten up when they were both in school “because he was a small guy, other kids liked to pick on him.” Before long, Blake and his wife divorced. Since then, she has refused to allow him to see his sons. “The last time I saw them, they were two, three, and four,” Blake says. “They were so little.”

    When Blake returned to Afghanistan he was assigned to a personal security detachment detail, where he was responsible for protecting a high ranking officer. “But I didn’t want to leave my unit,” he says. “Those guys were like family.” So, Blake did all he could to spend time with them while in Afghanistan. The prelude to the next major tragedy to strike Blake occurred on his birthday in October 2010. That day, he called his ex-wife hoping to be able to speak with his sons. She refused to let them come to the phone, telling him that she wanted him “to hurry up and get shot in the face and die” because she didn’t want to have anything to do with him.

    Three days later, October 18, 2010, Blake was assigned to accompany the officer he guarded to meet with local Afghani elders as part of a community outreach detail. But he soon discovered that the soldier assigned to replace him in his unit wasn’t even awake, let alone dressed and ready to accompany them on their next mission. Knowing that his unit was already short of men due to some of them being away on leave, Blake asked for and was granted permission to instead accompany his unit in what was supposed to be “just a simple mission”. It wasn’t.

    Soon after Blake and his unit set off, after they passed the first checkpoint, they were ambushed. The vehicle Blake was in was hit by a rocket propelled grenade (RPG) that landed inside it, where it exploded. “It broke my driver’s arm, and did a lot of damage to my face and eyes,” Blake recounts. “I lost my vision instantly and took a lot of shrapnel. My headset was completely blown off my head, my protective vests were destroyed, and so were my weapons. Basically, my entire crew was down.” Down, but not out. Despite being surrounded by dozens of enemy combatants, Blake says, “My guys, many of whom were also injured, swung into action, and we fought out of that tooth and nail, and sped back to the base.” En route, Blake’s right lung collapsed. “A piece of metal had punctured my ribcage, shattering my fourth and fifth ribs and blowing bone fragments into my lung, so I couldn’t breathe. I was also in severe pain, with wounds to the arteries in my neck. I was bleeding out and couldn’t receive painkillers because they would have thinned my blood, and I would have bled out faster.”

    Blake also could not talk because part of his jaw had also been fragmented. “Every time I tried to say something, some of my teeth would fall out.” Despite his extensive, serious injuries, when his unit returned to base he refused help until he could assist his squad members out of the vehicle. Only then did he allow himself to be placed on a stretcher and taken inside for care. Because of the severity of his life-threatening wounds, Blake was put into an induced coma, both to spare him from his pain, and in the hopes that he would somehow pull through. While in this unconscious state, Blake was visited by a general, who asked him if he was all right. “Apparently, when he asked me that, I was told that I gave him a thumbs up,” Blake chuckles.

    But Blake was far from all right. Days later, when he was finally brought out of his coma, his eyes were taped shut. He was told the doctors were unsure of his hearing, especially in his right ear, which had suffered the most damage from the grenade’s explosion. Nor were the doctors sure how well he would ever talk again because Blake had lost fifteen percent of his jawbone structure, as well as eight teeth. He’d also had a bad reaction to the anesthesia he’d been administered, leaving him with limited mobility, along with serious muscle loss. “I couldn’t even hold my head up,” Blake says.ut the biggest blow came when Blake was told he had lost his vision. The attack had left Blake irreversibly blind in both eyes.

    “The doctors asked me if they could do anything for me, and I asked to be alone for five minutes,” Blake says. “For those five minutes, I cried as hard as I could. I let my injuries win for those five minutes, but that was all I gave to them. Then I turned my focus on recovering as much as I could.” Blake worked diligently and determinedly on his recovery. Each day, he made a bit more progress until, one month later, he walked out of the hospital. “I walked out of there under my own power,” he says proudly,” holding onto my dad’s shoulder. I carried myself out of that hospital. I did that. Nobody else did that.”

    Blake left the hospital in December 2010, and continued to undergo therapy in Augusta, Georgia. During that entire time, his ex-wife refused to allow him to see or even speak to his sons, something she continues to do to this day. It was a terrible blow to Blake, on top of everything else he was enduring, yet with the characteristic courage and determination that by now Blake was becoming known for, he persevered. It was during his rehabilitation that Blake met Lauren, the woman he is now married to. Lauren was one of his instructors during his rehab therapy. “When we met I felt like I’d known her my whole life,” Blake smiles. Lauren was the first person who Blake felt loved him for who he is. “I didn’t know how to react to that at first,” he admits. He and Lauren took things slow in the beginning, starting out as friends. Eventually, though, they started dating and that led to the happy and fulfilling marriage that Blake once doubted would ever be his.

    When Blake and Lauren first met, he was on 26 different medications, most of which were narcotic drugs that Blake became addicted to. “I was self-medicating,” he says. “Lauren met me at my worst, yet she still saw the best in me. I don’t know how she did it, but she did, so I try every day to give a little bit more to her.” In January, 2014, Blake retired from the military after nearly nine years of service. The decision to do so was not his. Even with all of his injuries, Blake still desired to remain in the Army because he’d always wanted to spend his entire career serving his country, but because of his disabilities he was told he had to retire. The news sent him into a downward spiral of depression. “I was in a bad place,” he says. On one particularly low day, Blake “took a bunch of painkillers and alcohol” that caused him to have a seizure. Collapsing, he broke his back in six places. “I was so embarrassed by what I’d done that I lied to Lauren about what caused it,” he says. “I didn’t want her to think I was weak.”

    Blake continued to abuse painkillers on and off for another two years, but Lauren’s love for him finally led to break free of his addiction in 2016. “I did it on my own,” Blake says. “I went cold turkey, going through tremors, shakes, puking, all of that.” This lasted for seven brutal days. Since that time, Blake has maintained his sobriety. In his quest to continue to improve his health and maintain his sobriety, Blake began going to the gym to work out. He quickly discovered how much he loved doing so, especially lifting weights. As a result, Blake became a power lifter and now competes in competitions. “It’s such an amazing feeling to know I’m sweating because I’m doing something good and healthy for myself,” he enthuses.

    The progress Blake has made as a power lifter is remarkable. In one competition, he squat-pressed 363 pounds and bench-pressed 297 pounds. In April of this year, Blake traveled to Boston, where, because of his achievements, he and Lauren were selected to receive a fully adapted house by Homes for our Troops. Blake still marvels over this because of the mindset that was instilled in him during his time in the military. “When you join the military,” he explains, “the number one thing they tell you is you are not special, you’re just a soldier, and that’s it.” Being considered special is something Blake still has not gotten used to, though the manner in which he’s triumphed over all of the adversity he’s endured certainly attests to the fact that he is.

    This year, Blake also met his current, dentist, Dr. Marianna Kaufman. Since he was a child, Blake had always dreaded going to the dentist, but his experience with Dr. Kaufman has proven to be quite different. “She’s amazing,” Blake says. “She’s gentle with me and you can recognize the intelligence she has just in her voice. I could go to the VA for free, full dental care, but I don’t trust them.” Understanding Blake’s anxiety about dentists, a common phobia of many dental patients, Dr. Kaufman introduced him to the NuCalm system that she employs in her practice. “NuCalm has helped me quite a lot,” Blake says. “It’s helped me undergo three cavity fillings, as well as cleanings and other procedures.”

    Because of everything Blake has endured and the determination he has shown in refusing to be defeated by it, Dr. Kaufman wanted to find some way of giving back to him. To that end, she contacted David Poole, Executive Vice President of Sales and Marketing of Solace Lifesciences, Inc, the company that manufactures and distributes the NuCalm system. Upon hearing Blake’s story, David and Solace Lifesciences teamed up with Dr. Kaufman to gift Blake and Lauren with their very own NuCalm system. Given the experiences he’s already had using NuCalm in Dr. Kaufman’s office, Blake believes having his own system will be a big help for him as he maintains his sobriety.

    Blake is brutally honest about his struggles with addiction. “I’m an addict and I will always be an addict,” he says. “Anyone who says they were an addict is still in denial. Power lifting helps me stay sober, and now having Dr. Kaufman in my corner, and having NuCalm, the things that might make me want to use again are addressed through the NuCalm system. It keeps me calm. Before, I might choose a narcotic to do that, now I don’t have to anymore. NuCalm helps me stay strong.”

     “If anyone deserves the gift of NuCalm, it’s Blake, “David Poole says. “He’s given so much and served so many, and has received so little in return for his service and sacrifices. Our chief scientist specifically invented NuCalm for people like Blake to help them better cope and heal from addiction and PTSD. Both of those conditions keep the brain in a high state of stress. NuCalm relieves that stress and is the only system in the world to receive a United States patent because it does so.” Blake’s love for his country and desire to serve it remains as strong as ever, and the example of his heroic journey continues to inspire others. “I told myself when I found out I was blind that I was not going to let blindness win,” he says. “So, I’m pursuing things you don’t normally see blind people do. I want to be a change agent for my fellow veterans and give back to them by my example. That’s my goal.”

    To that end, since his injuries Blake has gone mountain climbing, surfing, and sailing. He’s also shot put and thrown the discus at the Olympic training center, which led to him getting recruited for the Paralympics. “Just for the fun of it, I also got certified as a scuba diver down to 60 feet and now I go diving off the reef in Key West,” Blake adds. “I’ve also taught myself music theory and I’ve taught myself how to play guitar.” Blake also intends to set records as a power lifter.

    When asked if he has any regrets, Blake immediately replies, “No. Because if I hadn’t done what I did, I wouldn’t be where I am now, which is a pretty awesome spot.” Even after triumphing over all of the tragedies and other challenges he has faced, Blake is not one to rest on his laurels. Instead, he continues to set new goals for himself while remaining focused on enjoying and appreciating the life he has created with his wife Lauren.

    In October 2017 Blake set personal records for himself in his most recent weight-lifting competition. “I squatted 446 pounds, bench-pressed 303 pounds, and dead-lifted 491 pounds,” he reports. “I’m hoping to squat 500 pounds very soon. My main goal right now is to get my numbers up high enough to where I can qualify to go to the nationals. If I can qualify, then I can get ranked nationally and possibly compete in the Arnold Classic and other major competitions.”

    Blake credits NuCalm with playing an important role in helping him achieve the personal best records he’s already set. “When I received my own NuCalm unit it was a month before my last competition. I was really stressed out about that, but then I started to use NuCalm. I did it twice a day, five days a week. Then, when it came time for the meet, I didn’t have any anxiety, which was completely shocking to me because I thought I would  be debilitated. Before I started using NuCalm, every time I would go to do a squat I’d get so anxious I’d be shaking. Sometimes I would even throw up. It was not good. Ever since I’ve been NuCalming I don’t have any anxiety anymore.”

    Because of the acute PTSD he developed due to his past tribulations, “I was flooded with paranoia,” Blake says. “I couldn’t eat without getting sick. I literally thought everything was going to make me sick.” Because of NuCalm, Blake says he’s been able to move beyond such feelings. “All of that has gone away or is so minute it’s barely noticeable.” The lack of anxiety Blake has achieved as a result of using NuCalm regularly also enabled him to recently undergo an extensive dental procedure with Dr. Kaufman to replace the teeth he lost during combat. “There is no way I could have done that before I started using the NuCalm system,” he says. “Because of NuCalm, I now have teeth that I hadn’t had for eight years. That’s a big transition. “When I go to see Dr. Kaufman I take my headset and my iPod shuffle with me and I use her CES part of her NuCalm unit. I put the electrodes on and I put on the NuCalm audio tracks and I relax very deeply. NuCalm has made a big difference. I don’t dread going to the dentist anymore.”

    Another significant benefit Blake has experienced since he began using NuCalm regularly is improved quality of sleep. “I can tell that my sleep is better when I use NuCalm compared to the times that I don’t use it,” he says. Even more importantly, Blake reports that NuCalm has changed the quality of his dreams, which previously could devolve into night terrors. For a long time, when I would dream everything would spin really, really badly. I looked that up and discovered that the interpretation of that sensation in dreams is because you feel that things in your life, the outside circumstances, are spinning outside of your control and the dreams are reflecting that. Since I got clean and started working with NuCalm with Dr. Kaufman and then on my own I don’t have that spinning or anything like that in my dreams. It’s very rare that I have any sort of night terror at all.” Blake’s dreams have also become more vivid. In them, he can see, and he often dreams he is telling people that he has his vision.

    Lauren has also noticed the positive differences NuCalm has made for Blake. “She knows that NuCalm has made a world of difference for me,” he says. “We both know that it’s made a big difference in things in terms of anxiety alone, and just day-to-day-wise. I don’t dread what the day might bring anymore, which is a big bonus.” Blake continues to use NuCalm five days a week. One Mondays, Wednesdays, and Fridays he uses it for an hour each day prior to going to the gym to train. “Depending on what else I have to do those days, I might also get another session in later,” he says. “Then on Tuesdays and Thursdays I also fit it in. There are several audio tracks that I like that really calm me down. I alternate between them.”

    Based on his own experience with NuCalm and the important benefits it has helped him achieve, Blake would like to see it adopted for use by the military so other men and women who are putting their lives on the line in service to our country can also benefit from it. He particularly sees it being useful after combat missions. “With a combat unit it might not be your day to go outside the wire, but if all hell breaks loose then everyone’s out doing their jobs,” he says. “Then, when you come back, you don’t get to leave what happened outside the wire. It sits on your shoulder until you deal with it. That’s where I think this system, for sure, could help.”

    At the very least, Blake would like to see NuCalm made available as a mandatory part of R&R when military men and women are able to return stateside for a temporary respite from war. He foresees NuCalm units being made available through the USO hubs in the Atlanta and Dallas-Fort Worth airports that veterans fly into when they come home.

    “The veterans could be given the option of signing out the units,” Blake suggests. “They could be told, ‘Hey, if you’re feeling like you’re overwhelmed, stop by the USO, sign out a unit, and take it with you on your R&R. Try to use it at least 25 to 30 minutes a day.’ And at the end of their R&R, they would return the system and it could be reissued to another veteran coming home. I think that would be a good foundation block because unfortunately nothing can prepare you for what you might face when you are deployed to combat zones overseas. Within three or four months of being in Iraq I lost friends. It doesn’t take long to have stuff just go wrong. I think NuCalm could help veterans deal with what they’ve seen and prepare them for what might come.”

    Asked what he would tell a returning veteran who is trying to assimilate back into civilian life about NuCalm, Blake says, “I would tell them, ‘I know this might sound silly, but it works. At first you might think there is just no way that can be true, but after repeated use you will find that it does help.’ I would also tell them that being in a third world country in a war zone takes a toll on you mentally no matter who you are, so if NuCalm is being offered, why not take advantage of a system that has scientific proof to help keep you from going down a bad path.”

    Make your appointment now at: 619-239-LIFE(5433)


  2. Obesity and Breast Cancer Ourcomes

    Research Report by Daniel Weber PHS, MSC, Panaxea

    Obesity not only is an independent risk factor of postmenopausal breast cancer (BC), and in particular oestrogen receptor-positive/progesterone receptor-positive BC, it is also a prognostic factor of the disease. Substantial evidence has shown that obesity, as measured by body mass index (BMI) is linked to BC outcomes. All-cause and BC-specific mortality risk increase for each BMI unit increase in pre- and postmenopausal BC survivors is estimated to range from 8 to 29 %, depending on when BMI is ascertained.

    Current evidence on treatment toxicity supports the guidelines from the American Society for Clinical Oncology, which recommends the use of full weight-based chemotherapy to treat obese cancer patients. Several studies have shown that lifestyle interventions are feasible and safe; more research is needed on specific diets for health maintenance and weight loss in BC survivors.

    Being physically active (≥150 min/week of moderate intensity activity) helps manage body weight (normal BMI 18.5-24.9 kg/m(2)), improves survival, and has secondary health benefits. Oncologists should recommend their patients to be physically active and control body weight when the conditions of the patient allow it

    Chan, D.S., & Norat, T. Obesity and breast cancer: not only a risk factor of the disease. Curr Treat Options Oncol. 2015 May;16(5):22. doi: 10.1007/s11864-015-0341-9.

  3. Study: Many Women with Breast cancer Can Skip Chemotherapy

    Research Report By Daniel Weber PHD, MSC, Panaxea 

    Daniel Weber cautions:

    “Professional advice is required, this is not something a patient or a practitioner untrained in oncology should decide. The article is generally correct but only specific testing will demonstrate which patients will benefit or which will need chemotherapy”.

    The New-York Times, By Denise Grady, June 3, 2018

    Many women with early-stage breast cancer who would receive chemotherapy under current standards do not actually need it, according to a major international study that is expected to quickly change medical treatment.

    “We can spare thousands and thousands of women from getting toxic treatment that really wouldn’t benefit them,” said Dr. Ingrid A. Mayer, from Vanderbilt University Medical Center, an author of the study. “This is very powerful. It really changes the standard of care.” The study found that gene tests on tumor samples were able to identify women who could safely skip chemotherapy and take only a drug that blocks the hormone estrogen or stops the body from making it. The hormone-blocking drug tamoxifen and related medicines, called endocrine therapy, have become an essential part of treatment for most women because they lower the risks of recurrence, new breast tumors and death from the disease.

    “I think this is a very significant advance,” said Dr. Larry Norton, of Memorial Sloan Kettering Cancer Center in New York. He is not an author of the study, but his hospital participated. “I’ll be able to look people in the eye and say, ‘We analyzed your tumor, you have a really good prognosis and you actually don’t need chemotherapy.’ That’s a nice thing to be able to say to somebody.”

    “The results indicate that now we can spare chemotherapy in about 70 percent of patients who would be potential candidates for it based on clinical features,” Dr. Sparano said.
    But Dr. Sparano and Dr. Mayer added a note of caution: The data indicated that some women 50 and younger might benefit from chemo even if gene-test results suggested otherwise. It is not clear why. But those women require especially careful consultation, they said. (Most cases of breast cancer occur in older women: The median age at diagnosis in the United States is 62.)

    The study, called TAILORx, is being published by The New England Journal of Medicine and was to be presented on Sunday at a meeting of the American Society of Clinical Oncology in Chicago. The study began in 2006 and was paid for by the United States and Canadian governments and philanthropic groups. Genomic Health, the company that makes the gene test, helped pay after 2016.

    This year, about 260,000 new cases of breast cancer are expected in women in the United States, and 41,000 deaths. Globally, the most recent figures are from 2012, when there were 1.7 million new cases and more than half-a-million deaths. Chemotherapy can save lives, but has serious risks that make it important to avoid treatment if it is not needed. In addition to the hair loss and nausea that patients dread, chemo can cause heart and nerve damage, leave patients vulnerable to infection and increase the risk of leukemia later in life. TAILORx is part of a wider effort to fine-tune treatments and spare patients from harsh side effects whenever possible. Endocrine therapy also has side effects, which can include hot flashes and other symptoms of menopause, weight gain and pain in joints and muscles. Tamoxifen can increase the risk of cancer of the uterus.

    Patients affected by the new findings include women who, like most in the study, have early-stage breast tumors measuring one to five centimeters that have not spread to lymph nodes; are sensitive to estrogen; test negative for a protein called HER2; and have a score of 11 to 25 on a widely used test that gauges the activity of a panel of genes involved in cancer recurrence.

    The gene test, called Oncotype DX Breast Cancer Assay, is the focus of the study. Other gene assays exist, but this one is the most widely used in the United States. It is performed on tumor samples after surgery, to help determine whether chemo would help. The test is generally done for early-stage disease, not more advanced tumors that clearly need chemo because they have spread to lymph nodes or beyond. The test, available since 2004, gives scores from 0 to 100. It costs about $3,000, and insurance usually covers it. Previous research has shown that scores 10 and under do not call for chemotherapy, and scores over 25 do. But most women who are eligible for the test have scores from 11 to 25, which are considered intermediate.

    “This has been one of the large unanswered questions in breast cancer management in recent times, what to do with patients with intermediate scores,” Dr. Norton said. “What to do has been totally unknown.” He added, “A lot of patients in that range are getting chemo.”

    Dr. Sparano said many patients have been receiving chemo because in 2000 the National Cancer Institute recommended it for most women, even those whose disease had not spread to lymph nodes, based on studies showing it could prevent the cancer from recurring elsewhere in the body and becoming incurable. “Recurrences were being prevented, and lives prolonged,” Dr. Sparano said. “But we were probably overtreating a lot of these women. For every 100 women we were treating, we were probably preventing about 4 distant recurrences.” Dr. Mayer said, “We couldn’t figure out who we really needed to treat.” The availability of the gene test in 2004 helped researchers sort out women with very high or very low risk. “But we really didn’t know what to do with women in the middle,” Dr. Mayer said. “Some seemed to benefit and some didn’t. We were back to square zero, safe rather than sorry, giving chemo to a lot who didn’t need it.”

    Data began to emerge suggesting that women in the middle were not being helped by chemo, and many doctors began recommending it less often. But a definitive study was needed, which is how TAILORx came about. The study began in 2006 and eventually included 10,253 women ages 18 to 75. Of the 9,719 patients with complete follow-up information, 70 percent had scores of 11 to 25 on the gene test. They had surgery and radiation, and then were assigned at random to receive either endocrine therapy alone, or endocrine therapy plus chemo. The median follow-up was more than seven years.

    Over time, the two groups fared equally well. Chemo had no advantage. After nine years, 93.9 percent were still alive in the endocrine-only group, versus 93.8 percent in those who also got chemo. In the endocrine group, 83.3 percent were free of invasive disease, compared with 84.3 percent who got both treatments. There were no significant differences. But the researchers wrote that the chemotherapy benefit varied with the combination of recurrence score and age, “with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25.”

    Bari Brooks, 58, a patient of Dr. Mayer’s from White House, Tenn., learned from a mammogram that she had breast cancer in 2009 when she was 49. Dr. Mayer told her she was a candidate for chemo, and also for the study — in which she might or might not get chemo. Could she handle the risk of missing out on a treatment that might save her life? Or the risk of side effects that might be needless? “It wasn’t even a decision I had to think about,” said Ms. Brooks, who works in human relations for Vanderbilt University. “It was yes, I want to do it.” She added: “You realize how insignificant everything is. Money, it doesn’t matter how much you have. Work, what projects you have, it doesn’t matter. What have I contributed in my life and what do I want to contribute? This was a situation where I could also contribute. I was honored and grateful to be part of it.”

    She decided that if she was assigned to chemo, “I would approach it that I was being cleansed rather than poisoned.”She did land in the group that got both chemo and endocrine therapy. Did the chemo help? Maybe, maybe not. She has no regrets. And no evidence of cancer. Dr. Mayer said that Ms. Brooks’ philosophical attitude was not unusual, and that women who signed up for studies understood they were taking a leap of faith and might wind up getting the ‘wrong’ or less desirable treatment.

    “They’re grateful that they helped to advance knowledge for other women,” Dr. Mayer said. “I never underestimate how nice and how altruistic people can be. Women look out for each other.”

  4. Screen Time for Kids

    By Leslie Hendrickson-Baral,

    Neurofeedback, Dyslexia, Asperger Syndrome, ADHD Testing, Irlen Syndrome, Think Fast Coaching, Sport-Mind Coaching
    Learn more about how screen time affects your children at Mom Loves Best

  5. Calls to Reign In Antibiotic Use After Study Shows 65% Worldwide

    Research report by Daniel Weber PHD MSC of Panaxea Int, from the  The Guardian, By Ian Sample, March 26, 2018

    A dramatic rise in global antibiotic consumption has led public health experts to call for fresh strategies to rein in excessive use of the drugs, and for major investments to provide clean water, sanitation and vaccines in countries where infectious diseases are rife. The unrestrained use of antibiotics is the main driver for the rise in drug-resistant infections which now kill more than half a million people a year worldwide, including 50,000 in Europe and the US combined. Left unchecked, the spread of drug resistance could claim millions of lives a year by 2050, according to a 2014 report for David Cameron, the former prime minister.

    Despite efforts to encourage more prudent use of antibiotics, an international team of researchers found a 65% rise in worldwide consumption of the drugs from 2000 to 2015. The sharp upturn, revealed in sales figures from 76 countries, was driven almost entirely by rising use in poorer nations, the study found.

    “We saw a dramatic increase in antibiotic use globally and this is mostly from gains in low and middle income countries where economic growth means they have greater access to the drugs,” said Eili Klein, an author on the study at the Center for Disease Dynamics, Economics and Policy in Washington DC.

    “While it’s generally a positive that there’s better access to effective antibiotics in these countries, there’s the potential for serious problems down the road from overuse. We know there’s a lot of inappropriate use in high income countries, and many of these lower income countries do not have the same controls in place.”

    Last month, Public Health England reported that at least a fifth of antibiotics prescribed by GPs in England for coughs and sore throats were unnecessary. A panel of experts convened by PHE found that while only 13% of people with a sore throat should get antibiotics, 59% did when they visited their GP.

    The danger posed by drug-resistant infections is so serious that England’s chief medical officer, Dame Sally Davies, has added antimicrobial resistance to the UK’s national risk register of civil emergencies. Five years ago, she warned of an “apocalyptic scenario” where people die of common infections and simple operations because antibiotics no longer work.

    “As access to antimicrobials improves it is inevitable that overall use will increase,” Davies told the Guardian on Monday. “It is crucial that we concentrate on appropriate use of quality-assured medicines in both humans and animals. The importance of clean water, sanitation and vaccination must not be forgotten to avoid infections occurring in the first place.”

    The latest study, published in Proceedings of the National Academy of Sciences, found that on average poorer nations still use antibiotics far less intensely than richer ones. In low and middle income nations, the number of “defined daily doses” handed out per 1,000 people rose 77% from 7.6 to 13.5 over the 16 years studied. But richer nations consume antibiotics at nearly twice that rate. According to the study, consumption rates in high income countries fell on average by a modest 4%, to 25.7 doses per 1,000 people.

    Of particular concern, the report states, is the steep rise in global use of antibiotics of last resort, such as colistin, a drug that has been reintroduced despite being all but abandoned in the 1970s because of its toxicity. Colistin has been used to treat infections that cannot be shifted with other drugs, but in the past decade bacteria with colistin-resistant genes spread around the world after they emerged in a Chinese pig in the mid-2000s.

    Klein and his co-authors criticise the global response to the public health crisis as “slow and inadequate”. They call for a “radical rethinking” of policies to reduce antibiotic consumption, and advocate major investments to boost hygiene, sanitation, and vaccinations in countries where antibiotic use is rocketing. Without fresh interventions to curb overuse, the number of antibiotics handed out globally could rise more than 200% by 2030, from 42bn doses per day in 2015 to 128 billion, the researchers predict.

    “In high income countries, the most important thing that reduced mortality from infectious disease in the 20th century was infrastructure,” Klein said. “Separating waste from drinking water and chlorinating it was one of the most important things we did.”

    Beyond clean water supplies, Klein said vaccination programmes could also help to curb excessive antibiotic use, and so drug-resistant infections. While antibiotics are not effective against viruses, vaccines that protect against the flu and viruses that cause diarrhoeal disease would reduce the number of people being handed antibiotics unnecessarily. “The reality is that a lot of antibiotic overuse is for viral infections,” Klein said.

    “Our modern medical system is built on effective antibiotics,” Klein added. “If our antibiotics stop working, if bacteria become resistant to most of them, medicine will be in trouble. The worry is that people don’t do anything about it.”

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