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Tuesday, April 9, 2019

Proton therapy shows efficacy, low toxicity in children with neuroblastoma

Researchers from Children's Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania analyzed the largest cohort to date of pediatric patients with high-risk neuroblastoma treated with proton radiation therapy (PRT), finding both that proton therapy was effective at reducing tumors and demonstrated minimal toxicity to surrounding organs.
The study is published online in the International Journal of Radiation Oncology.
"These data are extremely encouraging and could be a game-changer for a number of reasons," said lead author Christine Hill-Kayser, MD, Chief of the Pediatric Radiation Oncology Service at Penn Medicine and an attending physician at CHOP. "Not only did we observe excellent outcomes and minimal side effects that validate the use of PRT in high-risk neuroblastoma patients, we answered a lingering question about proton therapy -- the concern that because it is so targeted, tumors may come back. Tumors mostly did not come back -- suggesting PRT is effective, less toxic and a superior choice for our young patients who must endure intense treatment modalities in an effort to cure this high-risk cancer."
Neuroblastoma is the most common cancer in infants, accounting for more than 10 percent of all childhood cancer deaths. Primary neuroblastoma tumors are commonly adrenal tumors, which are very close to the kidney, liver, pancreas and bowel in children, making them hard to treat without harming vital organs in tiny bodies. Treatment usually involves a combination of therapies including chemotherapy, radiation and surgery.
Researchers studied 45 patients with high-risk neuroblastoma who received PRT at both institutions between 2010 and 2015. CHOP cancer patients who need radiation therapy are treated at Penn Medicine, including PRT through the Roberts Proton Therapy Center.
Unlike traditional photon radiation using x-rays, PRT is a non-invasive, precise cancer treatment that uses a beam of protons moving at very high speeds to destroy the DNA of cancer cells, killing them and preventing them from multiplying. Highly targeted, PRT has significant promise for treating tumors in very young children and may reduce radiation exposure to healthy, developing tissue that may result in lifelong impacts.
Five years after treatment, the longest recorded period of study in the largest cohort of patients to date, researchers observed excellent outcomes, with 82 percent of patients still alive, and 97 percent free of a primary site tumor reoccurrence.
Toxicities, or side effects, are measured on a scale from 1 to 5, with 5 being the most severe. No patient observed in the study experienced grade 3 or 4 long-term acute liver or kidney toxicity, with the majority of patients experiencing grade 1 side effects from PRT. "We've showed PRT is not only effective in the treatment of high-risk neuroblastoma, but it also spared damage to the developing liver, kidneys and bowel that may occur in pediatric patients exposed to traditional radiation," said Hill-Kayser. "While we look forward to longer-range data on these patients 10 years down the road, the excellent outcomes we see here, coupled with the fact the precision proton approach did not increase recurrence rates, support the expanded use of proton therapy in neuroblastoma and other high-risk childhood cancers." Additional studies with extended follow-up and larger patient numbers are planned. The Cancer Center at Children's Hospital of Philadelphia offers one of the most established and experienced pediatric proton radiation therapy programs, in collaboration with Penn Medicine at the Roberts Proton Therapy Center. For more information, please click here: Pediatric Proton Therapy Center.
This research was supported by institutional funds, without additional grant support.
Story Source:
Materials provided by Children's Hospital of Philadelphia. Note: Content may be edited for style and length.
Journal Reference:
  1. Christine E. Hill-Kayser, Zelig Tochner, Yimei Li, Goldie Kurtz, Robert A. Lustig, Paul James, Naomi Balamuth, Richard Womer, Peter Mattei, Stephen Grupp, Yael P. Mosse, John M. Maris, Rochelle Bagatell. Outcomes After Proton Therapy for Treatment of Pediatric High-Risk Neuroblastoma. International Journal of Radiation Oncology*Biology*Physics, 2019; DOI: 10.1016/j.ijrobp.2019.01.095
https://www.sciencedaily.com/releases/2019/04/190409153631.htm
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Alcon to Debut on NYSE Following Novartis Spin

Alcon (NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, announced its debut as an independent, publicly traded company and the completion of its separation from Novartis (NYSE: NVS). The company’s shares begin trading today on the SIX Swiss Exchange and New York Stock Exchange (NYSE) under the symbol “ALC.”
Alcon is the largest eye care device company in the world, with complementary businesses in Surgical and Vision Care. The company has a global presence in 74 countries and serves patients in more than 140, with fast-growing businesses in emerging markets. Alcon has the widest array of eye care offerings in the industry with products that can treat eye disorders at each stage of life.
“For more than 70 years, Alcon has been dedicated to helping people see brilliantly and now, as an independent company, we are pursuing even more opportunities to further that mission,” said David Endicott, Chief Executive Officer of Alcon. “We are poised to achieve sustainable growth and create long-term shareholder value as a standalone company. We have a long history of industry firsts and, as a nimble medical device company, we are sharply focused on providing innovative products that meet the needs of our customers, patients and consumers.”
Eye care is an approximately $23 billion a year market, growing at roughly 4 percent annually. Last year, Alcon had sales of $7.1 billion, including $4.0 billion in Surgical – up 7 percent from the prior year – and $3.1 billion in Vision Care – up 3 percent.
Under the terms of the separation, each Novartis shareholder or ADR (American Depositary Receipt) holder will receive one Alcon share for every five Novartis shares or ADRs they held as of the close of business on April 1, 2019, the record date for the distribution.
As an independent company, Alcon will have more focus and flexibility in pursuing its own growth strategy driven by rapid iterative innovation. The company will have a distinct investment identity with a more efficient capital structure that will allow it to expand markets, enter promising adjacencies and introduce new business models. These benefits, combined with Alcon’s industry-leading customer relationships, favorably position the company to achieve sustainable growth.
Alcon is headquartered in Geneva. The company has maintained a presence in Switzerland for more than 40 years and it is where the company was incorporated prior to the Novartis acquisition. Alcon’s facilities in Fort Worth, Texas, will remain a major operational center and innovation hub with a large base of employees.
Alcon will continue its substantial Corporate Giving efforts, which in 2018 included $62 million in monetary and product donations. Through its charitable organizations, the Alcon Foundation and Alcon Cares, Alcon partners with hundreds of charitable organizations to help increase access to eye care, providing sight-restoring surgeries, eye exams and other services to people in underserved communities around the world. Alcon also sponsors hands-on and virtual eye care provider training and skills-transfer to strengthen the level of care, and supports its communities through charitable donations and associate volunteerism.
Members of the company’s executive leadership team, Board of Directors and Alcon associates will celebrate the milestone by ringing the opening bell at the SIX and NYSE today, April 9.
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Whitening Strips May Damage Your Teeth

Having a pearly white smile may come with a significant cost — the health of your teeth.
New research suggests that over-the-counter whitening strips may be eroding the structure of your choppers.
“This study shows that there is a loss of protein from the teeth with these whitening treatments,” said senior author Kelly Keenan, an associate professor of chemistry at Stockton University in Galloway, N.J.
While the research looked at over-the-counter products, Keenan thinks those used by dentists might also do damage.
“Whether you buy over-the-counter or go to a dentist, it’s the same ingredient — it’s hydrogen peroxide. I don’t know of a safer alternative for whitening teeth,” she said.
But not everyone thinks Americans need to give up their love of a bright white smile.
“Anything that can harm the teeth concerns me, and I have read that whitening can soften teeth, but clinically, I’m not concerned,” said Dr. James Sconzo, chief of dental medicine at New York-Presbyterian Brooklyn Methodist Hospital. “I haven’t seen a higher decay rate in people who whiten their teeth.”
Sconzo, who wasn’t involved with the study, said he’s more concerned about damage to teeth from other things, like sugary sports drinks.
Americans spend billions of dollars every year on products to whiten their teeth, including whitening strips, researchers said.
Teeth are made up of several layers — the outer layer is protective enamel. The next layer is called dentin, which makes up the bulk of a tooth, according to the researchers. Dentin contains high levels of protein, and most is a substance called collagen.
Keenan and her team conducted three experiments with over-the-counter whitening strips. Whole teeth were placed in artificial saliva to try to mimic conditions in the mouth.
The teeth were treated with the strips for between 20 and 60 minutes (the time recommended), with a round of 20 strips.
The researchers saw that exposure to hydrogen peroxide in the strips caused the major protein in the dentin to be converted into smaller fragments. In another experiment, they treated pure collagen with hydrogen peroxide. The original collagen disappeared.
The study didn’t address whether teeth in their natural state in your mouth can regenerate proteins after exposure to hydrogen peroxide.
Sconzo suspects that’s probably what happens. “Dentin is a live cellular matrix,” he said.
He’s been whitening teeth for many years with a stronger concentration of hydrogen peroxide than was used in these experiments, and he “hasn’t seen any red flags,” he said.
“I have yet to see any clinical evidence that there’s damage to the teeth,” Sconzo said.
The American Dental Association would not comment.
The studies are to be presented Tuesday at the Experimental Biology meeting, in Orlando, Fla. Findings presented at meetings are typically viewed as preliminary until they’ve been published in a peer-reviewed journal.
More information
The AARP has more information on teeth whitening.
SOURCES: Kelly Keenan, Ph.D., associate professor, chemistry, Stockton University, Galloway, N.J.; James Sconzo, D.M.D., chief, dental medicine, New York-Presbyterian Brooklyn Methodist Hospital, New York City; April 9, 2019 presentation, Experimental Biology 2019 meeting, Orlando, Fla.
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Insurers’ Denials of Opioid Coverage Spurs CDC to Clarify Guidelines

People with severe pain from cancer or sickle cell anemia should not be denied coverage for opioid painkillers, a new clarification on federal guidelines states.
In the wake of the national opioid epidemic, various medical societies had encouraged doctors to rein in prescriptions for the powerful painkillers.
In 2016, the U.S. Centers for Disease Control and Prevention published guidelines that said for most patients seen by primary care doctors, opioids should be a last resort.
But there has been an unintended consequence: Some insurers have refused to pay for prescriptions for patients with cancer or sickle cell anemia, or for cancer survivors with complicated chronic pain conditions.
The new clarification was issued in a letter from the CDC to three medical societies who’d brought the insurance problem to the agency’s attention — the American Society of Hematology, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network.
The letter, released Tuesday, stresses that the guidelines weren’t intended for patients undergoing cancer treatment.
Beyond that, the letter says, the guidelines weren’t designed to “deny any patients who suffer with chronic pain” the option of opioid medications.
Dr. Deepika Darbari, who is with the hematology society, treats young patients with sickle cell anemia at Children’s National, in Washington, D.C. She said she’s come up against the insurance barrier herself — namely, plans that refused to pay for IV opioids for patients hospitalized with severe pain episodes.
And they’ve cited the CDC guidelines as the reason, Darbari said.
Sickle cell anemia is an inherited disease that causes red blood cells to be crescent-shaped, rather than disc-shaped. The cells also become “sticky” and prone to clotting. Because of poor blood circulation, patients can suffer periodic pain “crises.”
Over time, Darbari explained, sickle cell anemia can cause chronic pain by damaging organs and joints throughout the body.
Patients can first try other pain relievers, like acetaminophen (Tylenol) and ibuprofen (Motrin, Advil), along with nondrug therapies, according to Darbari.
But, she said, some need oral opioids, like Vicodin or OxyContin. And for severe pain episodes, patients may need to be hospitalized and given IV opioids.
The CDC agreed that managing sickle cell pain is complicated. The agency stated in its letter that treatment decisions — and reimbursement — should be based on medical guidelines created specifically for the disease.
Then there is the issue of cancer survivors who suffer lasting pain related to their treatment.
The CDC guidelines specifically said they do not apply to cancer patients undergoing “active treatment.”
“But where does that leave cancer survivors?” said Judith Paice, the lead author of ASCO’s guidelines on treating survivors’ pain.
More and more people are surviving cancer, Paice said — and that means more people living with aftereffects of treatment, which can include chronic pain. Some cancer treatments damage the nerves, for example, leaving people with a form of pain called neuropathy.
Another example, Paice said, relates to the aromatase inhibitors that breast cancer survivors may take for years to cut the risk of recurrence. They can cause chronic joint and muscle pain.
“We have many different options for addressing pain in cancer survivors, and opioids are one,” Paice said.
The CDC guidelines, she noted, were aimed at primary care doctors treating more common problems like lower back pain. Complex pain conditions, like those in cancer survivors, are different, Paice said.
In its letter, the CDC acknowledged that pain in cancer survivors is “unique,” and that guidelines from groups like ASCO offer “useful guidance” on treatment.
Commenting on the letter, the trade group America’s Health Insurance Plans (AHIP) said that health insurance policies have “always” recognized that patients under active cancer treatment do not fall under the CDC guidelines.
Beyond that, the AHIP said, “health insurance providers cover comprehensive, effective approaches to pain management that include evidence-based treatments, more cautious opioid prescribing, and careful patient monitoring.”
The CDC’s letter will be publicly available online, and Darbari said that doctors and patients can cite it if they run into problems with insurance coverage.
Paice called the letter “a beginning.” But she also said the problem is broader: Even when patients are not denied coverage, insurers put up cumbersome prior authorization requirements for opioids — even for refills.
“That can leave chronic pain patients without any medicine,” she said.
Paice said she reminds patients not to wait until their pills are almost gone to get a refill — since they may face delays.
More information
For advice on insurance coverage issues, visit the Patient Advocate Foundation.
SOURCES: Deepika Darbari, M.D., hematologist, Children’s National Health System, and member, American Society of Hematology, Washington, D.C.; Judith Paice, Ph.D., R.N., research professor and director, cancer pain program, Northwestern University Feinberg School of Medicine, Chicago, and lead author, Management of Chronic Pain in Survivors of Adult Cancers Guideline, American Society of Clinical Oncology; Cathryn Donaldson, director, communications, America’s Health Insurance Plans, Washington, D.C.; April 9, 2019, letter from the U.S. Centers for Disease Control and Prevention
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NYC Declares Public Health Emergency Over Brooklyn Measles Outbreak

A public health emergency has been declared in New York City as it grapples withone of the largest measles outbreaks in decades, which is centered in the ultra-Orthodox Jewish community in Brooklyn.
Unvaccinated people living in certain ZIP codes in Williamsburg, Brooklyn, will have to get the measles vaccine, and those who do not comply will be issued violations and possibly fines, Mayor Bill de Blasio said, The New York Times reported.
“This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately,”he said at a news conference in Williamsburg.
“The measles vaccine works. It is safe, it is effective, it is time-tested,”de Blasio added.
The nation’s largest metropolis is just one of many cities grappling with the return of measles, often fostered by “anti-vaxxer” sentiment that causes parents to forgo the measles-mumps-rubella (MMR) vaccine.
Across the United States, there have been 465 measles cases since the start of 2019, the U.S. Centers for Disease Control and Prevention reported Monday. The number of measles cases this year “is the second greatest number of cases reported in the U.S. since measles was declared eliminated in 2000,” according to the CDC.
Last year’s total was 372 cases. The largest outbreak occurred in 2014, with 667 cases,CNN reported.
There have already been 285 confirmed measles cases in New York City since the outbreak began last fall, city health officials said. Most have been in Hasidic Jewish communities in Williamsburg and Borough Park, Brooklyn.
Last December, New York City ordered students who were not vaccinated against measles to be prohibited from attending classes in ultra-Orthodox schools in selected ZIP codes, but city officials have admitted the order was not effective.
On Tuesday,de Blasio said the city would fine or even temporarily shut down yeshivas that did not abide by the order, The Times reported.
Nearby Rockland County, N.Y., is also struggling with a measles outbreak. As of late last week, there had been at least 166 confirmed cases there.
On March 26,county officials issued a 30-day emergency order banning unvaccinated children under 18 from being in public places such as shopping centers, businesses, restaurants, schools, and places of worship.
However, that ban was overturned by a judge last Friday.
Dr. Robert Glatter is an emergency medicine physician working at New York City’s Lenox Hill Hospital.
He stressed that measles can be very serious, even deadly in rare cases. And when parents choose not to vaccinate their kids against this highly contagious disease, it can make all kids more vulnerable, due to an overall decline in what’s known as “herd immunity.”
“Achieving herd immunity is the most effective way to reduce the risk to the population at large when some people in the population choose not to vaccinate,” Glatter said. “This includes the elevated risk to young infants as well as those who are immunosuppressed. Evidence suggests that herd immunity against measles is only achieved when 90-95% of the whole population is immune.”
Glatter also believes that deliberate misinformation about the “dangers” of vaccines, often spread via social media, is fueling the anti-vaxxer movement. Because of this, “the president of the American Academy of Pediatrics [AAP] recently sent letters to the CEOs of Google, Facebook to highlight the increasing threat that online misinformation about vaccination poses to children’s health,” Glatter noted.
In the meantime, outbreaks like those in New York City continue to spread.
“Measles is a highly contagious disease,” Glatter said. “People who are immunocompromised, as well as young children and non-immune pregnant women are at highest risk for severe complications.”
More information
The U.S. Centers for Disease Control and Prevention has more about measles cases and outbreaks in the United States.
SOURCES: Robert Glatter, M.D., emergency medicine physician, Lenox Hill Hospital, New York City; The New York Times, Apr. 9, 2019; CNN
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Indivior charged over alleged scheme to boost prescriptions

Indivior has been charged with engaging in a fraudulent marketing scheme to boost prescriptions of an opioid drug known as Suboxone Film that is used to treat opioid addiction, the US Department of Justice said Tuesday.
A federal grand jury in Virginia indicted Indivior on a range of charges related to the alleged scheme, including conspiracy to commit wire fraud, mail fraud and healthcare fraud.
According to the indictment, Indivior obtained billions of dollars in revenue from Suboxone Film prescriptions by marketing the drug as a safer and less abusable option than other drugs used to treat opioid addiction, thus deceiving healthcare providers and benefit programs.
The company was also accused of seeking to increase profits through a “Here to Help” programme by connecting addicted patients to doctors it knew were “were prescribing opioids at high rates and in a clinically unwarranted manner”.
Indivior said it would contest the case “vigorously”.
“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law. Key allegations made by the Justice Department are contradicted by the government’s own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong,” Indivior said in a statement.
Shares of Indivior, which was spun off from Reckitt Benckiser in 2014, are down 5.4 per cent this year. The shares have fallen 73 per cent in the past 12 months.
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FDA IDs harm reported from sudden discontinuation of opioid pain medicines

The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.
While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.
Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.
Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).
Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.
We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
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